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Das Execruit-Team bringt ein unvergleichbares professionelles Engagement mit, um Ihre Anforderungen in den Bereichen Talent-Rekrutierung, Führungsentwicklung & Beurteilung, Karriereentwicklung, Outplacement und E-Learning zu erfüllen.

Key responsibilities:
  • Continuously raise our profile of company in the industry as Drug Product Development experts seeking to be the preferential partners to target pharmaceutical companies
  • Bridge Chemistry and Final Dosage Form and therefore contribute decisively to offer a fully integrated package, attractive to both Small and Large Pharma
  • Continuously improve the performance of the DPD group, by being energized with breaking new ground every day and by providing an outstanding service to our partners
  • Ensure that activities are performed in an increasingly efficient manner and with the existing resources and within the agreed budgets
  • Supervise DPD projects ensuring perfect technical execution, customer satisfaction and the achievement of the established objectives
  • Promote continuously innovation and gains of knowledge within the company, proposing new differentiators (e.g. novel technologies or methodologies) for the company
  • Promote the company internationally through presentations, patents and scientific papers
  • Ensure all DPD activities are carried out according to Hovione HSE policy
  • Establish the technological strategy within his/her Group
  • Implement new methodologies within the DPD Group
  • Train team members in other CRD sites and guarantee common standards
  • Coordinate the work in the laboratories of the DPD group
  • Establish career development plans and training plans
  • Support technically the sales force and the Business Unit
  • Assess technically new projects
  • Supervise all projects within his/her Group
  • Write and approve technical reports
  • Prepare documentation concerning manufacturing processes, operating manuals and procedures.

Your profile:

  • With University degree in the field of Engineering, Science or Pharmacy, preferable in Chemical Engineering, Materials Sciences or Pharmaceutical Technology
  • With leadership, Team Management Communication skills
  • Excellent business sense
  • Result driven, team player, able to deal with multiple projects/tasks
  • Fluent in English (minimum CAE level)
  • Leadership and management skills
  • Experience in cGMP's and HSEE rules
  • With knowledge of Drug Product Development Technologies, Process Development and Optimization
  • Worked for a minimum of 4 years in the field of Drug Product Development technologies
  • Analytical minded
  • Problem solving
  • Availability, autonomy and ability to take ownership

Job Features

Job CategoryPHARMACEUTICAL DEVELOPMENT

Continuously raise our profile of company in the industry as Drug Product Development experts seeking to be the preferential partners to target pharmaceutical companies. Bridge Chemistry and Final Dos...

Establish and maintain excellent relationships between the company and Research Heads, CEOs, and Heads of Business Development of outside companies and leading university scientists to position the company as a credible in- and out-licensing partner.

Out-licensing

  • Develop and maintain a solid, active and trustworthy network of potential pharma partners, through a thorough understanding of their portfolio strategies and evolution.
  • Create on going visibility and interest in the company’s portfolio by strongly positioning the company portfolio to secure successful out-licensing deals.
  • Drive the sourcing and lead generation of potential partners, the identification and engagement with key decision makers, the due diligence process, the negotiations and conclusion of transactions.
  • Lead the building of a solid business frame and seek internal approval to conduct successful negotiations with prospective partners and secure deal closure.
  • Lead the development of deal structure and support their presentation to the company governance boards as appropriate, be responsible both for progressing, closing and terminating transactions.
  • Ensure that the company is regarded as partner of choice by third parties.
  • Represent the company in selected conferences and industry functions (such as BIO, JP Morgan, and other key partnering conferences).

In-licensing

  • Be the “project owner” in regard to in-licensing opportunities, lead the due diligence and the negotiation processes opportunities, in close collaboration with the Search & Evaluation representatives.
  • Seek out and generate data required to build robust BD&L business cases (financial models) that are aligned with insights generated during the due diligence process.
  • Create, own and present content for investment opportunities to the leadership team and executive committee, and present ongoing updates.
  • Ensure a smooth transition of business opportunities to operational activities once a deal is closed, in close collaboration with Program Management from the due-diligence, to the asset transfer.

Profile:

  • PhD (or Master) in Life Sciences, MBA a plus
  • 10 years of experience in Business Development, with a solid oncology knowledge and network strongly preferred.
  • Measurable Track record in negotiating and closing multiple value-creation licensing deals (out- and in-) in the biopharmaceutical industry, with a strong focus on early development transactions (up to Ph. II). Must have a strong deal sheet (applications without a deal sheet will not be considered).
  • Expert understanding of key principles of contracts, deal structures, intellectual property, value drivers and valuation principles of relevance for licensing, collaboration and related transactions.
  • Has developed a strong network amongst Research Heads, CEOs, and Heads of Business Development in the Pharmaceutical, Biopharmaceutical, and Biotech Industry as well as in Academic research centers.
  • Strong ability to build and nurture relationships with multiple external and internal stakeholders.
  • Expert analytical skills and ability to effectively understand and act on complex information under high time pressure situations.
  • Excellent communication and team player skills, including in situations of very high pressure, with the ability to lead cross-functional teams.
  • Outstanding ability to multitask and pre-empt future situations including at times of high pressure.
  • Gravitas and significant leadership and influencing skills and track record.
  • Expert project management experience and track record of proactive initiation of projects.
  • Significant track record in terms of independently leading and transacting major complex deals.
  • Strong judgement and decision-making skills in order to take responsibility both for progressing, closing and terminating transactions.
  • Solution and results oriented, looking for “Win-win” solutions, able to be creative to solve problems in order to achieve major objectives of parties involved.
  • Proactive, self-driven, and well structured, able to work in a rapidly shifting, fast-paced environment.
  • Excellent command of English, French language skills a plus

Job Features

Job CategoryBUSINESS DEVELOPMENT & LICENSING, LIFE SCIENCES

Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology - hematology) taking into account current medical practice and unmet needs; advances in both biological...

Key responsibilities:

  • Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology - hematology) taking into account current medical practice and unmet needs; advances in both biological sciences and data sources; as well as competitive environment;
  • Provide clinical leadership and medical strategic input for all clinical deliverables in the assigned program(s) to ensure: successful delivery of the development plan, anticipation and dealing with uncertainties; generation of scenarios and relevant information for decision making; and managing risks;
  • Clinical deliverables may include but are not limited to clinical study synopsis and protocol(s), Investigator Brochure, program specific standards, clinical components of regulatory documents/registration dossiers, publications, and in-/out licensing activities;
  • Deliver and execute the clinical development plan(s) in collaboration with study teams by ensuring: efficient execution of protocols, appropriate study medical monitoring, timely resolution of issues and reporting of study results including communication at congresses;
  • Be an integral member of the clinical development team and drive execution of the clinical program(s) in partnership with other functions (e.g. Clinical Scientist(s), Project Management,  Clinical Operations, Biostats, Regulatory Affairs and Business functions) to support decision milestones, regulatory requirements, market access and potential out licensing;
  • Responsible for the generation of the Clinical Development Plan (CDP) and is a major contributor to the Target Product Profile (TPP) and Integrated Project Plan (IPP). Present CDP and other study project-related topics to Leadership Team for validation;
  • Consult with internal and external experts for the generation of an innovative and optimal Clinical Development Plan including design and timing of individual study protocols;
  • Develop a network of Key Opinion Leaders /investigators, interact with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., study teams, Translational Medicine, Regulatory Affairs), and internal decision boards;
  • Provide Clinical Development input in due diligences both for the in-licensing and out-licensing of compounds;

 Your profile:

  • Medical Doctor with adequate clinical experience in oncology; Expertise in solid tumors is a must. Expertise in hemato-oncology or radio-oncology is a strong plus;
  • At least 7 years of successful and solid experience in oncology early and late drug development (from First In Human to Phase III study) in the pharmaceutical industry, including in best practice big pharma;
  • Evidence of keeping up to date with the recent development in clinical practice and scientific progress;
  • Track record of having led at least one oncology development program through different stages;
  • Proven track record delivery and publication of clinical trials in oncology and/or hematology. Open-mindedness, flexible, with a high level of scientific / medical curiosity and strategy mindset;
  • Being able to deal with uncertainty, manage risks and drive a proper decision making;
  • Proven strategic thinking and innovative mind-set, combined with project management and operational skills;
  • Leadership and ability to collaborate in a team within a matrix organization, while remaining autonomous and entrepreneurial minded;
  • Proven ability to establish strong scientific partnership with key stakeholders;
  • Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process and of ensuring compliance with GCP, SOPs, and regulatory requirements.

Job Features

Job CategoryCLINICAL DEVELOPMENT, LIFE SCIENCES

Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology - hematology) taking into account current medical practice and unmet needs; advances in both biological...

Key responsibilities:

  • Lead and manage a team of Clinical Trial Leads, ensuring smooth completion of studies as per plans, plan resources, recruit talent, establish meaningful development plans, address performance issues and ensure proper issue resolution as appropriate;
  • Lead and manage multiple clinical programs through the direct supervision of Clinical Operations Leads / CTLs, and in close collaboration with R&D cross-functional teams, ensuring smooth execution of studies (including budget and contracts review);
  • Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees when warranted; accountable for operational risk management strategy in collaboration with external partners.
  • Establish solid external providers CROs/Vendors selection and oversight, as well as preferred supplier strategy;
  • Improve Clinical Operations processes when needed, identify issues and propose solutions and action plans to be implemented by his/her team or by the extended Clinical Operations team, when appropriate, support functional initiatives and processes managed by Clinical Operations Department;
  • Provide direction for the development of operational plans including enrollment models and risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with CRO, be accountable for inspection readiness;
  • Provide direction and/or contribute directly to due diligence projects;
  • Be accountable for the review and expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), and updates to IND and NDA documents; provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2 and 3 Meetings, Request for Scientific Advice Meetings, etc.), as appropriate;
  • Collaborate and liaise with R&D functional managers, and/or Core team members as appropriate, champion and nurture cross-functional collaboration, and keep them informed if any issue is highlighted during study team meetings or with external providers;
  • Attend and represent Clinical Operations department in some of the Management Meetings (like Development Leadership Team/ DLT or Leadership team/LT, Protocol Review Board/PRB, etc.…) on ad-hoc occasions or to replace the Director of Clinical Operation, when necessary.
  • Additional responsibilities as Senior CTL (if applicable/ad hoc):
  • Lead multi-disciplinary team (CMC, Drug Supply, Regulatory, Pharmacovigilance, Data Management, Statistics, Clinical Development, …) in the design, start-up, conduct and closure of assigned clinical studies;
  • Manage operational aspects of projects including budgeting, study initiation and risk management in close collaboration with all involved R&D functions;
  • Select and manage external vendors, such as Contract Research Organizations (CROs), central laboratories, etc.;
  • Assist in the identification of investigational sites and perform co-monitoring with CRAs when required;
  • Represent clinical operations on multi-function project teams internally and externally; report on study progress;
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans;
  • Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company’s specific SOPs;
  • Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents;
  • Design, review and approve of all trial related documentation, and establish trial processes;
  • Give operational input (and scientific if appropriate) into Due Diligence activities.

Requirements

  • PhD is a plus or University degree or equivalent in Life Sciences;
  • 6-8 years of proven track record of Phase I-III international clinical trials management in the Pharmaceutical Industry, with people management experience. Previous monitoring experience preferred;
  • Oncology experience highly preferred;
  • Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals;
  • Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems;
  • Solid experience in management of CROs, vendors and consultants, experience in external audits, an asset;
  • Strong project management skills, excellent budgeting, planning, and communication skills;
  • Entrepreneurial and innovative; taking measured risks; thinking outside the box; challenging the status quo and comfortable with ambiguity:
  • Pragmatic and willing to drive and support change, supporting a culture of continual improvement and innovation; promoting knowledge sharing.
  • Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency;
  • Ability to lead and influence cross-functional teams and external partners;
  • Strong negotiation skills;
  • Strong scientific and in program strategy involvement, former experience in contributing to protocols and clinical development plans;
  • Fluent in English (French and another European language are an asset);
  • Ability to travel according to business needs (10-20%).

Job Features

Job CategoryCLINICAL OPERATIONS

Lead and manage a team of Clinical Trial Leads, ensuring smooth completion of studies as per plans, plan resources, recruit talent, establish meaningful development plans, address performance issues a...

Key responsibilities:

Procedural Document Management

  • Evaluate, design, optimize & implement the DPI Procedural Document (ProcDoc) Strategy in alignment with business objectives
  • Partner with critical quality & business representatives to drive the newly Quality Management System (QMS) module, more specifically Procedural Document Management System
  • Partner with Process Owners to design & implement well-defined process, ensuring integration of people, process and system components in business-critical ProcDocs
  • In collaboration with the business representatives, contribute to cross-functional process development & improvement initiatives
  • Act as a change agent supporting compliance and continuous improvement of critical business processes
  • Evaluate, design, optimize, implement the DPI Training & Learning Strategy and System in alignment with business objectives
  • Partner with critical quality & business representatives to drive the set up and implementation of the newly QMS module, more specifically Learning Management System
  • Establish and drive an effective role-specific learning and development structure and “just in time knowledge management” to enable the desired business results
  • Partner with Department Heads to ensure fit-for-purpose role-based training curricula are in place
  • Identify, evaluate, assess, and select external training vendors ensuring effective availability of effective training programs on specific topics
  • Act as a change agent supporting compliance and continuous improvement of DPI training activities in view of on-boarding and continuous learning.
  • Work with the Quality Leads to create and execute on engaging eLearning, instructor-led learning, virtual instructor-led learning based on experience from audit, inspection, CAPA and other sources
  • Ensure proper CAPA & KPI are developed and monitored
  • Training / Learning management
Your profile:
  • Master’s degree in a scientific discipline or equivalent combination of education and experience
  • Preferably 15 years’ experience in the Pharmaceutical or Biotechnology industry with a solid experience of at least 8-10 years in QMS in a GxP environment
  • Solid experience and expertise in design, harmonization, implementation, and optimization of cross-functional end-to-end business processes
  • Six Sigma certification/operational excellence and/or experience with process mapping tools and systems is desirable
  • Experience in understanding global regulatory GxP requirements and industry trends with the ability to apply them to process improvement
  • Experience in supporting Regulatory Inspection and Due Diligence activities
  • Significant experience with QMS tools, more specifically Procedural Document Management System and Learning Management System
  • Functional planning experience & ability to develop functional vision, priorities and tactics
  • Strong leadership, pragmatic collaboration and influencing skills in a complex, matrix environment
  • Experience in mentoring, coaching and directing people to ensure proper implementation of the management-endorsed strategy
  • Strong team player, with excellent interpersonal communication skills
  • Used to simultaneously support multiple projects, duties and assignments and prioritize accordingly
  • Self-dependent way of working; taking ownership of assigned tasks; plan and deliver according to agreed timelines
  • Proficiency in English (C1 Oral & written), fluent French is an asset

Job Features

Job CategoryLIFE SCIENCES, QUALITY ASSURANCE/COMPLIANCE

Procedural Document Management. Evaluate, design, optimize & implement the DPI Procedural Document (ProcDoc) Strategy in alignment with business objectives. Partner with critical quality & business re...

Key responsibilities:

  • Selects, recruits, develops, manages, motivates, coaches, and appraises the performance of direct reports to ensure high-quality results and support career progression through quality development plans
  • Manages Medical Writers and Clinical Scientists workload and ensures the proper allocation of resources to projects and studies to meet company objectives and priorities
  • Provides all necessary support to help address and resolve issues. Identifies solutions for remediation
  • Builds and establishes a strong team spirit and positive organizational culture, and creates a team founded on clinical, scientific and medical writing expertise, quality, technical ability, excellence in performance and exhibiting the values and winning behaviours
  • Acts as a Senior Clinical Scientist on programs on an ad hoc basis
  • Leads and supports certain projects and initiatives whenever applicable (for example Project Review Board, compassionate use programs) and supports the establishment of technical and professional skills for the Clinical Scientist and Medical Writer group and ensure staff training is conducted and properly documented
  • May act as a Subject Matter Expert for key operational areas influencing Clinical Scientist or Medical Writer Group area and identifies areas for process improvement
  • In collaboration with QA and Clinical Operations, manage audits and regulatory inspections related to clinical studies and create an audit readiness working environment.
  • Understands Health Authority requirements and is able to participate in Health Authority inspections as required
  • Ensure high quality clinical trial data and Clinical Study Reports /outputs throughout the project life cycle, in compliance with the processes, ICH GCP and regulatory requirements.

Your profile:

  • Master's Degree required, advanced Clinical/Science Degree is strongly preferred (e.g. PhD, MSN, MPH, etc.)
  • Experience in Oncology and/or Infectious Diseases is a plus
  • ≥7 years of relevant experience in clinical development within the pharmaceutical industry with focus on scientific, strategic and operational experience in planning, executing and reporting clinical development plans and clinical studies
  • Proven track record of leadership and people management
  • Understanding of principles of well-designed clinical trials, excellence in protocols, IB and other clinical and regulatory documents development
  • Medical/scientific expertise
  • Has knowledge of the multidisciplinary functions involved in drug development process (e.g.: clinical operations, biostatistics, regulatory, business, etc.) and can proactively integrate multiple perspectives into the clinical development process for best end results
  • In-depth knowledge of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation), clinical development process, clinical trial design, statistics, regulatory processes and relevant guidelines
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, and on-target. Flexible and open-minded, able to adjust to changing circumstances
  • Experience in due diligence activities
  • Strong interpersonal, verbal/written communication, negotiation and influencing skills.
  • Proven track record of effective decision-making: makes good business decisions and exercises sound judgment
  • Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with multidisciplinary teams. Demonstrate curiosity and challenge status-quo
  • Fluent English (oral and written)

Job Features

Job CategoryCLINICAL DEVELOPMENT, LIFE SCIENCES

Selects, recruits, develops, manages, motivates, coaches, and appraises the performance of direct reports to ensure high-quality results and support career progression through quality development plan...

Key responsibilities:

  • Coordinate outsourced activities, ensuring CDMOs accountability for the quality of their products and documentation as well as on-time delivery of the biotech APIs
  • Plan and coordinate team meetings with CDMOs and follow-on with actions
  • Review technical proposals from CDMOs
  • Review external documentation (protocols, reports, quotations, batch reports…)
  • Perform data analysis, data aggregation and reporting
  • Contribute to the preparation of CMC and regulatory documentation for biotech APIs
  • Ensure that external activities adhere to GMP, regulatory guidelines, standard processes and SOPs, where applicable
  • Propose process optimizations and recommend technologies in relation to bioprocessing
  • Assist with requests from Health Authorities
  • Keep aware of current scientific and regulatory knowledge as well as main actors in the field of biological products
  • Contribute to the development of internal expertise for bioconjugates

Your profile:

  • Engineering Degree (Biotechnology, Biology or Biochemistry)
  • Must have >7 years of experience in a Pharmaceutical or Biotech Manufacturing organizationin various stages of project development
  • Comprehensive understanding of the global development of biologicals from preclinical to late-stage clinical development
  • Direct experience in the manufacture of biotech products such as Antibodies and Antibody Drug Conjugates
  • Comprehensive understanding of CMC and regulatory aspects for biotech products
  • Knowledge of analytical requirements for biotech products
  • Expertise in working with sub-contractors and ability to coordinate external activities
  • Strong communication, team spirit and organizational skills
  • Direct management of cross-functional teams is a plus
  • English fluent spoken and written is mandatory

Job Features

Job CategoryTECHNICAL R&D

Coordinate outsourced activities, ensuring CDMOs accountability for the quality of their products and documentation as well as on-time delivery of the biotech APIs. Plan and coordinate team meetings w...

Posted 1 Jahr ago

Key responsibilities

  • Apply expertise in a scientific or highly technical area of specialty as an individual contributor or through contributing to/managing project teams in order to achieve results.
  • Actively contributes to the development and implementation of strategy for oral solid
  • Supervise projects, proving technical expertise and best practices to team members and ensuring the right networks are developed, internally and externally
  • Assess potential future activities from a scientific perspective and estimate the resources required, including costs estimation
  • Review and/or propose complex projects to promote innovative approaches that can lead to the generation of IP
  • Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about technical competencies and capabilities
  • Speak at Scientific Events and represent the company in international scientific forums
  • Address gaps in technical competencies by coaching and developing team members
  • Show business acumen, see the big picture and understand the impact of decisions on the business
  • Be regarded as a Subject Matter Expert within the company

Your profile:

  • PhD in Chemistry, Chemical Engineering, Materials Sciences, Pharmaceutical Technology or similar scientific field
  • Renown key opinion leader in oral solid platforms
  • At least 10 years of relevant experience, ideally in multiple companies/academia, with strong projection (papers, books and/or book chapters, podium presentations in key forums) in the space of inhalation
  • Very strong communication skills and strong network in the field
  • Fluency in English is a requirement

Job Features

Job CategoryLIFE SCIENCES, PHARMACEUTICAL DEVELOPMENT

Apply expertise in a scientific or highly technical area of specialty as an individual contributor or through contributing to/managing project teams in order to achieve results. Actively contributes t...

Posted 1 Jahr ago

Your responsibilities will be, but not limited to:

  1. Conduct deal making activities to bring new products in to the company’s pipeline:
    • Assess strategic business fit and attractiveness of new licensing opportunities
    • Interact with Search & Evaluation and Market intelligence representatives to build a business case (product attributes, competitive edge, market potential, exit strategy, financial modelling) for new opportunities
    • Present and defend business cases towards executive management in close collaboration with the Search & Evaluation Department to obtain a negotiation mandate
    • Structure, negotiate and close licensing deals in alignment with Head of BD&L and in accordance with the company’s business strategy
    • Contribute to updating the company’s licensing strategy by keeping track of the significant transactions and business trends in our areas of interest
    • Represent the company in selected business and scientific conferences
    • Participate and actively contribute to internal Licensing meetings
  2. Conduct, in alignment with Head of BD&L, out-licensing activities:
    • Nurture a solid external network of potential business partners, have a solid understanding of their portfolio strategies and evolution, and create ongoing visibility and interest in the company’s portfolio
    • Contribute to shaping a solid out-licensing strategy by keeping track of the significant transactions, the competitive landscape and business trends in our areas of interest
    • Drive the sourcing and lead generation of potential partners, the identification and engagement with key decision makers, the due diligence process, the negotiations, and conclusion of transactions
    • Contribute to building of a solid business case, seek internal approval to conduct successful negotiations with prospective partners and support deal closure
    • Run the development of deal structure and presentations to the company governance boards as appropriate
    • Actively participate into negotiations with partners
  1. As Business Representative within Global Project Teams play a key role in:
    • Bringing in the business vision within the core team on all strategic discussions
    • Identifying and generating value creation opportunities for the program
    • Ensuring alignment of development with needs/expectations of potential licensees
    • Driving the Out-licensing process and its implementation within the project team
    • Ensuring business awareness and alignment on the project with Senior Management

Your profile

  • Life Science academic education with additional business/funding experience
  • Over 5 years’ experience in Business Development with successful track record in licensing negotiations in the biopharmaceutical industry, non-for-profit organizations, or investments firms
  • Good understanding of financial models required to accurately assess deal structures and budgeting needs
  • Analytical skills, strategic and global thinking
  • Prior experience in oncology and/or antibiotics strongly preferred.
  • Excellent verbal and writing skills and a strong global health expertise to identify and engage influential stakeholders and funding partners
  • Team player with ability to collaborate and communicate within a matrix organization.
  • Ability to coordinate cross-functional teams (scientific, medical, regulatory, IP, legal…)
  • A problem solver, dynamic, entrepreneurial looking for win-win solutions.
  • Organized, proactive, self-driven, and able to work in a rapidly shifting, fast-paced environment.
  • Excellent command of oral and written English
  • Outstanding presentation skills

Job Features

Job CategoryBUSINESS DEVELOPMENT & LICENSING, LIFE SCIENCES

Conduct deal making activities to bring new products in to the company’s pipeline: Assess strategic business fit and attractiveness of new licensing opportunities Interact with Search & Evaluation...

Key responsibilities:

  • Following clearly defined briefs from our clients, your focus is to drive diligent filtering of applications, reviewing CVs, vetting candidates, interviewing and evaluating their experiences and skills – with the ultimate goal of developing strong short-lists of candidates for our clients.
  • Recruiting for executive, yet technically complex roles, is both a demanding and a rewarding experience. Our customers have high expectations and so do the prospective candidates.. Therefore, the need to be proficient about the industry and the target roles’ specifics are essential for success in this role.
  • This role is perfect for someone who is intellectually stimulated by complex and challenging missions, and sufficiently curious to make “finding a needle in haystack’ motivating.
  • There is a wealth of well-established tools and deployable approaches available to your disposal, in order to succeed in the role, internally and externally.
  • Your major deliverable on every initiative is a well-motivated and well-documented short-list of stellar candidate profiles.

Your profile:

  • Demonstrated ability to productively engage and communicate with various audiences
  • Strategic, analytical and methodical in approach to tasks
  • 5+ years of recruitment experience in Life Sciences (ideally for global roles)
  • Industry specific knowledge in the Life Sciences (some subject matter expertise)
  • Excellent written and verbal communication skills
  • Driving for and achieving results in complex environment
  • Self-drive (initiative) combined with open partnership and support seeking behaviours

Job Features

Job CategoryHR SERVICES

Following clearly defined briefs from our clients, your focus is to drive diligent filtering of applications, reviewing CVs, vetting candidates, interviewing and evaluating their experiences and skill...

Switzerland
Posted 1 Jahr ago

Key responsibilities:

  • Develop a “risk-based” compound-specific compliance program contributing to document / data accuracy, ultimately resulting in “dossier acceptability” by respective out-licensing partners (emphasis on eCTD Module 5)
  • Contribute to CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process to establish a pro-active quality approach, guaranteeing compliance with regulatory requirements
  • Collaborate with the Clinical Trial Manager and other Functional Area Representatives in the Study Team to ensure proper DPI set-up & oversight of outsourced CRO activities, with primary focus on critical data points (primary endpoints) and critical processes
  • Provide compliance support and contribute to “in process / ongoing” oversight through evaluation & follow-up on reported quality events potentially jeopardizing the validity of the clinical study
  • Collaborate cross-functionally to the development and review of critical clinical study documents to ensure cross-document consistency e.g. IB versus Clinical Trial Protocol versus Master Informed Consent Form, …
  • Applying the risk-based approach, identify the need to & conduct co-auditing activities / quality visits with DPI and / or CRO representatives
  • Provide continuous compliance support by acting as an internal advisor on relevant procedures and regulations to ensure correct interpretation and proper implementation
  • Create KQI to identify areas for improvement based on risk-based compliance activities and audit observations
  • Lead / contribute to compound-specific Regulatory Authority Inspections / Due Diligence Activities
  • Build collaborative working relationships and ensure adequate communication within the compound-specific study team and cross-functional Quality peers, assist in driving change to build a culture of compliance throughout the Clinical Development organization
  • Provide Audit / CAPA support to the execution of Master Audit Plan executed, assist the DPI business stakeholders to ensure proper CAPA formulation and follow-up
  • Provide support to the development / maintenance of QM andclinical developmentrelated procedural documents

Your profile:

  • University Degree in Sciences or relevant academic background
  • 6-8 years’ experience in the clinical setting of the pharmaceutical/biotech industry, including at least 3 years within Clinical Quality Management System & Compliance
  • Experience in managing and conducting GCP audits (CROs, TMF, Investigational Sites and CSR)
  • Excellence knowledge of GCP. Current and strong working knowledge of GCP, CFR Title 21 and regulatory guidance’s including, ICH quality, clinical, multidisciplinary guidance documents, and 21 CFR Part 11 compliance
  • Strong experience in the mechanism of multiple QA vendor’s oversight
  • Experience in setting and updating SOPs
  • Knowledge of computerized systems validation
  • Rigor, flexibility, adaptability and organization
  • Pragmatism focused on efficiency and continuous improvement
  • Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities
  • Fluent in English, French an asset

Job Features

Job CategoryLIFE SCIENCES, QUALITY ASSURANCE/COMPLIANCE

Develop a “risk-based” compound-specific compliance program contributing to document / data accuracy, ultimately resulting in “dossier acceptability” by respective out-licensing partners (emph...

Switzerland
Posted 1 Jahr ago

Key responsibilities:

  • Work closely with the Global Program Head(s) and Global Project Leaders (GPLs) to support/contribute to the development of the program strategy and its integrated development plan
  • Contribute to and/or coordinate the development of strategic documents and prepares for phase transitions in collaboration with the Development Teams
  • Responsible for strategy implementation and operational execution of the program (quality and accuracy of program plan and forecast in enterprise planning systems)
  • Coordinate team objective setting, prioritization, and tracking, collaborate with teams to identify key program issues; may lead or participate in ad-hoc cross-functional sub-teams and task forces to address and resolve issues
  • Contribute to risk assessment and contingency planning and communicates program status
  • Support Global Program Head(s) and Global Project Leaders in preparation of comprehensive program recommendations, board meeting presentations and updates for governance boards
  • Report on projects progress and deliverables
  • May manage/support external partnerships/collaborations
  • Support program management excellence and foster an enterprise mindset
  • Provide operational leadership to assigned teams, prepare and manage the effective coordination and facilitation of cross-functional team meetings from a program management perspective (agendas, minutes)
  • Contribute to functional excellence by supporting implementation of PM standards, team objectives, project documentation and communication
  • Provide Program Management expertise and leadership in the areas of planning, tracking, scenario-generation, contingency development, critical path analysis, and risk management
  • Develop and manage global, integrated cross-functional plans (Identifying key deliverables for each function)
  • Actively establish and maintain a close partnership with the Clinical Study teams and program extended teams to ensure alignment and overall program execution
  • Assure that functional deliverables are completed on time, on budget and according to quality standards; you take a hands-on approach if required to support the various teams
  • Prepare and present monthly reporting to team and stakeholders to show progress, results; anticipate risks and provide recommendations and solutions
  • Play an active role in driving process improvement & best practices on the program and in developing Project Management tools, templates, processes
  • Coordinate, elaborate and consolidate the writing of monthly, quarterly or annual reports of multi-projects progress and portfolio views
  • Actively contribute to promote the values of project management within the company

Team management:

  • Support Global Program Head(s) and Global Project Leaders to role model a leadership style which is inclusive, proactive, change agile and results driven with a collaboration focus
  • Partner with R&D team members to derive high performing team spirit with a trusting relationship, sharing responsibility and working towards joint goal
  • Support driving a continuous improvement mindset across the organization

Your profile:

  • Master or PhD (preferred) in Life Sciences
  • At least 6-7 years of experience in multi-cross-functional & multidisciplinary drug development teams within international pharma or biotech companies
  • Intermediate knowledge of special requirements of Oncology or Anti-infectives disease area specific drug development, including regulatory and business requirements
  • At least 3 years of experience in Project Management for preclinical and clinical development with Pharma or Biotech company, with hands-on project management skills, including project plans, timelines, budgets, resources, risk assessment and reporting
  • PMP or equivalent certification is an asset
  • Excellent planning, anticipation, and organizational skills, and good analytical thinking
  • Ability to anticipate & troubleshoot problems
  • Strong interpersonal skills for bridging between scientific and business participants
  • Team player with an open mind, able to constructively accept feed-back and suggestions for improvement.
  • Ability to handle multiple programs and responsibilities simultaneously on short notice and meet requirements in a fast-paced, high-expectation environments
  • Technology-savvy in all Microsoft Office applications; proficient in MS Project or similar planning tools
  • Fluency in English (C1), French is an asset

Job Features

Job CategoryDRUG DEVELOPMENT, LIFE SCIENCES, PROJECT MANAGEMENT

Work closely with the Global Program Head(s) and Global Project Leaders (GPLs) to support/contribute to the development of the program strategy and its integrated development plan.

Switzerland
Posted 1 Jahr ago
Key responsibilities
  • Guide innovation, provide drug development expertise and strategic leadership to the programs and project teams, comprising all pre-clinical, clinical, technical, regulatory, operational and commercial disciplines
  • Define the vision, overall development strategy and operational implementation for the assigned technology innovation programs based on regulatory and market requirements to obtain drug approval and maximize the out-licensing value of the programs
  • Identify Improved Therapeutic Benefits opportunities to expand product Life Cycle including product differentiation strategy.
  • Anticipate internal and external drivers of changes to strategy, and respond by making rapid, well-judged adjustments to the programs roadmap
  • Identify potential issues and risks; develop, align and implement mitigation plans in a transparent and timely manner
  • Drive proactive scenario planning and risk taking paths across the project teams
  • Develop team effectiveness and lead high performing project teams to achieve superior results
  • Jointly with the Global Line Functions and the Project Managers, align on staffing of Project Teams. Identify, resolve and escalate resource issues
  • Set goals, actively coach and contribute to the performance appraisal of the project team members in close partnership with the line-functions
  • Oversee execution of the Program strategy across all functions and sub–teams
  • Drive project operations in close partnership with the Project Managers
  • Communicate the strategy to the global project teams and functions, and ensure that the agreed strategy is reflected in the operational activities
  • Drive and steer the implementation of the Program strategy in close collaboration with the relevant functions within agreed timelines, budgets and resources
  • Define and implement clear measurable goals for program execution
  • Propose and manage, with the support of the Project Managers, the management of internal and external budgets related to the programs
  • Ensure adherence to quality and compliance
  • Represent the Programs internally and externally with objective advocacy of their potential and transparent disclosure of their risks
  • Secure internal alignment on vision and strategy with governance bodies, board members and across functions and departments
  • Develop and maintain external communication strategy around the Programs targeting different stakeholders such as patients and potential out-licensing partners
  • Shape the external environment to strengthen the company position related to the program by developing strong evidence and trust-based relationships with key stakeholders (regulators, KOLs, patient groups, scientific societies)
  • Maintain and develop a positive organizational culture, by promoting the values of the focus on patients, science, collaboration and people Alliance management leader for in-licensed, out- licensed or co-development projects.
  • Member of new opportunity evaluation due diligence team.
Your profile:
  • Scientific background, PhD and/or MD preferred
  • At least 7 years of experience in pharmaceutical drug development in areas such as pharmacology, clinical studies, CMC, ADME, Toxicology or translational medicine
  • Extensive end-to-end global drug development experience in Oncology, endocrinology, infectious and rare disease or bio-betters/biosimilars product development. Additional therapeutic areas, and/or proprietary drug development experience is a plus
  • At least 5 years of experience in Project Leadership from preclinical stage up to registration and launch or out license. Track record leading Life Cycle management project including formulation improvement, product delivery or combination opportunities improvement, including medical devices.
  • Experience in out-licensing and external opportunity assessment (development and business). Exposure to regulatory, manufacturing, pricing requirements/ challenges for development, registration and commercialization in US, EU and RoW
  • Solid business acumen and competitive landscape understanding in the relevant therapy area
  • Integrated strategic thinker across drug development functions with ability to scope and challenge their plans and deliverables
  • Understanding of multiple drug development disciplines (e.g. translational medicine, regulatory, pre-clinical pharmacology, CMC, clinical development and operations, market access, marketing, business development, project management)
  • Excellent strategic agility, willingness to experiment and take smart risks
  • Insight into and understanding of principles related to evaluating business deal structures including commercial collaborations, in-licensing and out-licensing deals, and divestitures
  • Experience in budgetary management and decision-making
  • Project management experience, mastery of risk management and deep understanding of the requirements for successful commercialization of biosimilars Proven ability to successfully deliver projects in a fast-paced environment with competing priorities under tight deadlines
  • Decisiveness, ability to lead cross-functional teams, and to drive results collaboratively in a matrixed team environment
  • Excellent communication and presentation skills, ability to interact at all levels of the organization
  • Strong ability to influence and align stakeholders at all levels and establish collaborative relationships with the external scientific and business community.
  • Outstanding scientific and analytical skills combined with superior problem-solving skills
  • Proven ability to manage, mentor and coach experts from different functions
  • Ability to communicate seamlessly with scientific and business stakeholders, to negotiate timelines, resources and to foster effective collaboration to deliver results

Job Features

Job CategoryLIFE SCIENCES, PROGRAM LEADERSHIP

Guide innovation, provide drug development expertise and strategic leadership to the programs and project teams, comprising all pre-clinical, clinical, technical, regulatory, operational and commercia...

Key responsibilities • Drive development of protocols/protocol amendments for clinical studies • Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, Safety Management Plan, Medical Monitoring Plan, SRC Charter, IND, briefing books) • Work closely with clinical team members within the assigned project to execute activities associated with the conduct of clinical trial • Contribute to development of end-to-end clinical development strategy • Prepare and/or provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses) • Monitor, review and interpret safety and efficacy data of ongoing clinical trials • Act as (clinical science expert) liaison to cross-functional project core team, clinical study teams, CRO's, study sites and others • Establish relationships with investigators, KOLs, partners and appropriate consultants • Provide clinical scientific input to business development (e.g. due diligence) and marketing activities • Perform literature research • Develop and deliver presentations to internal and external stakeholders. Provide input in scientific communication plan and scientific publications Your profile: • Master's in Life Sciences, Pharmacist or PhD in Life Sciences (preferred) • At least 7-10 years of relevant experience in clinical development within the pharmaceutical industry, including development of CDPs and protocols • Experience in conducting Clinical Studies in Oncology • First experience in working on prostate cancer is a strong asset • First experience working on studies in Anti-infectives in an asset • Broad experience in the principles and techniques of data review, analysis, signal detection, interpretation and clinical relevance • Well-versed in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines and regulations • Knowledge of the multidisciplinary functions involved in drug development process (e.g.: clinical operations, biostatistics, regulatory, business, etc.) and can proactively integrate multiple perspectives into the clinical development process for best end-results. • Driven and proven abilities to perform responsibilities independently and with limited guidance • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget delivery. Focused on results, flexible and open-minded, able to adjust to changing circumstances. • Strong interpersonal, verbal/written communication, negotiation and influencing skills in English • Proven track record of effective decision-making • Proven track record of working highly effectively, efficiently and collaboratively with multidisciplinary teams • Demonstrates curiosity and challenges status-quo

Job Features

Job CategoryCLINICAL DEVELOPMENT, LIFE SCIENCES

Drive development of protocols/protocol amendments for clinical studies. Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Ma...

Key responsibilities:

  • Be an integral member of the clinical development team and the clinical study team and drive execution of the clinical study in partnership with other functions
  • With appropriate supervision, manage the design and implementation of study protocols for a clinical development program in support of the overall Clinical Development Plan
  • Work closely with Pharmacovigilance, Clinical Operations, Regulatory Affairs, Biostatisticians and Business functions to ensure appropriate site selection, efficient execution of study protocols and overall timelines for key deliverables
  • Be responsible for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating study data pertaining to safety and efficacy of the compound internally, and where appropriate to forums externally
  • Contribute to analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents
  • Provide insights to the development and study team with regards to current medical practice and identify unmet need
  • May contribute to the generation of the Clinical Development Plan and Target Product Profile as the clinical representative for the protocols for which the incumbent has responsibility, when applicable
  • Participate in KeyOpinionLeader interactions related to clinical study and its disease area(s)
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May contribute to regulatory responses and discussions
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research

Your profile:

  • Medical Doctor with adequate clinical experience in oncology; This may include Oncology drug development experience from academia, looking to move into their first to industry role, or pharmaceutical drug development of at least 2 years Clinical or pharmaceutical experience in oncology (solid tumors) is desirable
  • Evidence of keeping up to date with the recent development in clinical practice and scientific progress
  • Open-mindedness, flexible and willing to learn with a high level of scientific / medical curiosity and strategic mindset
  • Being able to deal with uncertainty, manage risks and drive a proper decision making
  • Excellent written and verbal communication skills
  • Leadership and ability to collaborate in a team within a matrix organization, while remaining autonomous and having an Innovative mind-set
  • Knowledge of GCP, clinical trial design, statistical analysis methodology, and of ensuring compliance with GCP, SOPs, and regulatory requirements.

Job Features

Job CategoryCLINICAL DEVELOPMENT, LIFE SCIENCES

Be an integral member of the clinical development team and the clinical study team and drive execution of the clinical study in partnership with other functions

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