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Key responsibilities:

• As Subject matter expert, you will be responsible for the technical strategic programme in the field of continuous tableting
• Responsible for portfolio of projects within the programme, from ideation to launch including prioritisation, governance, resourcing and overall budget management
• Promotes the scientific excellence and innovation in the field of continuous tableting and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
• Lead the development and implementation of the R&D strategy for continuous tableting
• Supervise projects within the field of continuous tableting, providing technical expertise and support to the project leads ensuring the right networks are developed internally and externally
• Review complex projects within the area to promote innovative approaches leading to the generation of IP (patents or trade secrets)
• Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about Hovione technical competencies and capabilities
• Speak at Scientific Events and represent the company in international scientific forums
• Ensure the strategic programme supports business strategy and meets market needs
• Carry out tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Your profile:

• PhD in Chemistry, Chemical Engineering, Materials Sciences, Pharmaceutical Technology or similar scientific field
• Typically requires 12-18 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry. A Ph.D. degree in a relevant scientific field is typically considered equivalent to 4 years of relevant experience.
• Demonstrated experience in the field of continuous tableting, developing novel formulations, establishing pipeline of new products
• Previous experience in both internal and external stakeholder management
• Experience in establishing external collaborations and licensing technologies
• Fluency in English is a requirement
• Computer literate with good working knowledge of the MS Office package
• Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down

Key responsibilities:

• As Subject matter expert, you will be responsible for the technical strategic programme in the field of Inhalation
• Responsible for portfolio of projects within the programme, from ideation to launch including prioritisation, governance, resourcing and overall budget management
• Promotes the scientific excellence and innovation in the field of Inhalation and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
• Lead the development and implementation of the R&D strategy for Inhalation
• Supervise projects within the field of Inhalation, providing technical expertise and support to the project leads ensuring the right networks are developed internally and externally
• Review complex projects within the area to promote innovative approaches leading to the generation of IP (patents or trade secrets)
• Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about Hovione technical competencies and capabilities
• Speak at Scientific Events and represent the company in international scientific forums
• Ensure the strategic programme supports business strategy and meets market needs
• Carry out tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Your profile:

• PhD in Chemistry, Chemical Engineering, Materials Sciences, Pharmaceutical Technology or similar scientific field
• Typically requires 12-18 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry. A Ph.D. degree in a relevant scientific field is typically considered equivalent to 4 years of relevant experience.
• Demonstrated experience in the field of inhalation, developing novel formulations, establishing pipeline of new products
• Previous experience in both internal and external stakeholder management
• Experience in establishing external collaborations and licensing technologies
• Fluency in English is a requirement
• Computer literate with good working knowledge of the MS Office package
• Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down

Key responsibilities:  - Actively contributes to the development and implementation of compnay’s strategy for the area and the standardization of best practices - Supervise projects within the area, proving technical expertise and best practices to the area TMs 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 complex projects within the area to promote innovative approaches that can lead to the generation of IP (patents or trade secrets) - Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about company technical competencies and capabilities - Ensure there is a continuous improvement mindset in the project implementation to enhance productivity, decrease costs and deliver the best service to our customers - Speak at Scientific Events and represent the company in international scientific forums - Address gaps in technical competencies by coaching and developing team members with the area - Lead multiple work fronts and ensure the implementation of best practice improvements within the area - Show business acumen, see the big picture and understand the impact of decisions on the business - Is regarded as a Subject Matter Expert within the company - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of company´s policies, systems and procedures (COPs, HBR, SOPs and others) - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice   Your profile: - PhD in Chemistry, Chemical Engineering, Materials Sciences, Pharmaceutical Technology or similar scientific field - Typically requires 12-18 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry. A Ph.D. degree in a relevant scientific field is typically considered equivalent to 4 years of relevant experience. - Expert in Chemical Engineering, Chemistry, Organic Chemistry and Unit Operations, or of Reaction Engineering, Heat Transfer, Scale-up, Process Safety and Industrial Operations, or of drug product unit operations, solids flow phenomena and process equipment - Knowledge of mathematics, preferably data management, statistics and first principles modeling (preferred) - Fluency in English is a requirement - Computer literate with good working knowledge of the MS Office package - Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down

Key responsibilities:

- Actively contributes to the development and implementation of company’s strategy for the area and the standardization of best practices

- Supervise projects within the area, proving technical expertise and best practices to the area TMs 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 complex projects within the area to promote innovative approaches that can lead to the generation of IP (patents or trade secrets)

- Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about company technical competencies and capabilities

- Ensure there is a continuous improvement mindset in the project implementation to enhance productivity, decrease costs and deliver the best service to our customers

- Speak at Scientific Events and represent the company in international scientific forums

- Address gaps in technical competencies by coaching and developing team members with the area

- Lead multiple work fronts and ensure the implementation of best practice improvements within the area

- Show business acumen, see the big picture and understand the impact of decisions on the business

- Is regarded as a Subject Matter Expert within the company

- Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of company’s policies, systems and procedures (COPs, HBR, SOPs and others)

- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

 

Your profile:

- PhD in Chemistry, Chemical Engineering, Materials Sciences, Pharmaceutical Technology or similar scientific field

- Typically requires 12-18 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry. A Ph.D. degree in a relevant scientific field is typically considered equivalent to 4 years of relevant experience.

- Expert in Chemical Engineering, Chemistry, Organic Chemistry and Unit Operations, or of Reaction Engineering, Heat Transfer, Scale-up, Process Safety and Industrial Operations, or of drug product unit operations, solids flow phenomena and process equipment

- Knowledge of mathematics, preferably data management, statistics and first principles modelling (preferred)

- Fluency in English is a requirement

- Computer literate with good working knowledge of the MS Office package

- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down

Key responsibilities:

• Apply strategic-thinking and forward planning to the area projects and implement the necessary actions to promote faultless execution
• Assure the adequate planning of area activities in line with clients and internal requirements and ensuring the liaison with relevant third parties
• Ensure that all projects are staffed appropriately and that the materials requirements of the area are met to guarantee all area’s responsibilities are met and the group is able to exceed customers’ expectations
• Ensure the information flow between all R&D areas and other relevant stakeholders
• Ensure scientific development activities occur with the right level of guidance and technical know-how
• Propose new technologies and methodologies and the necessary investments and resources taking in account both specific driven project objectives and the group scientific and technical objectives and support in their implementation
• Review and approve the protocols, reports and documentation prepared in the Area
• Ensure the continuous improvement and subsequent implementation of new methodologies that can efficiently support process development
• Promote scientific activities (e. seminars, congress participations, innovation ideas, papers and publications) and innovation within the team and encourage the sharing of knowledge with other teams
• Be part of problem-solving processes as required by the team
• Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
• Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with area strategic objectives
• Monitor area´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures
• Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs
• Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Your profile:

• Masters’ degree in Chemistry, Engineering (e.g. Chemical, Mechanical, Biological), Materials Sciences, Pharmaceutical Technology, or related field
• Typically requires 10 years of relevant experience in Research & Development and/or Operations in the Pharmaceutical Industry and coordinating a team
• Proven leadership experience
• Effective time management skills and the ability to multitask
• Track record of overachieving targets
• Possess extensive knowledge of oral drug product formulation, spray drying and amorphous solid dispersions or pharmaceutical unit Operations,  scale-up, solids flow phenomena and process equipment principles and practices and is able to effectively share them with others
• Good communication skills (verbal and written)
• Skilled at managing complex processes and tools
• Fluency in English is a requirement
• Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down

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

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

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.

Key responsibilities:

• Lead the overall initiation, coordination, implementation and management of international clinical trials at different stages during mission duration
• Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met
• Manage operational and technical aspects of projects including budgeting, timelines and risk management
• Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation
• Manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. You may be involved in the selection process, depending on study status
• Monitor vendor and CROs performance and ensure continuous oversight
• Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required
• Represent clinical operations on multi-function project teams internally and externally, if needed; 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

Your profile:

• Bachelor or Master degree or equivalent in Life Sciences
• Proven track record of 5-7 years of experience as Global Clinical Trial Manager or comparable operating experience in Pharma (sponsor), including experience leading global Phase I & II studies from set-up to close-out
• As Global Clinical Trial Manager, you have worked on Cell Therapy or Radiopharmaceutical studies
• Experience in leading global clinical studies for Oncology studies are an asset
• Experience in pharmacokinetic studies (e.g. DDI, ADME) is an asset
• Experience in Management and Filing of Trial Master File (Veeva Vault knowledge is a plus)
• Customer oriented and strong team-spirit with the ability to foster a collaborative team environment and to work effectively with others in a fast-paced matrix organization
• Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency
• Experience in external audits, an asset
• Strong negotiation skills, scientific knowledge and involvement
• Former experience in contributing to protocols and clinical development plans
• Fluent in English – French is an asset
• Travel: up to maximum 20%

Key responsibilities:

• Lead and manage a team of Clinical Trial Managers, 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 Managers / CTMs, 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 CTM (if applicable/ad hoc)
• Lead multi-disciplinary team (CMC, Drug Supply, Regulatory, Pharmacovigilance, Data Management, Statistics, Clinical Development, etc.) 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.

Your profile:

• 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 or CRO, 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 is 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%)

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

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)

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

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

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

3. 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