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• Audit & CAPA process owner
• On behalf of the Head of Quality, act as business owner for “Audit & CAPA System”: single point of contact to adequately support the Quality & Business representatives with regards to system related questions.
• Ensure the risk-based audit strategy is properly applied, in close collaboration with the GxP Quality Leads and the Business Partners.
• Create & maintain global GxP audit programs (in line with business priorities and timelines) materialized by means of a Master Audit Plan.
• In line with the outsourced audit model, select qualified auditors to timely execute the agreed Master Audit Plan covering 3rd parties, systems, processes, studies, documents, etc… to adequately assess compliance with DPI Procedural Documents and applicable regulations.
• Manage all audit activities starting from audit planning, preparing, execution up to delivering final report.
• Contribute to preparation and conduct activities of Regulatory Authority Inspections.
• Work with GxP Quality Lead in view of adequate and timely CAPA development.
• Oversee / Manage Quality Coordinator to populate the Audit / CAPA system as per Audit / CAPA process requirements.
• Develop meaningful Audit / CAPA metrics allowing proper oversight / follow-up by business representatives (owners & department heads).
• Generate Audit / CAPA metrics to indicate areas for improvement and to drive continuous improvement initiatives.

• University degree: Pharmacist Diploma, PhD, master’s in science
• 5 to 8 years’ experience in managing quality assurance within the pharmaceutical industry and/or Biotech companies
• Minimum 3 years’ experience with GxP Audits
• Minimum 3 years ‘experience in managing tracking systems such as CAPAs database resulting from GxP audits (ex for GCP: CROs, TMF, Investigational Sites and CSR) as well as deviations, changes tracking systems
• Solid knowledge of GxP
• Good practical experience in using validated electronic quality systems tools (TrackWise, Veeva, Ennov, etc)
• 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

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

• 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
• Experience in Prostate Cancer
• 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: 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

Key responsibilities:

Clinical development strategy

• Provides the strategic direction and clinical development plans (definition and updates).
• Is a permanent member of Core team, leader of the clinical sub-team and depending on the program, may also be a member of study team.
• Provide medical/clinical expertise to Core Team to support the development and Launch of the product.
• Assist the Program Leader for drawing up the project strategy, including the search of new indications.
• Is responsible for clinical input in both internal and regulatory project documents
• Contribute to the review of available data and competitive environment for the product(s). Maintain up to date awareness of all-important advances within a given disease area through scientific literature, attendance at critical meetings and relationships with Key Opinion Leaders (KOLs).
• Establish and maintain communications with prominent clinical investigators in field of expertise. Liaise with internal and external medical community to follow developments within area of expertise.
• Set-up and manage Advisory Boards.
• Frequent involvement in Business Development activities.
• Represent the company clinical perspective in meetings with partners. Involvement on due diligence activities.
• Contributor to portfolio decisions.

Develop clinical trial protocol

• Develop a well thought, and medically solid clinical trial synopsis aligned with the clinical development strategy.
• Develops medical content for protocol and amendments.
• Support clinical operations team to the selection of investigators/sites to run clinical trials.
• Support regulatory team for successful submission of protocol to regulatory authorities.

Medical monitoring of clinical trials

• Serve as a trial level physician and medical monitor for clinical studies.
• Leads dose-escalation meetings.
• Reviews emerging clinical data regularly.
• Managing and oversee the medical monitoring teams of CROs.
• Provide consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators.
• Work in close collaboration with the pharmacovigilance team to ensure adequate overview of the safety signals in the ongoing trials.
• Interpretation of clinical trials results and contribute to clinical development strategy
• Work in close collaboration with the data management and statistics team to ensure proper analysis of clinical trial results.
• Writing of medical section in investigator brochure and other regulatory documents.
• Contributing to writing clinical study report.
• Contributing to publications, data presentation at scientific meetings, and manuscript writing.

Your profile:

Essential:

• Graduate of a recognized school of medicine with an M.D. degree or equivalent with more than 5 years’ experience pharma experience (including in big pharma) this time spent should not include consulting or academia and consulting or academia should not be most recent job.
• Board Certification, Eligibility, or fellowship training in Oncology is required.
• Must have experience in clinical strategy in developing molecules from with experience in early phase clinical studies especially with monoclonal antibodies.
• Demonstrated experience in clinical report writing and publishing.
• Established understanding of pharmacokinetic and pharmacodynamic activities, including biomarkers and pre-clinical studies.
• Should have a strong scientific understanding and the importance in clinical studies.

Desirable:

• Specialty training in Immuno-Oncology, Tumor Immunology, or Immunotherapy.

Technical Competencies

Essential:

• Experience in medical monitoring of phase I/II clinical studies in industry, CRO or academic setting.
• Experience in protocol writing and preparation of submission to regulatory authorities.
• Experience in trial data analysis, interpretation, reporting and presentation (oral presentation, posters, publications).
• The applicant must be able to read, write and speak English.

Desirable:

• Experience in communication with FDA/EMA (e.g. cooperation on an industry sponsored phase 3 trial).
• Previous participation or coordination of advisory boards.
• Training in statistics or clinical trial methodology.

Additional Skills/ Behaviors

• Highly motivated, dynamic physicians with aspiration to evolve and develop in the clinical development space.
• Strong interpersonal, presentation, and excellent written and verbal communication skills.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Develops technical and/or business solutions to complex problems.
• Demonstrated ability in decision-making, influencing, leadership, and affecting change by using a collaborative approach.
• Results orientated work ethic and a positive, can-do attitude.
• Strong organizational and time management skills.
• Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Works on complex problems where analysis of situations or data requires an in[1]depth evaluation of various factors.
• Works on abstract problems across functional areas of the business.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Comfortable challenging the status quo and bringing forward innovative solutions.
• Ability to build strong partnerships and drive role clarity across cross-functional teams as well as with external organizations.
• Highly motivated, self-driven and dependable.
• Willing and able to be “hands on” and willing to “roll-up sleeves” and delve into details as needed.
• Ensures budgets and schedules meet corporate requirements.
• Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.

• 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’s 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

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

• Act as a strategic driver to build and implement a sustainable transversal QMS Procedural Document (ProcDoc) / Training Framework driving the day-to-day GxP development activities
• Evaluate operations from a strategic level to ensure that the QMS consistently meet quality and regulatory requirements from a Procedural Document and Training perspective
• Take a lead role in the transversal QMS Procedural Document & Training Governance ensuring harmonization, efficiencies and simplification where appropriate
• In collaboration with Business stakeholders (incl. senior leaders / process owners), develop and implement streamlined processes / procedural documents compliant with regulatory, industry, and internal quality standards
• Drive and ensure continuous alignment with QMS ProcDoc / Training principles and ways of working across the different functional areas through engaging with key stakeholders, functional teams, and Process Owners
• Provide oversight for the development and maintenance of the Quality Management System and related electronic systems, processes and procedures that ensure compliance with internal and external standards
• Coach and lead Business stakeholders and Quality representatives by providing leadership, expert advice, support and management for translating QMS ProcDoc & Training strategy into operations
• Foster a change management culture to facilitate adoption and usage of new ways of working.  Act as a “Change Agent” to drive the culture of process improvement throughout the organization
• Management and reporting of quality key performance indicators related Procedural Document and Training Management

Your profile:

• At least 15 years ‘experience in Pharma Industry, with at least 10 years in QA and/or QMS roles
• Master’s degree in Science
• Expertise in Quality Management Systems in a regulated, agile, mid-size biopharmaceutical company; in transversal GXP (preferably GCP) Quality Management System and related operations
• Ability to be a strategical thinker and be a driver to bring efficiencies and simplifications in daily activities
• Having demonstrated the ability to drive significant changes in a Quality Management organization
• Experience in strategic partnering with senior leaders and quality representatives
• A comprehensive working knowledge of data integrity and risk management (risk assessment and risk mitigation)
• A good and thorough understanding of current regulatory requirements.
• Ability to interpret current regulations and requirements is essential
• Excellent verbal and written communication and interpersonal skills
• Excellent presentation skills and ability to present content in front of senior management
• Rigor, flexibility, adaptability, and organization
• Pragmatism focused on efficiency and continuous improvement
• Technical skills in view of system / application / software related activities

Key responsibilities:

• Act as a strategic driver to evaluate, optimize and implement the pro-active, fit-for-purpose and risk-based Clinical Quality Strategy ensuring compliance during the day-to-day clinical drug development activities
• Drive the quality culture and create quality awareness throughout the clinical development organization
• Drive effective planning/project management of Clinical Development Quality activities across DPI portfolio
• Lead/manage a team of Clinical Development Quality Leads ensuring proper risk-based quality support at a project level
• Allocate dedicated compliance resources to adequately support the respective Clinical Development activities
• Establish & monitor operational quality objectives of Clinical Development Quality Leads (applying cascading mechanism supporting the departmental Quality and DLT Objectives) and ensure timely Quality Plan development and execution in line with business/project timelines
• Coach and lead Quality representatives and Business stakeholders by providing leadership, expert advice, support and management for translating the Quality strategy into operations
• Contribute to preferred CRO/Vendor selection and qualification process, assess relevant CROs procedures during selection process
• Provide clinical development quality oversight and contribute / participate during CRO/Vendor Governance meetings
• Build collaborative working relationships with business stakeholders (including senior leaders) and ensure adequate communication within the compound-specific teams and cross-functional Quality peers
• Drive and ensure continuous alignment on the clinical development quality ways of working across the different projects/clinical trials through engaging with key stakeholders and functional teams
• Oversee and/or contribute to compound-specific Regulatory Authority Inspections / Due Diligence Activities
• Ensure adequate Audit / CAPA support of Clinical Development Quality Leads, by assisting the DPI business stakeholders to ensure proper CAPA formulation and follow-up
• Might act as Clinical Development Quality Lead of a specific project or as back-up if required

Your profile:

• At least 15 years’ experience in an agile, mid-size biopharmaceutical company, with at least 10 years in Clinical Quality
• Master’s degree in Science
• Ability to be a strategical thinker and be a driver to bring efficiencies and simplifications in daily activities
• Having demonstrated the ability to drive significant changes in a Clinical Quality Management organization
• Experience in strategic partnering with senior leaders and quality representatives
• A comprehensive working knowledge of data integrity and risk management (risk assessment and risk mitigation)
• Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities. Ability to make timely and appropriate decisions as related to the GCP expert and client area
• Capability to quickly analyze problems, communication options and take appropriate action for resolution
• Demonstrates consistent judgement under usual business conditions. Involves others in decision-making processes as appropriate
• Effective cross-functional and cross-cultural skills
• Global business thinking within GCP expert & client area
• A good and thorough understanding of current regulatory requirements.
• Ability to interpret current regulations and requirements is essential
• Excellent verbal and written communication and interpersonal skills
• Excellent presentation skills and ability to present content in front of senior management
• Rigor, flexibility, adaptability, and organization
• Pragmatism focused on efficiency and continuous improvement
• Technical skills in view of system / application / software related activities

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

• 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

• 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 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 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

• 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 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%).