Head, Clinical Pharmacology

Job Title:

Head of Clinical Pharmacology

Division / Function:

R&D/Early Development/Clinical Pharmacology, DMPK & Pharmacometrics

Manager's Job Title:

VP, Head of Clinical Pharmacology, DMPK & Pharmacometrics

Location:

Paris, France or London, UK or Cambridge, US

WHAT - Summary & Purpose of the Position

The Head of Clinical Pharmacology

• leads a team of Clinical Pharmacologist leads, providing strategic direction, leadership, and technical expertise for all aspects of clinical pharmacology studies across the IPSEN portfolio, including small molecules, peptides, and biologics (mAbs, ADCs, proteins), as well as due diligence for external assets.
• drives the strategic vision for clinical pharmacology, ensuring alignment with R&D objectives and advancing innovative methodologies to accelerate drug development and regulatory success.
• mentors and develops clinical pharmacology talent, fostering a culture of scientific excellence, continuous learning, and high performance.
• fosters strong partnerships across Early Development, Clinical Operations, Regulatory Affairs, and external collaborators to ensure seamless integration of clinical pharmacology insights into asset development and lifecycle management.
• acts as Clinical Pharmacology lead for specific projects, accountable for planning and implementing detailed protocol strategies and plans for all clinical pharmacology studies (FIH, PK, QT, DDI, etc.) from study concept to reporting, ensuring delivery according to timelines, budget, operational, and quality standards.
• sits on the Early Development team, Asset Team, or clinical sub-team as appropriate.

WHAT - Main Responsibilities & Technical Competencies

Lead the Clinical Pharmacology Group & Officiate as Lead Clinical Pharmacologist on projects

• Provide strategic leadership and scientific oversight to the Clinical Pharmacology group, ensuring alignment with Ipsen's R&D and Early Development goals.
• Recruit, mentor, and develop a high-performing team of Clinical Pharmacologists, fostering a culture of innovation, collaboration, and continuous learning.
• Define and implement best practices and cutting-edge methodologies for the design and execution of clinical pharmacology studies across modalities (small molecules, peptides, biologics including mAbs, ADCs, proteins).
• Provide expert input into first-in-human strategy and study design, integrating translational insights and model-informed drug development approaches.
• Serve as the Clinical Pharmacology representative on cross-functional project teams, contributing to early development strategy and decision-making.
• Collaborate with internal and external stakeholders to evaluate clinical pharmacology aspects of in-licensing opportunities and external assets.

Plan

• Lead the development of clinical pharmacology study protocols and ensure their operational execution within clinical study teams.
• Oversee the planning and delivery of studies such as SAD, MAD, DDI, HMB, TQT, and Food Effects, ensuring scientific rigor, operational excellence, and regulatory compliance, in close collaboration with the respective Clin Ops lead, Statistician, and MDD on the study.
• The Clinical Pharmacology lead will also work in close collaboration with EDTLs and EI leads to support in licensing of innovative assets into the Ipsen portfolio.

EHS responsibilities

• Respect and enforce applicable EHS regulations and procedures.
• Promote EHS dynamics within teams for the proper functioning of the EHS management system
• Participate in the prevention of accidents at work by carrying out the Managerial Safety Visits (VMS) of its employees
• Ensure the completion of mandatory EHS training by his collaborators

HOW - Behavioural Competencies Required

Drive Vision and Strategy

• Paints a compelling picture of the vision (future status quo) and strategy that motivates others to action.

The role requires strategic direction, leadership, and driving the vision for clinical pharmacology, ensuring alignment with IPSEN's R&D objectives and advancing innovative methodologies.

Drives the strategic vision for clinical pharmacology, ensuring alignment with IPSEN's R&D objectives and advancing innovative methodologies to accelerate drug development and regulatory success.

Provide strategic leadership and scientific oversight to the Clinical Pharmacology group, ensuring alignment with Ipsen's R&D and Early Development goals.

Develops/coaches Talent

• Able to identify and align career goals, and blend organizational objectives into a cohesive development plan for self and team.
• Able to coach
• Provides structured, actionable, regular and directional feedback and acts as a coach to empower people to own their own growth/development.
• Prepares their own succession plans.
• Displays a radically human-centered mindset; puts people first; focuses on doing good.
• Demonstrates ability to build team effectiveness.

The role is responsible for mentoring and developing clinical pharmacology talent, fostering a culture of scientific excellence, continuous learning, and high performance.

Mentors and develops clinical pharmacology talent, fostering a culture of scientific excellence, continuous learning, and high performance.

Recruit, mentor, and develop a high-performing team of Clinical Pharmacologists, fostering a culture of innovation, collaboration, and continuous learning.

Provide expert input into first-in-human strategy and study design, integrating translational insights and model-informed drug development approaches.

Manage Complexity

• Identifies contradictory information/demands/inputs to effectively solve problems.
• Develops and evaluates alternative scenario and solutions.
• Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact.

The position oversees complex clinical pharmacology studies, manages diverse modalities, and ensures delivery according to timelines, budget, operational, and quality standards.

Accountable for planning and implementing detailed protocol strategies and plans for all clinical pharmacology studies (PK, QT, DDI, etc.) from study concept to reporting, ensuring delivery according to timelines, budget, operational, and quality standards.

Oversee the planning and delivery of studies such as SAD, MAD, DDI, HMB, TQT, and Food Effects, ensuring scientific rigor, operational excellence, and regulatory compliance.

Lead the development of clinical pharmacology study protocols and ensure their operational execution within clinical study teams.

Cultivate Innovation

• Questions status-quo and adopt new approaches.
• Has vision, bring ideas and possibilities and turn it into actions.
• Thinks outside the box, reframes problems in different lights.
• Encourages/considers/integrates different perspectives/ideas

The role advances innovative methodologies to accelerate drug development and regulatory success, and fosters a culture of innovation within the team.

Drives the strategic vision for clinical pharmacology, ensuring alignment with IPSEN's R&D objectives and advancing innovative methodologies to accelerate drug development and regulatory success.

Define and implement best practices and cutting-edge methodologies for the design and execution of clinical pharmacology studies across modalities.

Recruit, mentor, and develop a high-performing team of Clinical Pharmacologists, fostering a culture of innovation, collaboration, and continuous learning.

Collaborates

• Collaborates and communicates without boundaries, continuously removes organizational barriers.
• Focuses on continuous improvement; integrates and leverages key learnings, showcases resourcefulness, learning/experimenting at scale, demonstrates strong entrepreneurial behaviors and mindset.

The role requires fostering strong partnerships across Early Development, Clinical Operations, Regulatory Affairs, and external collaborators to ensure seamless integration of clinical pharmacology insights into asset development and lifecycle management.

Fosters strong partnerships across Early Development, Clinical Operations, Regulatory Affairs, and external collaborators to ensure seamless integration of clinical pharmacology insights into asset development and lifecycle management.

Serve as the Clinical Pharmacology representative on cross-functional project teams, contributing to early development strategy and decision-making.

Collaborate with internal and external stakeholders to evaluate clinical pharmacology aspects of in-licensing opportunities and external assets.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Extensive Industry Expertise: 10+ years in pharmaceutical/biotech within drug discovery, clinical trials, and drug development, with a proven record of leadership in cross-functional environments.
• Clinical Pharmacology Proficiency: Hands-on experience with SAD, MAD, DDI, HMB, TQT, BE, and Food Effect studies.
• Phase I Leadership: Demonstrated success in managing multiple Phase I clinical studies concurrently.
• Comprehensive Process Knowledge: Strong understanding of clinical trial management, data management, and the end-to-end drug development process.
• Operational Excellence: Skilled in project management, including planning, prioritization, problem-solving, and organization; adept at handling multiple priorities.
• Influential Interpersonal Skills: Proven ability to build strong relationships and influence stakeholders across diverse functions and cultures.
• Attention to Detail & Communication: Exceptional accuracy, clear and direct communication, and cultural sensitivity.
• Leadership & Management: Strong managerial capability with a recognized leadership profile.
• Strategic Vision: Ability to maintain a big-picture perspective while managing critical details.
• Professional Representation: Consistently represents the organization with professionalism and integrity.
• Proactive & Positive: Self-directed, flexible, and solution-oriented with a positive attitude.
• Commitment to Growth: Passionate about continuous learning and developing self and others.

Education / Certifications (essential):

• MD or PhD or PharmD with a minimum of 10 years in Clinical Pharmacology & DMPK experience in Pharma and / or biotech.

Language(s) (essential):

• English: Excellent written, verbal, and interpersonal communication skills.