Pharmacometrician Director

Pharmacometrician Director

Ipsen Pharma

Cambridge, London or Paris

Summary & Purpose of the Position

The Pharmacometrics (PMx) department is at the cutting edge of Model-Informed Drug Development (MIDD), shaping decisions across the drug development continuum - from non-clinical research to post-submission. As Pharmacometrician Director, you will lead the implementation of MIDD strategies across oncology, neurology, and rare disease programs. You will play a pivotal role in integrating quantitative modeling to accelerate the development of innovative therapeutics, including small molecules, antibodies, and antibody-drug conjugates (ADCs).

If you are passionate about quantitative science and innovation, this is your chance to make a tangible difference in drug development. This position requires a recognized subject matter expert in pharmacometrics, capable of guiding multiple programs, influencing strategic decisions, and driving cross-functional collaboration to ensure impactful outcomes.

Main Responsibilities & Technical Competencies

Define and implement Pharmacometrics strategies:

• Lead the development and execution of Pharmacometrics (PMx) plans for New Chemical Entities (NCEs) and New Biological Entities (NBEs) to support regulatory submissions.
• Drive the PMx strategy across non-clinical and clinical projects, contributing to modeling and simulation activities to guide drug development decisions.
• Identify opportunities to leverage Model-Informed Drug Development (MIDD) to optimize study designs and enhance program success.
• Inform drug development strategies to support decision-making and successful approvals.

Contribute to PMx documentation and regulatory submissions:

• Ensure the timely delivery and high quality of PMx documents, including dataset specifications, analysis plans, and reports.
• Collaboratively author and review key documents where PMx is a contributor, such as clinical development plans, pediatric investigational plans, and submission packages.

Communicate PMx insights and influence cross-functional teams:

• Represent the PMx group in project teams and cross-functional initiatives.
• Collaborate with teams across early development, pharmacology, biometry, and clinical operations.
• Participate in internal and external working groups, scientific conferences, and publications to share PMx insights and best practices.

Conduct and oversee hands-on PMx activities:

• Perform or supervise modeling and simulation activities, including population PK/PD, exposure–response, disease progression, and minimal PBPK modeling.
• Support design and optimization of non-clinical and clinical trials using simulation and optimal design methods.
• Develop and implement innovative PMx methodologies to advance program objectives.
• Stay current with emerging PMx approaches and technologies.
• Plan, budget, and manage subcontracted PMx activities, including PK/PD and PBPK studies.

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.

Knowledge & Experience

Knowledge & Experience (essential):

• 6+ years of experience in Pharmacometrics within the pharmaceutical industry, CROs, regulatory agencies, or academia.
• Proficiency in modeling and simulation (Population PK/PD, Translational PK/PD, tumor growth model, Time-to-event model, joint modeling, item-response theory).
• Experience with regulatory submissions (e.g., Module 2.7.2 - Clinical Pharmacology Overview, meeting with regulatory agencies).
• Strong expertise in at least one PMx software (NONMEM or MONOLIX).
• Proficiency in data management, plot generation, and statistical software (R).
• Strong analytical and problem-solving skills.
• Excellent scientific writing, interpersonal communication, and networking skills.
• Attention to detail in a time-sensitive environment.
• Familiarity with good clinical/laboratory practices (GxPs).
• Experience working with CROs.

Knowledge & Experience (preferred):

• Experience in small molecules, Antibodies and ADC.

Education/Certifications (essential):

• PhD, MD, or Master’s degree from an accredited institution in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics, or a related field.
• At least 6 years of experience in the pharmaceutical industry, CRO, regulatory agencies, or academia.

Education/Certifications (preferred):

• Experience in oncology and rare disease.

Language(s) (essential):

• English.