Pharmacometrician Director

Ipsen Pharma

Boulogne, France

Job Description:

The Pharmacometrics (PMx) department is at the forefront of driving Model-Informed Drug Development (MIDD) to support drug development and regulatory decisions from non-clinical stages through to post-submission. The Pharmacometrician Director will be responsible for implementing the MIDD strategy across various programs, particularly in oncology, neurology, and rare disease therapeutic areas. This role will be pivotal in integrating quantitative methods to advance the development of innovative therapeutics, including small molecules, antibodies, and antibody-drug conjugates (ADC). The Director will serve as a subject matter expert in key pharmacometrics areas, proactively supporting multiple programs.

Define and implement the Pharmacometrics Plan for New Chemical Entities (NCE) and New Biological Entities (NBE) to support registration dossiers:

Develop the PMx strategy and contribute to modeling and simulation activities for non-clinical and clinical development projects.
Identify opportunities for MIDD to enhance project support.
Optimize study designs and inform drug development strategies for decision-making and successful approvals.

Performing (hands-on) and/or monitoring (oversight) Pharmacometrics (PMx) activities from non-clinical to clinical drug development stage:

Conduct modeling and simulation activities, including but not limited to population pharmacokinetics/pharmacodynamics (PK/PD), exposure/response, disease progression modeling, and minimal PBPK.
Support the design of non-clinical and clinical trials using simulation and/or optimal design methods.
Develop, implement, and promote innovative PMx methodologies and approaches.
Stay updated with new PMx approaches.
Plan, budget, and execute subcontracted PMx activities (PK/PD and/or PBPK).

Contributing to all PMx documentations:

Ensure the timely delivery and quality of PMx documents (e.g., dataset specifications, analysis plans, and reports).
Collaboratively write and review key documents where PMx is a co-author (e.g., clinical development plans, pediatric investigational plans, submission documents).

Communicating on PMx results and how PMx could support all drug development:

Represent the PMx group in project teams.
Interact with cross-functional teams (e.g., early development, pharmacology, biometry).
Participate in internal and external initiatives/working groups.
Conduct external presentations and contribute to publications.

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, abilities & experience

Education/Certifications:

PhD, MD, or Master’s degree from an accredited institution in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics, or a related field.

Minimum requirements/Education (minimum/desirable):

Desirable: PhD in Pharmacometrics, Mathematics, or Statistics with at least 7 years’ experience in the industry, preferably in oncology and rare diseases.
Minimum: PhD, MD, or Master’s Degree with at least 7 years of experience in the pharmaceutical industry, CRO, regulatory agencies, or academia.

An equivalent combination of relevant education and applicable job experience may be considered.

Experience:

7+ 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).
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.

Languages:

English.

Key Technical Competencies Required:

Proficiency in applying PMx software (e.g., NONMEM, Monolix, R).
Proficient knowledge in clinical pharmacology, clinical drug development, MIDD and regulatory guidelines.
Good communication skills.

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