Pharmacometrician Director

**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 mínimal 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**
- Proficient knowledge in clinical pharmacology, clinical drug development, MIDD and regulatory guidelines.
- Good communication skills.

**#LI-Hybrid**

LI-MC1