Pharmacometrician Director H/F

Title:

Pharmacometrician Director H/F

Company:

Ipsen Innovation (SAS)

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

WHAT - 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.

WHAT - Main Responsibilities & Technical Competencies

1. 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.

2. 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.

3. 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.

4. 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.

5. 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

HOW - 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

The annual base salary range for this position is $177,000-$259,600

This job is eligible to participate in our short-term incentives program. At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.