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Clinical Pharmacology Director F/M

Ipsen Innovation (SAS)

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.

Summary / purpose of the position

The Clinical Pharmacology Director is responsible for leading the Clinical Pharmacology program and strategy of assigned programs by:

1. Defining and implementing the Clinical Pharmacology Plan of NCE/NBE* to support the registration dossier;
2. Supporting in licensing of innovative assets into the Ipsen portfolio;
3. Providing scientific and operational support to clinical development studies (Ph1 to Ph4) and clinical pharmacology studies as part of any development program within Ipsen TAUs;
4. Interacting with Health Authorities.

The Clinical Pharmacologist sits on the Early Development team, Asset Team, or other sub-team on a case-by-case basis. *New Chemical Entity/New Biological Entity

• Define and implement Clinical Pharmacology Plan of NCE/NBE to support the registration dossier.
• Provide scientific and operational support to Clinical Pharmacology studies (PK, QT, DDI, etc.) from study concept to reporting according to timelines, budget, operational and quality standards.
• Accountable for Clinical Pharmacology input in study protocol and operational implementation within a clinical study team including study conduct, point of scientific contact for study centers and CSR, in close collaboration with the Clinical Operations lead, Statistician, Pharmacometrician, and MDD.

• Provide expertise for evaluation, acquisition & integration of external opportunities.
• Assess opportunities & develop plans for marketing authorization and risk mitigation.
• Contribute to transition plans and ensure proper asset integration into the portfolio.

• Communicate all relevant information and propose Clinical Pharmacology activities aligned with the development plan.
• Draft and contribute to regulatory documentation related to Clinical Pharmacology, participate in meetings with Regulatory Authorities if needed.
• Lead presentation of results at internal and external meetings; contribute to publications and posters.

• Supervise outsourced data analysis activities to ensure timely, budget-conscious, and quality-compliant analyses.
• Ensure proper documentation for clinical pharmacology tasks and maintain records in eTMF.

• Respect and enforce EHS regulations and procedures.
• Promote EHS culture within teams.
• Participate in safety visits and complete mandatory EHS training.

Education / Certifications:

• Desirable: PhD in pharmaceutical sciences/clinical pharmacology or PharmD, with at least 8 years of industry experience, preferably in oncology and rare disease.
• Minimum: PhD in relevant sciences or PharmD with similar experience; relevant education and experience may be considered.

Experience:

• Strong analytical, problem-solving, and communication skills.
• Experience with GxPs and working with CROs.
• Fluent in English (spoken and written).

• Knowledge of drug development processes and clinical pharmacology data analysis.
• Ability to perform PK analysis and contribute to regulatory documents.
• Strong leadership, organizational, and interpersonal skills.
• Proficiency with IT tools and software.

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In its recruitment process, IPSEN is committed to respecting equal treatment of candidates regardless of gender, age, sexual orientation, ethnicity, skin color, nationality, disability, or union membership.