Associate Director, Clinical Pharmacology (all genders) - full-time/part-time possible

Your role: Associate Director, Clinical Pharmacology position in Quantitative Pharmacology within the broader Clinical Measurement Sciences organization is a strategic, scientific, and cross-functional role, leading the Clinical Pharmacology (CP) Expert Team, responsible for developing and executing clinical pharmacology and Model Informed Drug Development (MIDD) strategies from the early to late-stage clinical development. This role represents the CP Expert Team to the global cross-functional drug discovery and development project teams, in close collaboration with colleagues in Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization.

The Associate Director, Clinical Pharmacology provides strong leadership for integrating individual functional contributions, developing clinical pharmacology strategy in alignment with the overall clinical development plan, and executing the program strategy/plan. The scope includes programs from exploratory development (ED) through life cycle management, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas.

Key Accountabilities:

• Ensures that clinical pharmacology strategy is developed, aligned (with cross-functional development plans), endorsed and executed to support the indication, patient population, and phase of development while taking into account the competitive landscape.
• Represent and promote clinical pharmacology & MIDD strategy with internal and external stakeholders.
• Provides in-depth CP, PK/PD and MIDD advice and expertise and lead clinical pharmacology expert team and deliver on.
• Dose and posology decisions, from FIH starting dose through submission and beyond.
• Fit-for-purpose CP package including dose, dose regimen, and adjustment for specific conditions and specific populations, exposure-QTc assessment and immunogenicity assessment in collaboration with other function lines at appropriate stages of development.
• Develop and execute MIDD strategies/plans in collaboration with pharmacometrics and other functions.
• PK/PD data analysis, interpretation, and presentation.
• Related sections of major clinical and regulatory documents (e.g. clinical protocols, IBs, CTDs, INDs, NDAs, IMPDs, briefing books).
• Contribute to due diligence projects, if needed.

Location: Hybrid preferred, Remote possible with travel as required.

Who you are:

Minimum Requirements:

• 3+ years (Bio)pharmaceutical industry and/or postdoctoral experiences with clinical drug development experience.
• Doctorate degree (PhD, PharmD or MD) relevant in the related disciplines of clinical pharmacology, pharmacometrics, pharmaceutics, statistics, engineering or mathematics.
• Fluency in English.

Preferred Requirement:

• Strong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas. Experience supporting large molecules, including anti-body drug conjugates and bsAB is preferred.
• Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc.
• Excellent knowledge of regulatory requirements and submission across the main regions.
• Good understanding about translational sciences such as quantitative pharmacology, safety and biomarkers.
• Clear evidence of ability to adapt to changing business needs by prioritizing multiple tasks.
• General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus.
• Hands on modeling expertise is a plus.
• Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment.
• Demonstrated ability for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results.
• Strong presentation, communication, and organization skills. Ability to communicate technical results to stakeholders.
• A broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities.

Department: HC-RD-BQ3 Section 3
Job evaluation: AT-level 3 (Expert)

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