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

Merck Group; Deutschland; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

An innovative firm is seeking an Associate Director for Clinical Pharmacology to lead the Expert Team in developing and executing clinical pharmacology strategies. This strategic role involves close collaboration with cross-functional teams to ensure alignment with clinical development plans. The successful candidate will have a strong background in clinical drug development, a doctorate in a relevant field, and excellent communication skills. Join a dynamic environment where your expertise will drive the success of drug candidates across various therapeutic areas, making a significant impact on patient outcomes.

Qualifikationen

• 3+ years in (Bio)pharmaceutical industry with clinical drug development experience.
• Strong understanding of clinical drug development strategies.

Aufgaben

• Lead the Clinical Pharmacology Expert Team and develop CP strategies.
• Deliver dose and posology decisions through the development phases.

Kenntnisse

Clinical Drug Development

Pharmacokinetics (PK)

Pharmacodynamics (PD)

Model Informed Drug Development (MIDD)

Interpersonal Skills

Communication Skills

Ausbildung

Doctorate degree (PhD, PharmD, or MD)

Jobbeschreibung

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.
• 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.
• Contribute to 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 antibody-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 of 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)