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

Merck Gruppe; Darmstadt; Hybrid; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A forward-thinking company is seeking an Associate Director in Clinical Pharmacology to lead a dynamic team focused on innovative drug development strategies. This strategic role involves collaborating with cross-functional teams to develop and execute clinical pharmacology strategies that support drug discovery and development. You will be at the forefront of integrating pharmacological insights into clinical programs, ensuring alignment with regulatory standards and contributing to the success of various therapeutic areas. If you have a strong background in clinical pharmacology and a passion for advancing drug development, this is an exciting opportunity to make a significant impact in the field.

Qualifikationen

• 3+ years in (Bio)pharmaceutical industry with clinical drug development experience.
• Doctorate degree in clinical pharmacology, pharmacometrics, or related fields.

Aufgaben

• Lead the Clinical Pharmacology Expert Team and develop MIDD strategies.
• Ensure alignment of clinical pharmacology strategy with development plans.

Kenntnisse

Clinical Pharmacology

Pharmacokinetics/Pharmacodynamics (PK/PD)

Model Informed Drug Development (MIDD)

Regulatory Requirements

Interpersonal Skills

Presentation Skills

Collaboration 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 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)