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

The businesses of Merck KGaA, Darmstadt, Germany; Darmstadt; Hybrid; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Director of Clinical Pharmacology to lead a strategic team in developing innovative drug development strategies. This pivotal role involves collaboration across various scientific disciplines, ensuring alignment with clinical development plans, and executing comprehensive pharmacology strategies. Ideal candidates will have a strong background in clinical pharmacology and drug development, with the ability to navigate complex regulatory environments. If you're passionate about advancing drug development and thrive in a collaborative, dynamic setting, this opportunity is perfect for you.

Qualifikationen

• 5+ years in (Bio)pharmaceutical industry with clinical drug development experience.
• Strong understanding of clinical drug development strategies and quality requirements.

Aufgaben

• Lead the Clinical Pharmacology Expert Team and develop MIDD strategies.
• Ensure CP strategy aligns with cross-functional development plans.

Kenntnisse

Clinical Pharmacology

Model Informed Drug Development (MIDD)

Pharmacokinetics (PK)

Pharmacodynamics (PD)

Drug Development Strategies

Regulatory Requirements

Interpersonal Skills

Communication Skills

Ausbildung

Doctorate degree (PhD, PharmD or MD)

Jobbeschreibung

Your role

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 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 CP 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 clinical pharmacology and promote MIDD with internal and external stakeholders
• Provides in-depth CP, PK and PK/PD 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

• 5+ 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, pharmaceutics, pharmacometrics, statistics, engineering or mathematics
• Fluency in English

Preferred Requirements

• Strong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas.
• 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
• have 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-BQ2 Section 2
Job evaluation:AT-level (Expert 4)