Director Jobs

About The Position

Requirements

• 2+ years pharmaceutical industry and/or postdoctoral experience in clinical drug development (5+ years for Scientific Director)
• Doctorate degree (PhD, PharmD or MD) relevant in the related disciplines of clinical pharmacology, pharmaceutics, pharmacometrics, statistics, engineering or mathematics

Nice To Haves

• 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.
• Broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities.

Responsibilities

• 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

Benefits

• health insurance
• paid time off (PTO)
• retirement contributions