Director, Clinical Pharmacology

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United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

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

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html