Work Location: Billerica, Massachusetts Shift: Department: HC-RD-BQ3 Section 3 Recruiter: Sarah Ellis
This information is for internals only. Please do not share outside of the organization.
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
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