Scientific Director​/Associate Director, Clinical Pharmacology

Work Location:

Billerica, Massachusetts

Shift:  Department:  HC-RD-BQ1 Section 1

Recruiter:  Sarah Ellis This information is for internals only. Please do not share outside of the organization.

Your Role:

The 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 CP Expert Team Lead 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.

Location:

This is a hybrid (3x/week in office) role based in Billerica, MA.

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 onDose 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 functionsPK/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

Who You Are:

Minimum Qualifications:

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

Preferred Qualifications:

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.

Pay Range for this position: $167,The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be…