The Director, Clinical Pharmacology and Pharmacometrics is responsible for providing strategies, plans and deliverables on pharmacology and related pharmacometrics & quantitative analytics, for the advancement of select programs across all stages of drug development. Primary responsibilities include the strategic planning and execution of translational & clinical pharmacology activities, as a core member of program teams, in seamless coordination and collaboration with other internal functions and subject matter experts (SMEs).

The person in this role has a strong knowledge of best practices in Clinical Pharmacology and Pharmacometrics, hands-on experience in designing and executing clinical pharmacology studies and PK/PD modeling plans, and the ability to make data-driven decisions and contributions towards clinical development strategies, clinical trial design strategies, and dosing decisions, based on preclinical, clinical and natural history information. The person in this role works seamlessly with colleagues in the Translational Biomarkers & Pharmacology department and, as a core member of high-paced program teams, with SMEs in platform discovery, preclinical research, clinical development, clinical operations, regulatory, CMC and program management, enabling IND submissions, initiation of clinical development programs, late-stage development, and interactions with Health Authorities.

This role is based in Waltham, MA without the possibility of being a remote role.

Primary Responsibilities Include:

• Provide strategies and plans for integrative clinical pharmacology, quantitative data analytics including PK/PD modeling, and translational biomarkers, in alignment with Regulatory requirements as well as corporate and R&D goals, thereby enabling the advancement of programs across all stages of drug development
• Represent the Translational Biomarkers & Pharmacology department as SME, providing expertise and guidance on pharmacology and quantitative PK/PD to R&D program teams and in close collaboration with Medical, Biometrics, Pharmacovigilance, Preclinical Tox and ADME/DMPK SMEs.
• Identify and manage consultants and vendors to support clinical pharmacology and related activities
• Author high quality regulatory documents
• Accountable for adherence to agreed timelines and budgets to ensure execution of deliverables from Clinical Pharmacology studies and drug development programs
• Collaborate cross functionally with all relevant areas to support corporate objectives

Education and Skills Requirements:

• PhD, PharmD, or equivalent training in Pharmacology, Pharmaceutical Sciences, Engineering, with 10+years of bio/pharmaceutical industry drug development experience in Pharmacology- or Biomarker-related functions
• Strong understanding of Clinical Pharmacology principles, PK/PD modeling and simulation, the drug development process and regulatory guidances, particularly around oligonucleotides and biologics (including antibody-drug conjugates), molecular delivery systems, and rare diseases
• Experience with the preparation of Clinical Pharmacology portions of regulatory documents such as pre-IND, IND, IB, briefing documents, clinical study reports, CTA, and BLA
• Ability to devise innovative dosing strategies in a data-driven manner for novel classes of molecular drug & delivery modalities
• Strong interpersonal and relationship building skills with demonstrated experience to lead and influence within a matrixed environment
• Ability to work and communicate in an open and clear manner, listening effectively and inviting responses and discussions with internal and external partners
• Independent and highly motivated, with the ability to multi-task, drive strategy and execution, in a fast-paced and fluid collaborative environment

Posted On: Tuesday, January 7, 2025