Senior Director, Clinical Pharmacology

Senior Director, Clinical Pharmacology

Reporting to the SVP of Research, the Senior Director, Clinical Pharmacology will drive all aspects of the translational strategy, including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and biodistribution studies, and will be accountable for delivering key translational milestones from candidate selection to BLA.

This role may be based in their Waltham, MA or Boulder, CO office. Their office-based employees are required to work in the office three (3) days a week.

• Scientific oversight for translational BLA and IND enabling studies, including exploratory and GLP PK/TK studies, PD and biomarker development, biodistribution studies, and development of reagents and assays for Anti-Drug Antibody (ADA) assessment
• Ensure compliance with regulatory requirements and industry standards for translational and clinical pharmacology related research activities
• Mentor and develop a high-performing translational science team, fostering a culture of innovation and scientific rigor
• Manage CROs and translational scientists that will be interfacing with Research and Development groups as new therapies are advanced
• Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of non-clinical data to support clinical programs and regulatory applications
• Author and review PK, TK, PD, ADA and associated translational study reports in support of regulatory submissions
• Closely collaborate with clinical development to conduct translational components of planned clinical studies
• Contribute to the design execution of program translational strategies integrating both disease and pathway approaches
• Support execution of early and late clinical trials through BLA submission
• Responsible for the strategic planning, authoring, and review of the translational biology components of regulatory documents, scientific data and publications
• Identify significant issues and risks that may impact overall project plans and initiate contingency plans as appropriate
• Contribute to departmental resource planning, budgeting and timeline setting to meet company needs
• Manage CROs conducting translational studies
• Contribute to scientific and clinical interface with key opinion leaders (KOL), facilitating KOL advocacy development
• May provide line management, oversight and coaching to more junior research/clinical staff
• Represent Research and Translational Science for project teams when presenting project and governance meetings
• Lead or participate in cross-functional working groups such as scientific and safety review boards
• Identify and collaborate with academic investigators to optimize the translational strategy and plans for programs
• Responsible for presentation of results and updates of projects at department, project, corporate and scientific meetings

• Requires a PhD degree with a minimum of 12+ years of combined academic and biotechnology or pharmaceutical experience in Clinical Research, Clinical Pharmacology, and/or Translational Sciences, including experience with therapeutic antibodies
• Prior experience in translational science with in-depth knowledge of PK, TK, and PD principles, biomarker development, and biodistribution studies, as well as a significant publication track record supporting this experience
• Deep understanding of and direct clinical experience in immunology, inflammation, and/or endocrinology, in both early and late stages of development
• Hands on experience with modeling and simulation based approaches, including population based PK modeling, exposure response modeling, and model based dose selection.
• Strong understanding of the regulatory requirements for translational research, drug development and submission activities
• Broad and deep understanding of approved and investigational therapies for these disease areas
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• Prior industry experience in the preparation of clinical protocols, study reports, IND, IB, BLA/CTD documents
• Knowledge of GCPs, ICH guidelines and FDA regulations and…