Senior Director, Clinical Pharmacology
Description
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.
Responsibilities (including, but not limited to):
- 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
Requirements
- 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 familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements
- Demonstrated ability as a scientific and or medical expert in a complex matrix environment
- General familiarity with biostatistics and/or pharmacometrics; expert in navigating scientific literature, interpretation of data, display of data
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
- Ability to work well in a fast paced, innovative and performance driven environment
- Demonstrated ability to integrate scientific rationale, target biology, clinical strategy, and target product profile to develop appropriate translational strategies
- Demonstrated ability to simultaneously work on complex projects requiring an in-depth evaluation of multiple, interdependent factors
- Ability to prioritize responsibilities and meet deadlines
- Ability to self-motivate and work independently
- Attention to detail, experience in monitoring work to assure quality, accuracy and thoroughness
- Outstanding communication skills with the ability to effectively converse with a variety of audiences including team members, cross-functional project teams, project leaders, KOLs and senior management
- Demonstrated ability to think strategically and solve complex scientific problems, as well as ability to work at the strategic and tactical level
- Demonstrated ability to contribute successfully in a multi-disciplinary team environment while serving as a team lead
- Excellent problem-solving abilities with a focus on accomplishing company goals and objectives in a dynamic business environment
- Strong focus and drive to succeed
- Comfortable challenging the status quo and bringing forward innovative solutions
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.), as well PK modeling software (Phoenix, R, or NONMEM).
- Ability to travel up to 20%
- The salary range for this position is commensurate with experience