Head of DMPK
Location: Cambridge, MA
We are seeking an expert in drug metabolism and pharmacokinetics to establish a DMPK function, which will provide support for Oncology pre-clinical and clinical development stage projects. The successful candidate will be responsible for the oversight of pre-clinical and development stage ADMET-DMPK strategies in a multidisciplinary team environment. This individual will be a key member of drug discovery and development teams providing PK, in vitro/in vivo drug metabolism and PK/PD modeling and analysis support for small molecule and antibody projects. In addition, this leadership position will maintain and establish strategic alliances for outsourcing, managing and reporting regulatory DMPK programs, studies and other activities to provide appropriate content and documentation for regulatory submissions.
- Provide strategic oversight for DMPK establishing department goals and tactical implementation of plans.
- Oversee quality and performance of all DMPK activities including interactions with alliance partners, CROs and external project support.
- Act as DMPK lead for drug discovery and development stage projects.
- Identify and implement the appropriate assays and technologies relevant to ADME-DMPK characterization in support of drug discovery teams.
- Design and develop approaches for investigative DMPK assessment of small molecule and antibody therapeutics for oncology drug discovery and development projects.
- Oversee all DMPK data analysis, PK/PD modeling &simulation and prediction to provide human dose projections and exposures
- Integrate, interpret and report data to Clinical teams and management.
- Prepare and present internal and external documentation relating to regulatory documents (e.g. IND, CTA, Protocols annual reports and IBs).
- Initiate and facilitate collaboration with DMPK, modeling/simulation and clinical pharmacology consultants as necessary to support internal infrastructure.PhD in Pharmacokinetics, Drug Metabolism or related field with a minimum of 8 years industrial experience in the evaluation of small molecule therapeutics. An excellent understanding of early stage drug discovery and development process for oncology therapeutics.
- A strong understanding of Oncology is required; experience in small molecule therapeutics required, antibody therapeutics is a plus.
- Demonstrated knowledge of global regulatory requirements and expectations for nonclinical DMPK packages to support first-in-human and clinical development studies including thorough knowledge of GLP, GCP, ICH and other applicable guidelines.
- Extensive experience in the outsourcing and external oversight of nonclinical DMPK studies conducted by qualified suppliers.
- Ability to communicate clearly and effectively with project teams, management and CROs.
- Ability to work in a team environment, meet deadlines and prioritize and balance work from multiple groups.
- Independently motivated, detail oriented and good problem solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.