Job Opportunities

Head, Clinical Pharmacology & Drug Metabolism and Pharmacokinetics (DMPK)

Location: San Francisco, CA

About the position

Enliven is dedicated to advancing small molecule drug development programs in oncology. The Head of Clinical Pharmacology & Drug Metabolism and Pharmacokinetics (DMPK) will provide hands-on leadership be accountable for the overall strategy for Enliven’s development portfolio from pre-IND to approval, including designing and implementing program specific clinical pharmacology studies, data analysis, internal decision points and external regulatory interactions. The ideal candidate will also have the opportunity to oversee pre-clinical pharmacology, toxicology, pre-clinical ADME and DMPK and work equally closely with the scientific staff and leadership in Biology, Chemistry, to oversee preclinical programs and translational science strategy.

Essential Functions

  • Accountable for the design, execution, analysis and interpretation of clinical pharmacology studies and data, to enable creative and timely regulatory submissions globally that satisfy regulatory expectations and requirements from pre-IND to approval. 
  • Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical, statistics, regulatory, non-clinical ADME, toxicology to support and impact development decisions.
  • Contribute to program strategy, study design, protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation
  • Ensure the integration of nonclinical and early clinical findings with planned clinical programs; secure cross functional alignment and transparent discussion of opportunities and risks, with clear plans to further investigate, optimize, and track throughout development. 
  • Ensure appropriate PK< PD and PK/PD data analyses including population PK, PK/PD modeling and simulation are conducted for each study/program
  • Work closely with research and development teams and provide input into assay development, CRO selection and CRO management
  • Represent nonclinical and clinical pharmacology during meetings and discussions with regulatory authorities
  • Effectively and transparently manage multiple, at times conflicting priorities, and proactively seek creative yet viable solutions to resolve such conflicts. 
  • Appropriately balance the internal infrastructure and capabilities vs. outsourcing, while ensuring systems are in place to safeguard a GxP compliant environment. 
  • Directs and ensures that the activities of the department are in compliance with record management, resource management, vendor management best practices and fosters a culture of continued process improvement.  
  • Maintain an effective network of outside partners, collaborators and service organizations, and work with high-quality CROs that meet the highest standards scientifically and ethically. 
  • Contribute to the overall leadership of Enliven Pharmaceuticals, including being a proactive and accountable member R&D governance committees 
  • Maintain up to date knowledge of regulatory agency nonclinical/clinical pharmacology and toxicology regulations/guidelines, and maintain a command of relevant scientific literature and evaluate implications for internal projects.  
  • Develop and administer budgets, resource plans, and performance objectives

Education, Experience, Skills

  • PhD (or MD) in a drug development-related disciple with 15+ years of experience in the pharmaceutical or biotechnology industry, with 10+ years of direct experience in clinical pharmacology 
  • A broad understanding of drug development as evidenced by a track record of significant contributions to successful patents, INDs, Regulatory Agency interactions, NDAs, drug approvals, and peer reviewed publications. 
  • Global experience is strongly desired. 
  • Proven ability to build and lead an excellent nonclinical development / clinical pharmacology function, ideally with extensive outsourcing components
  • Experience building and managing collaborations with contract research organizations (CROs), consultants, pharmaceutical partners and other outside organizations. 
  • Proven track record of being a strategic thinker and a tactical implementer. 
  • Ability to think critically and solve problems, possesses a quick and analytical mind, is a fast-learner and works well in an organization that places a high value on intellectual capacity. 
  • Excellent written and oral communication skills.  
  • Comfortable in an entrepreneurial organization, wherein all leaders must take a hands-on approach and the environment is fast-paced and challenging.

Interested applicants, please send resume to:

Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.

Enliven Therapeutics does not accept resumes from recruitment agencies for this position. Recruiters, please do not send resumes to Enliven employees or to the company location. Enliven is not responsible for any fees related to unsolicited resumes.