Sr./Executive Director, Preclinical Development Team Lead

Frontier Medicines is seeking a passionate and accomplished leader to join us as Senior Director/Executive Director, Preclinical Development Team Lead. This role will be key in advancing Frontier’s non-clinical strategy and overseeing the execution of multiple drug discovery programs to advance our innovative pipeline of “undruggable” targets into the clinic. The ideal candidate will have a successful track record of leading project teams to deliver development candidates through IND, and will demonstrate a unique blend of strategic acumen and leadership skills. The incumbent will work effectively with a cross functional team including DMPK, toxicology, regulatory, CROs, and program management. If you are committed to translating scientific discoveries into drugs that improve patients' lives, and thrive in a dynamic, fast-paced environment, we invite you to join the Frontier team.  

What will you be doing?

• Develop and oversee non-clinical program strategy (including defining key milestones, decision points and timelines, identifying risks and mitigation strategies) and execution (including designing experimental approach, data package generation, and regulatory content) to advance our development candidates (DCs) to IND across the research and non-clinical portfolio,
• Partner effectively with Toxicology, Research, Clinical, Regulatory, Project Management and other functional areas as well as company leadership to effectively progress programs.
• Implement efficient cross-functional processes across disciplines (DMPK, toxicology, bioanalytics, biomarker development, pharmacology) for execution of the non-clinical development strategy from discovery to document generation and filing; serve as a responsible steward of budget and timelines keeping teams accountable for deliverables.
• Establish and maintain effective relationships with CROs, consultants, and internal team members to develop and qualify various analytical and bioanalytical methods. Monitor CRO work in the conduct of in vitro and in vivo studies. Review study protocols and reports, interpret and communicate results. 
• Ensure robust analysis, interpretation and reporting of preclinical data packages generated both internally and with external CROs/collaborators.
• Co-ordinate authorship, review and approval of scientific reports that support regulatory documents including INDs, CTAs, and NDA filings.
• Contribute to a team culture that promotes scientific excellence, integrity and urgency, and encourages innovative thinking and bold new ideas.

What We’re Looking For

• PhD in Pharmacology, Clinical Pharmacology, Pharmaceutical Science, Toxicology or other relevant field with 10+ years of experience in the biopharmaceutical industry
• Strong knowledge of, and experience with, nonclinical small molecule development, drug metabolism, ADME concepts, pharmacokinetics, safety/toxicology, pharmacodynamic and bioanalytical principles
• A track record of success with bringing drug discovery projects to the clinic and prior experience with regulatory submissions (e.g., IND, NDA and/or BLA)
• Ability and interest in leading dynamic, multi-disciplined project teams
• Exceptional influencing skills that demonstrate strong thought partnership and create effective relationships with internal and external stakeholders
• Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment
• Ability to promote a team culture that strives for continuous improvement, ownership, professional growth, and inclusion