Director/Senior Director, Drug Development

PURPOSE

Reporting to the Vice President, Scientific Operations, the Director/Senior Director of Drug Development will strategically design and execute nonclinical studies to support compound advancement from early-stage discovery through clinical development. The candidate will independently lead research efforts that support target validation, compound characterization and/or pharmacology as well as contributing both strategically and scientifically to project teams. This role will identify appropriate academic/government collaborators or contract research organizations (CRO), develop protocols, manage the conduct of nonclinical pharmacokinetic, metabolism and toxicology studies. The Director/Senior Director of Drug Development will finalize study reports and prepare study summaries for inclusion in regulatory documents (IND, investigator’s brochure, annual report, NDA, etc.).

Specifically, the Director/Senior Director of Drug Development will:

  1. Use strong scientific skills and background to independently plan and execute on drug discovery activities.
  2. Provide strong knowledge of GPCR biology and various GPCR-mediated diseases, including neuropathic pain.
  3. Interpret experiment results and solve technical problems.
  4. Actively challenge the scientific thinking at Trevena by presenting new research, technologies, potential targets, and areas of research.
  5. Establish and foster professional relationships with KOLs and academic institutions.
  6. Cultivate scientific culture and generating ideas for new drug discovery programs.
  7. Conduct nonclinical toxicology, safety pharmacology and DMPK studies.
  8. Oversee analytical and bioanalytical method development and validation to support GLP nonclinical studies.
  9. Design and manage nonclinical studies according to applicable regulatory guidelines.
  10. Write nonclinical study summaries for internal and external communications, including regulatory submissions.
  11. Work with clinical and CMC colleagues to perform stage-appropriate nonclinical studies.
  12. Assure appropriate characterization, in vitro biology, and in vivo pharmacology of research compounds to allow a smooth transition from R&D to nonclinical and clinical development.
  13. Provide nonclinical expertise to project teams and to partnering/diligence discussions.
  14. Participate in meetings with regulatory authorities.
  15. Raise and clearly communicate critical issues and their impact to the appropriate stakeholders in a manner that results in resolution and allows others to do the same.
  16. Observes all Trevena policies, SOPs and safety guidelines.
  17. Other duties, as necessary.

TRAVEL REQUIREMENTS

Up to 10% domestic/international travel.

EDUCATION & EXPERIENCE

  1. BS in pharmaceutical development-related science required, MS or PhD preferred.
  2. Minimum 10 years experience in drug discovery research and/or development.
  3. Experience developing drugs that target the central nervous system preferred.

KNOWLEDGE, SKILLS & ABILITIES

  1. Experience developing novel CNS therapeutics, from drug discovery through clinical development.
  2. Ability to independently design and execute research project activities.
  3. Demonstrated project leadership experience in biotechnology/pharmaceutical industry.
  4. Understanding of good laboratory practice (GLP) and the nonclinical development process.
  5. Ability to identify and engage KOL’s in multiple scientific/disease indications.
  6. Experience managing nonclinical activities through academic collaborations and utilization of contract research organizations (CROs).
  7. Ability to effectively manage an external nonclinical team with high attention to details, completing work within approved budgets and timelines.
  8. Demonstrated ability to independently solve problems in a rapidly changing environment.
  9. Experience identifying and interacting with drug development consultants.
  10. Proven track record of successful IND and/or NDA filings.
  11. Experience with interdisciplinary development teams.
  12. Ability to communicate data and results clearly and concisely utilizing strong writing and presentation skills.
  13. Ability to inspire others to collaborate effectively.

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc