Director/Senior Director, Drug Development
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:
- Use strong scientific skills and background to independently plan and execute on drug discovery activities.
- Provide strong knowledge of GPCR biology and various GPCR-mediated diseases, including neuropathic pain.
- Interpret experiment results and solve technical problems.
- Actively challenge the scientific thinking at Trevena by presenting new research, technologies, potential targets, and areas of research.
- Establish and foster professional relationships with KOLs and academic institutions.
- Cultivate scientific culture and generating ideas for new drug discovery programs.
- Conduct nonclinical toxicology, safety pharmacology and DMPK studies.
- Oversee analytical and bioanalytical method development and validation to support GLP nonclinical studies.
- Design and manage nonclinical studies according to applicable regulatory guidelines.
- Write nonclinical study summaries for internal and external communications, including regulatory submissions.
- Work with clinical and CMC colleagues to perform stage-appropriate nonclinical studies.
- 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.
- Provide nonclinical expertise to project teams and to partnering/diligence discussions.
- Participate in meetings with regulatory authorities.
- 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.
- Observes all Trevena policies, SOPs and safety guidelines.
- Other duties, as necessary.
Up to 10% domestic/international travel.
EDUCATION & EXPERIENCE
- BS in pharmaceutical development-related science required, MS or PhD preferred.
- Minimum 10 years experience in drug discovery research and/or development.
- Experience developing drugs that target the central nervous system preferred.
KNOWLEDGE, SKILLS & ABILITIES
- Experience developing novel CNS therapeutics, from drug discovery through clinical development.
- Ability to independently design and execute research project activities.
- Demonstrated project leadership experience in biotechnology/pharmaceutical industry.
- Understanding of good laboratory practice (GLP) and the nonclinical development process.
- Ability to identify and engage KOL’s in multiple scientific/disease indications.
- Experience managing nonclinical activities through academic collaborations and utilization of contract research organizations (CROs).
- Ability to effectively manage an external nonclinical team with high attention to details, completing work within approved budgets and timelines.
- Demonstrated ability to independently solve problems in a rapidly changing environment.
- Experience identifying and interacting with drug development consultants.
- Proven track record of successful IND and/or NDA filings.
- Experience with interdisciplinary development teams.
- Ability to communicate data and results clearly and concisely utilizing strong writing and presentation skills.
- Ability to inspire others to collaborate effectively.
Please fill out the form below to submit your application.