Position Summary:
The Director, Clinical Science, will provide management and support for Travereβs ongoing and future nephrology development and life-cycle activities for clinical programs. Work with cross-functional teams on clinical trial design and execution, and related translational/clinical data analyses, interpretation, and presentation while ensuring Good Clinical Practices (GCPs) are followed.
Responsibilities:
- Assist in design and implementation of clinical studies (including human pharmacology studies) and data analyses.
- Assist in reporting clinical trial data for safety and efficacy.
- Ensure GCPs are followed.
- Lead/author clinical and data analysis reports, slide presentations, clinicaltrial.gov summaries, etc. with clinical development/pharmacology teams, collaborators, and statistical staff.
- Contribute to clinical/scientific/mechanism-of-action sections of INDs, NDAs, and BLAs (protocols, SAPs, mock TFLs, investigator brochures, medical reports, efficacy/safety summaries, scientific rationales, benefit/risk ratios, regulatory briefing books, and regulator information requests).
- Establish and maintain relationships with alliance partners, external companies, investigators, and key opinion leaders.
- Prepare manuscripts and present at scientific meetings.
Education/Experience Requirements:
- PhD, PharmD, and/or MD in a related life science discipline (required); rare disease and/or nephrology experience (preferred).
- 6β8+ years pharmaceutical industry experience.
- Clinical trial/study experience (required); human pharmacology studies (preferred).
- Experience contributing to INDs/NDAs/BLAs and regulatory information requests (strongly preferred).
Additional Skills/Experience:
- Ability to review/interpret/present complex scientific data.
- Strong organization, multitasking, prioritization, and attention to detail.
- Strong verbal and written communication; inclusive, collaborative teamwork.
- Flexibility to adapt to changing project plans; domestic/international travel up to 15%.
Application instructions:
- Apply on an ongoing basis until a candidate is selected for the position.