Vice President, Clinical Development
Tango Therapeutics
5 hours ago
Remote friendly (Boston, MA)
United States
$311,200 - $466,800 USD yearly
Clinical Research and Development
Vice President, Clinical Development (PRMT5)
Responsibilities
- Drive pivotal Phase III programs for TNG462 by leading protocol development, amendments, and operational execution.
- Partner with the Head of Clinical Development on strategy and key decisions; serve as the clinical/scientific voice for the program.
- Collaborate cross-functionally with Clinical Operations, Regulatory, Medical Affairs, Biostatistics, and others.
- Partner with Medical Affairs on publications, abstracts, and investigator meetings.
- Represent Clinical Development in industry partnerships.
- Design and initiate study protocols and amendments in compliance with GCP/ICH and regulatory requirements.
- Directly manage clinical scientists supporting the PRMT5 program; mentor and develop emerging clinical leaders.
- Provide strategic input into regulatory meeting planning and slide deck development.
- Lead authorship and oversight of regulatory documents (protocols, INDs, briefing documents, responses to health authority questions).
- Support development and compilation of regulatory filings (INDs, CTAs, NDAs).
- Partner with Project Management on clinical governance agendas and cross-functional alignment.
- Establish and drive operational improvement initiatives; support patient recruitment and Principal Investigator relationships.
- Monitor protocol adherence and ensure quality standards across program activities.
- Build relationships with investigators, thought leaders, and trial sites; act as liaison to clinical investigators.
- Represent PRMT5 clinical development at conferences and investigator meetings; review/co-author medical publications from trial results.
What You Bring
Required Qualifications
- MD with board certification or eligibility in medical oncology or hematology-oncology.
- 15+ years of oncology clinical development experience in biotech/pharma, including 5+ years in late-stage (Phase 2/3).
- Hands-on experience designing, executing, and reporting oncology clinical trials for small molecule targeted agents and/or immunological therapies.
- Direct experience with IND filings required.
- Demonstrated experience leading global clinical programs from protocol design through regulatory submission.
- Strong scientific writing skills; track record authoring regulatory documents.
- Experience managing and mentoring clinical development teams.
- Deep understanding of ICH-GCP, FDA regulations, and global regulatory requirements.
- Strong leadership, people management, and communication/presentation skills; flexible, creative, optimistic, and resourceful.
Preferred Qualifications
- Experience with targeted oncology therapies or precision medicine approaches.
- Phase 3 and NDA/MAA filing/approval experience.
- Experience with novel mechanism agents; prior biotech environment experience.
- Experience with pharmaceutical industry partnerships/collaborations.
- Creative problem-solving skills to identify and implement methods and evaluation criteria.
Salary Range
- $311,200—$466,800 USD
Responsibilities
- Drive pivotal Phase III programs for TNG462 by leading protocol development, amendments, and operational execution.
- Partner with the Head of Clinical Development on strategy and key decisions; serve as the clinical/scientific voice for the program.
- Collaborate cross-functionally with Clinical Operations, Regulatory, Medical Affairs, Biostatistics, and others.
- Partner with Medical Affairs on publications, abstracts, and investigator meetings.
- Represent Clinical Development in industry partnerships.
- Design and initiate study protocols and amendments in compliance with GCP/ICH and regulatory requirements.
- Directly manage clinical scientists supporting the PRMT5 program; mentor and develop emerging clinical leaders.
- Provide strategic input into regulatory meeting planning and slide deck development.
- Lead authorship and oversight of regulatory documents (protocols, INDs, briefing documents, responses to health authority questions).
- Support development and compilation of regulatory filings (INDs, CTAs, NDAs).
- Partner with Project Management on clinical governance agendas and cross-functional alignment.
- Establish and drive operational improvement initiatives; support patient recruitment and Principal Investigator relationships.
- Monitor protocol adherence and ensure quality standards across program activities.
- Build relationships with investigators, thought leaders, and trial sites; act as liaison to clinical investigators.
- Represent PRMT5 clinical development at conferences and investigator meetings; review/co-author medical publications from trial results.
What You Bring
Required Qualifications
- MD with board certification or eligibility in medical oncology or hematology-oncology.
- 15+ years of oncology clinical development experience in biotech/pharma, including 5+ years in late-stage (Phase 2/3).
- Hands-on experience designing, executing, and reporting oncology clinical trials for small molecule targeted agents and/or immunological therapies.
- Direct experience with IND filings required.
- Demonstrated experience leading global clinical programs from protocol design through regulatory submission.
- Strong scientific writing skills; track record authoring regulatory documents.
- Experience managing and mentoring clinical development teams.
- Deep understanding of ICH-GCP, FDA regulations, and global regulatory requirements.
- Strong leadership, people management, and communication/presentation skills; flexible, creative, optimistic, and resourceful.
Preferred Qualifications
- Experience with targeted oncology therapies or precision medicine approaches.
- Phase 3 and NDA/MAA filing/approval experience.
- Experience with novel mechanism agents; prior biotech environment experience.
- Experience with pharmaceutical industry partnerships/collaborations.
- Creative problem-solving skills to identify and implement methods and evaluation criteria.
Salary Range
- $311,200—$466,800 USD