Vice President, Clinical Development

Job ID
2018-1126
Category
Clinical Development
Job Location
US-MA-Cambridge

Company Summary

The Vice President of Clinical Development will oversee all global Clinical programs at Jounce. As the Clinical Development Lead, you will play a key leadership role as Jounce evolves as a clinical stage biotech company. This role will actively participate in and supervise the clinical development team in the design and execution of the clinical development strategy for JTX-2011 (ICOS agonist in Phase 2), JTX-4014 (PD-1 inhibitor with IND in 2018), the lead macrophage program (in IND enabling studies), and provide clinical leadership to discovery teams on other programs as they advance towards and enter the clinic. This is a high impact, highly influential role that reports directly to Jounce’s Chief Medical Officer.

Role / Responsibilities

  • Build and lead a team of clinical development professionals who embrace the Jounce values of Patients, Teamwork, Great Science, Integrity, Empowerment, and Fun.
  • Develop and implement best in class clinical development practices and procedures commensurate with the stage of development of Jounce clinical programs.
  • Oversee development of protocols, and cooperate in the development of other necessary documents for clinical studies, providing expert medical input throughout.
  • Provide expert input at meetings and interactions with health authorities and in response to questions posed by health authorities worldwide.
  • Provide medical and drug development expertise in the design and implementation of clinical development strategies and global clinical development plans. Responsible for collaborating and driving implementation of the clinical program through cross-functional teams.
  • Represent medical for regulatory interactions, investigator and expert advisory board meetings, external professional societies, seminars, and conventions.
  • Write and/or review clinical sections of clinical/statistical reports, including investigator’s brochures, IMPD, INDs, Briefing Packages, BLA, and other regulatory submissions.
  • Review and interpret clinical study results for strategic decisions, publications, and international regulatory filings.
  • Communicate internally and externally on clinical trial design and results

Qualifications

  • MD or MD/PhD with board certification in medical oncology
  • 8+ years industry experience in designing and executing oncology clinical trials from Phase 1 through Phase 3, with experience in immuno-oncology trials preferred
  • Prior experience in managing clinical trials for biomarker-driven cancer therapies is a plus
  • Experience in leading teams in a fast-paced, cross-functional environment
  • Experience in protocol development and design, including understanding of the strengths and weaknesses of study design, development of case report forms and statistical analysis plans
  • Experience in working with CROs
  • Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators and other site personnel involved in clinical trials.
  • Motivated to work in a fast-paced, high accountability, small company environment. A “can do” and collegial professional who leads through influence and interpersonal skills
  • Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail
  • Demonstrated ability to collaborate successfully with multiple functions in a team environment
  • Strong written and oral communication skills, including presentation skills
  • Ability to analyze and interpret clinical efficacy and safety data and develop written reports and presentations
  • Ability and desire to grow with the company, assume greater responsibility and build and lead a team

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