Sr. Director of Pharmacovigilance

Job ID
2018-1125
Category
Clinical Development
Job Location
US-MA-Cambridge

Company Summary

Jounce Therapeutics, Inc. (JNCE) is a clinical stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long‑lasting benefits to patients. Through the use of its Translational Science Platform, Jounce first focuses on specific cell types within tumors to prioritize targets, and then identifies related biomarkers designed to match the right therapy to the right patient. Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS and is currently in a Phase 1/2 trial. For more information, please visit http://jouncetx.com/.

Role / Responsibilities

The Head of Pharmacovigilance will oversee all global pharmacovigilance activities for all Jounce clinical programs, including activities performed at Clinical Research Organizations and in collaboration with partners on Jounce clinical trials to ensure compliance with regulatory requirements, internal procedures and policies, GCP, and to ensure readiness for regulatory inspections and audits.

 

Responsibilites: 

  • Build and lead a team of pharmacovigilance professionals who embrace the Jounce values of Patients, Teamwork, Great Science, Integrity, Empowerment, and Fun.
  • Develop and implement best in class pharmacovigilance practices and procedures commensurate with stage of development of Jounce clinical programs.
  • Chair Jounce Executive Safety Committee and Monthly Safety Signal Review Meeting, and Safety related meetings with partners.
  • Ensure PV representation on program teams and close collaboration with colleagues in other disciplines, particularly clinical development, clinical operations, translational, research, and CMC.
  • Perform and/or provide oversight for the medical review of safety events to ensure accuracy and completeness of safety information, and to ensure consistency of medical coding of safety data.
  • Ensure PV support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, statistical analysis plans, annual reports, clinical study reports, investigator brochures, and other documents.
  • Collaborate with pharmacovigilance and drug safety colleagues from partners to align on a harmonized approach to identifying, evaluating and communicating safety issues.
  • Work closely with Regulatory Affairs regarding assessment and submission of individual case safety reports (ICSRs), aggregate reports, IND and BLA annual report summary statements, and all other relevant regulatory communications.
  • Responsible for the safety strategy during drug development, including development and implementation of Risk Management Plans, and monitoring and analysis of cumulative safety information in the context of the benefit-risk profile.

Qualifications

Requirements: 

  • PharmD or MD, MD preferred.
  • At least 7 years of pharmacovigilance experience in Oncology, with experience in immune-oncology and biologics preferred.
  • At least 3 years in a pharmacovigilance leadership role, with demonstrated skill in leading teams and managing pharmacovigilance departments.
  • Experience in drug development from Phase 1 through NDA or BLA.
  • Outstanding communication and presentation skills.
  • Working knowledge of FDA, EU, ICH regulations and guidances, and familiarity with common safety databases.
  • Ability to effectively collaborate in a dynamic, fast-paced environment.

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