What are the responsibilities and job description for the Executive Director, Head of Pharmacovigilance position at TScan Therapeutics?
Position Summary:
TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an Executive Director, Head of Pharmacovigilance to support the execution of our oncology studies in solid tumors and in hematological cancers. The ideal candidate should have relevant experience in oncology, ideally with a cell therapy product, and enjoy a fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
Responsibilities:
- Provide medical safety expertise and act as the medical safety lead for TScan clinical studies
- Review safety reports from the PV vendor, including conducting initial triage and causality assessments, generating and resolving queries, and following up with the PV vendor and sites as needed
- Chair internal safety meetings such as the Safety Management Team meeting
- Participate in study safety meetings such as DSMBs, Dose Escalation meetings, PI calls, etc
- Review and approve safety sections of clinical documents (e.g. protocol, ICFs, IBs, Reference Safety Information, etc)
- Lead and contribute to signal detection and analyses of similar events activities to identify potential risks
- Lead the development, implementation and execution of a Risk Management Plan
- Work with the internal team to respond to inquiries from regulatory agencies
- Work with QA and consultants to develop necessary PV SOPs
- Manage direct report(s)
Requirements:
- MD (or equivalent) or PharmD required
- 8 - 10 years of experience managing PV activities in oncology clinical studies, preferably with experience in cell therapy studies
- Excellent oral and written business communication skills and ability to work in a flexible, matrix environment
- Knowledge of drug discovery and development program management from Phase 1 registrational studies
- Advanced working knowledge of all relevant guidelines, including ICH, GCP, and relevant PV regulations
- Experience using PV databases (e.g Argus and Veeva) and medical coding systems such as MedDRA
- Experience managing direct reports
- Ability to drive a team-oriented environment, motivate and influence others, lead strategic discussions and interact with critical internal and external stakeholders
About TScan:
TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScans platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Womens Hospital and Harvard Medical School. TScans transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases.
Do YOU have the anatomy of a TScanner?
Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are passionate, fun, flexible, and team oriented. Sound like you? Apply today.
EEO Statement
TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position for which the applicant has applied, please contact the recruiter.
Recruitment & Staffing Agencies
TScan Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics, and TScan Therapeutics will not owe any referral or other fees with respect thereto.
