Director of Safety & Pharmacovigilance
Director of Safety & Pharmacovigilance
Aspyrian Therapeutics Inc. is a privately funded, clinical-stage Biotech company. Our novel proprietary photoimmunotherapy technology uses antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product will initiate Phase 3 clinical testing this summer 2018 to treat recurrent HNSCC.
Patient safety is the highest priority at Aspyrian Therapeutics. We are looking for an experienced leader to head our Safety and Pharmacovigilance team. Reporting to the CMO, the Head of Drug Safety and Pharmacovigilance (PV) will be responsible for the strategic global implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the Company’s development and commercial activities, industry standards, and compliance with global regulations. He or she will lead and provide medical oversight for the pharmacovigilance, drug safety and risk management functions for investigational and marketed products, ensuring proactive and timely risk-benefit assessments of safety data.
Key Duties and Responsibilities
- Manage safety and pharmacovigilance of Aspyrian’s clinical studies.
- Build and lead a team of safety and pharmacovigilance professionals to coordinate global safety support as the company expands.
- Develop and implement best in class safety and pharmacovigilance practices and procedures commensurate with stage of development of Aspyrian’s clinical programs.
- Chair Aspyrian Safety Committee and Safety Signal Review Meetings, as well as other safety-related meetings with partners.
- Ensure safety and pharmacovigilance representation on program teams and close collaboration with colleagues in other disciplines, particularly clinical development, clinical operations, translational research, and CMC.
- Perform medical review of safety events to ensure accuracy and completeness of safety information, ensure consistent medical coding of safety data, and compliant submissions with laws and regulations.
- Ensure pharmacovigilance 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 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 and pharmacovigilance 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.
Desired Education, Skills and Experience
- MD/DO with 2+ years of residency with patient management experience
- At least 8 years of safety/pharmacovigilance experience in the pharmaceutical industry with experience in oncology.
- At least 3 years in a safety/pharmacovigilance leadership role (Associate Director or above), with demonstrated skill in leading teams and managing safety and pharmacovigilance departments.
- Experience in drug development from Phase 1 through NDA or BLA.
- Outstanding communication and presentation skills.
- Working knowledge of FDA, EU, PMDA, ICH regulations and guidance, and familiarity with common safety databases.
- Ability to effectively collaborate in a dynamic, fast-paced environment, and make independent decisions.
- Effectively analyze clinical data and present recommendations/opinions in group environment both internally and externally.
- Write, review and provide input on technical documents
- Fluency, both written and oral, in English
We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more. We are proud to be an EOE.