Head of Medical Safety
About Aura :
At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery. By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.
Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.
Position Summary:
Reporting to the Chief Medical Officer, the Head of Medical Safety (Drug and Device) will be responsible for leading the safety/pharmacovigilance function, providing leadership and clinical support to drug/device safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing, ensuring safety aspects of all clinical trials and safety data analysis to support signal detection and risk/benefit profile evaluation.
This role is accountable for the risk/benefit activities including signal detection, risk management, risk mitigation plans, safety analyses in aggregate reports, oversight and management of safety vendor and medical review of ICSR as needed. The Head of Medical Safety will be responsible for the scientific review of safety related information in study protocols, study reports, Investigator Brochure, ICF, CCDS, CCSI, product labelling, DSUR/PSUR/PBRER as well as in responses to specific questions from Health Authorities, IRBs and ECs.
Job Responsibilities:
- With input from the CMO, lead all aspects of Medical Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
- Provide medical and drug/device safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, oversight/medical review of individual case reports of serious adverse events and compile analysis of similar events (AOSE)
- Address safety-related topics as a member of the Clinical Leadership Team
- Work with Medical Directors, Safety Vendor/CRO Safety Physicians, Clinical Operations and cross-functional team members on safety monitoring and assessment activities
- Set up and act as chair for safety data review meetings
- Set up and run DMCs/DSMBs
- Oversight of event coding and safety database reconciliation at the trial and program levels
- Strong safety vendor governance and oversight to ensure compliance with safety data management and reporting requirements in all relevant territories
- Develop and manage the Safety team, supporting the recruitment, training and professional development of Safety Department personnel
- Responsible for the scientific review of safety related information in study protocols, study reports, Investigator Brochure, ICF, CCDS, CCSI, product labelling, as well as in responses to specific questions from Health Authorities, IRBs and ECs.
- Lead the development and review of aggregate reports (eg, DSUR) and device related (development) Risk Management Plans (RMP) in collaboration with Head of Device Development
- Ensure effective SOPs are in place and ensure compliance with SOPs, national and international, regulatory, safety and pharmacovigilance regulations
- Oversee medical safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations
Qualifications and Experience:
- MD or foreign equivalent
- 5+ years’ experience in Drug Safety/ Pharmacovigilance in a pharma/biotech preferred, device safety experience is a big plus
- Good working knowledge of US, EU and other global drug/device safety regulations, CIOMS and ICH guidelines
- Demonstrated leadership abilities or oversight roles
- Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities
- Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
- Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)
- Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)
- Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/ BLA submissions
- Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS)/Company Core Safety Information (CCSI) and local labels
- Ability to build relationships, collaborate and influence across disciplines and external stakeholders
- Experience with MedDRA coding, WHO Drug, Points to Consider, AOSE, and SMQs
- Excellent verbal, written and presentation skills
Benefits and Perks :
- Health insurance with FULL premium coverage
- 401K with company match
- Employee Stock Purchase Program (ESPP)
- Competitive Paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
- Free parking at our Brighton, MA location