The Associate Director, Safety Science is responsible for managing and ensuring the safety profile of the study drug as well as well-being of patients using Biomea Fusion’s products. The Associate Director is also responsible for developing and implementing safety strategies, and processes to identify, evaluate, and mitigate risks associated with our products. This role is onsite at our Redwood City, CA location, 3 days per week (Monday/Tuesday and Thursday).

Essential Responsibilities:

• Require safety scientist core competencies (signal detection and management strategy and execution, development/review of aggregate safety information and any risk mitigations activities) with a particular focus on clinical trial pharmacovigilance activities.
• Provide safety expertise for assigned developmental products in collaboration with Product Safety Physicians.
• Lead signal evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and interactions.
• Review or write safety sections and provide safety expertise for development of Protocols, IBs, ICFs, SAPs/ TFLs, Aggregate Safety Reports, Risk Management Plans, Medical Monitoring Plans, and CSRs.
• Collaborate with Data Analytics, Biostats and Data Management to ensure that outputs of safety data from both safety and clinical trial databases are standardized and of high quality to meet the need for preparation of aggregate safety reports (e.g., DSUR, PBRER) and other required aggregate safety analyses required by regulatory authorities.
• Assist in authoring and maintenance of the Safety Surveillance Plans.
• Provide analysis and insight for integrated Benefit/Risk assessments.
• Actively contribute to product safety surveillance, coordinating aspects of signal evaluation/safety review activities (e.g., scheduled review of scientific literature, SAE listings, data mining and data outputs from the safety database and the clinical database) to identify potential risks or emergent safety issues.
• Assist in leading and improving the oversight and monitoring of effectiveness of the risk minimization measures.
• Maintain and enhance knowledge of safety profiles for allocated products, including both Biomea and competitor products.
• Lead the evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates for regulatory inspections.
• Maintain accountability in completion of any assigned duties or tasks as instructed within assigned timelines or provide reasonable alternative plan when/if necessary.
• Maintain or improve quality in all activities, whether in direct involvement or upon awareness.
• Demonstrate problem solving ability by identification, gathering, and analyzing available information and requesting relevant additional information, using background experience and education.

Education and Experience Requirements:

• PharmD, RN, MD or PhD in a medical field or biological science and 8+ years industry experience in pharmacovigilance in an analytical role
• Prior experience as a safety scientist, a plus.
• Pharmaceutical product development experience required.
• Proven ability to work as a collaborative member of the management team.
• Intermediate knowledge working with a safety database for retrieval of safety information; Advanced knowledge of MedDRA.
• Familiarity with data mining tools and exploratory analyses tools such as Tableau Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus.
• Collaborative, team-oriented mindset with strong verbal and written communication skills.
• Self-motivated, detail-oriented with exceptional organizational and interpersonal skills.

Employment Type:

• Full-time

Equal Employment Opportunity:
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Compensation:
The expected salary range for this role is $165,000 to $195,000. An individual’s position within the range is influenced by multiple factors, including education, skills and years of relevant industry experience, and market dynamics. Base salary is one part of the overall total rewards program, which includes competitive cash compensation, including discretionary bonus program, equity awards and comprehensive benefits program.