Director, Safety Scientist

AstraZeneca • Boston, MA

8d • $187,000 - $281,000 • Onsite

About The Position

The Director, Safety Scientist serves as a key leader within Global Patient Safety, providing strategic oversight and scientific leadership for the evaluation and management of safety risks across the portfolio. This role involves leading the scientific evaluation and management of safety risks, driving proactive safety strategies, ensuring robust benefit-risk assessments, and overseeing the delivery of safety science activities. The Director will shape safety strategy, lead and develop a team of Safety Scientists, promote scientific consistency, and collaborate effectively across clinical, regulatory, and other functions to strengthen the organization's overall safety capability.

Requirements

• Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD
• At least 7+ years’ experience in drug safety/pharmacovigilance within the pharmaceutical industry or biotech
• Subject matter expertise in global pharmacovigilance regulations, maintaining a strong, up-to-date working knowledge of evolving global requirements
• Experience with preparing aggregate safety reports and conducting signal surveillance
• Experience with clinical development including risk/benefit analysis and safety assessment
• Experience with risk management and minimization programs
• Proven skill set for strategic leadership in a cross functional matrix
• Strong analytical, problem solving, and scientific writing skills
• Demonstrated learning agility and ability to work independently
• Sound, independent judgement based on knowledge and expertise
• Advanced project leadership with strong organizational and prioritization skills
• Strong personal time-management and project-management skills
• Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis
• Understanding of downstream regulatory, patient, business, and reputational impact of PV actions

Nice To Haves

• Expertise with clinical and safety databases
• Experience in MedDRA coding and search strategies
• Experience with data visualization tools (e.g., Power BI, Spotfire)
• Experience with various roles in drug safety (e.g., case processing, operations)
• Mastery of Microsoft Word, PowerPoint and Excel

Responsibilities

• Lead and develop a team of safety scientists, drive performance, growth and scientific excellence
• Ensure appropriate resourcing and talent quality across assigned portfolio, including recruitment and team planning
• Lead initiatives for process improvement and cross-departmental process consistency
• Lead implementation of new processes, systems, and ways of working to enhance efficiency and scalability
• Provide oversight of vendors, including management, onboarding and training
• Represent GPS in clinical study teams and cross functional meetings
• Promote and enable cross-functional, proactive and solutions-orientated team actions and behaviors
• Lead workstreams and/or projects with high impact to the business
• Participate as a core member of GPS leadership team
• Set safety team goals aligned to TA and product strategy
• Collaborate with medical directors to lead project-specific safety strategy for assets within the assigned portfolio
• Responsible for the overall scientific and clinical safety content for the assigned portfolio
• Responsible for the implementation and the high-quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned portfolio
• Provides strategic safety knowledge and support to the safety scientists through initiation, execution, and completion of the clinical programs for the assigned portfolio
• Responsible for the quality of key safety deliverables (e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs))
• Responsible for ensuring compliance and adherence to PV regulations for the assigned portfolio
• Authoring or reviewing safety sections of clinical documents including but not limited to the clinical study protocol, informed consent form, Investigator’s Brochure, statistical analysis plan, clinical study report, and data monitoring committee documents
• Coordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globally
• Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis results
• Leading the authoring and project management of health authority queries
• Maintaining accountability for the authoring, review and finalization (i.e., endorsement, sign-off) of risk management plans and contributing to REMS documents
• Assisting GPS Medical Directors in the development of risk management strategy
• Supporting activities related to new drug applications and other regulatory filings including authoring, reviewing and providing input to eCTD modules (2.5 and 2.7.4), core product information (i.e., CCDS), and local labels
• Representing global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA)
• Maintains a high degree of understanding and awareness of new and emerging clinical safety developments globally
• Maintains strong networks globally; works with international colleagues and with external alliance partners on safety initiatives and regulatory issues

Benefits

• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health coverage
• Dental coverage
• Vision coverage
• Eligibility for various incentives
• Opportunity to receive short-term incentive bonuses
• Equity-based awards for salaried roles

What This Job Offers

• Job Type: Full-time
• Career Level: Director