Global Safety Program Lead

AstraZeneca • Gaithersburg, MD

3d • $288,059 - $432,089

About The Position

The Global Safety Program Lead is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of assigned assets or indications. The role works with safety physicians and scientists to develop, implement, and apply safety strategy at asset and study levels, while generating strategic opportunities and value to optimize benefit-risk and maintain competitive advantage. The position line manages safety physicians and/or scientists and may deputize for the Global Safety Head. The role operates to high ethical, quality, and compliance standards in accordance with global and local regulations, GxP practices, and company procedures.

The role is accountable for scientific and clinical safety content, safety team goals, safety strategy and deliverables, and representation of Global Patient Safety at governance and other forums. It leads safety input to program design, study design, monitoring, data interpretation, communications, and post-marketing surveillance. Responsibilities also include risk analysis and mitigation, regulatory and safety submissions, responses to health authority queries, and resolving safety issues with study teams. The lead supports cross-functional collaboration, process implementation, and the development and performance of the safety team.

The position requires a medical degree or equivalent degree in biomedicine or science and at least five years of relevant clinical, safety, and risk-management experience. Candidates should have a record of successful clinical safety delivery and strategic influence, global pharmacovigilance knowledge, experience with regulatory submissions and major regulatory agencies, and demonstrated ability to lead and mentor safety professionals. Domestic and international travel is required.

The annual base pay range is $288,059.20–$432,088.80 USD. The position offers a short-term incentive bonus opportunity and, for salaried roles, potential participation in an equity-based long-term incentive program. Benefits include a qualified retirement program (401(k)), paid vacation and holidays, paid leaves, and medical, prescription drug, dental, and vision coverage.

Requirements

• Medical degree or equivalent degree in biomedicine or science.
• At least 5 years of extensive relevant clinical, safety, and risk-management experience in the pharmaceutical, biotech, CRO, academic, or health-authority sectors.
• Proven record of successful clinical safety delivery, with examples of strategic influence on clinical studies or programs.
• Ability to collaborate in a matrixed environment and influence cross-functional leaders in decision-making.
• Thorough global knowledge and understanding of pharmacovigilance and safety deliverables, standards, and processes, including pre- and post-launch experience.
• Experience with global regulatory submissions and interactions with major regulatory agencies.
• Demonstrated ability to lead, coach, and mentor safety medical directors or scientists.
• Availability to travel domestically and internationally.
• Ability to present complex topics to senior leaders at safety and development governance forums for alignment and endorsement.

Nice To Haves

• PhD or another complementary degree in a scientific discipline.
• Excellent independent judgment based on leading-edge knowledge and expertise.
• Excellent speaking skills and experience speaking at industry conferences.
• Demonstrated clinical safety and research expertise in an appropriate disease area.

Responsibilities

• Account for safety strategy, delivery, and oversight for assigned assets or indications.
• Own scientific and clinical safety content and ensure high-quality delivery by the Safety & Strategy Management Team and Safety Surveillance Team.
• Set safety team goals aligned with therapeutic-area and product strategies; oversee safety target product profiles, safety Go/No-Go criteria, safety communications, and toxicity-management guidelines.
• Represent Global Patient Safety at governance forums, product teams, advisory boards, and other meetings where safety is involved, in partnership with the Global Safety Head.
• Ensure quality of safety deliverables, including Risk Management Plans and Periodic Safety Reports, and compliance with pharmacovigilance regulations.
• Lead responses to complex technical safety issues for assigned assets.
• Provide safety contributions to study designs and study concepts, and guide safety input into program design, monitoring, and interpretation of preclinical and clinical data.
• Lead safety physicians and scientists supporting safety strategy, communications, post-marketing surveillance, epidemiology, preclinical work, and literature review.
• Ensure the team's work complies with Safety, Health and Environment standards and other applicable internal and external requirements.
• Represent the company and oversee safety delivery for regulatory submissions and responses to health authorities, ethics committees, marketing companies, investigators, and sites; clarify and resolve study-team safety issues.
• Promote cross-functional, proactive, solutions-oriented collaboration and implement new processes, systems, learning, and ways of working.
• Prioritize risk-mitigation strategies and effective troubleshooting.
• Line manage, lead, coach, and mentor safety physicians and/or scientists.
• Maintain current knowledge of relevant safety literature and emerging global clinical safety developments, and communicate impactful information.
• Ensure appropriate safety data collection and interpretation to determine risks and inform product labeling in global markets.
• Deliver balanced, statistically robust clinical safety analyses that inform interpretation and novel proposals.
• Serve as a source of scientific and clinical safety expertise for product teams.
• Maintain global networks and work with international colleagues and external alliance partners on safety initiatives and regulatory issues.
• Provide safety guidance for investigator-initiated trials in cooperation with regional marketing companies when required.
• Support in-licensing opportunities when required.
• Travel domestically and internationally.

Benefits

• Short-term incentive bonus opportunity.
• Eligibility to participate in an equity-based long-term incentive program for salaried roles.
• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical coverage.
• Prescription drug coverage.
• Dental coverage.
• Vision coverage.

What This Job Offers

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