Global Safety Program Lead – Infectious Disease Therapeutic Area

We are looking for an experienced Safety Program Lead to drive the safety strategy, delivery, and oversight for assigned assets, working closely with safety physicians, scientists, and global regulatory teams.

Overview

The role reports to the Global Safety Head and involves strategic leadership of safety initiatives, guidance on benefit–risk assessment, and direct responsibility for safety deliverables including Risk Management Plans and Periodic Safety Reports. The holder will line‑manage a team of safety physicians and scientists, represent the company at governance forums, and collaborate across the organization to embed safety considerations into product development.

Responsibilities

• Accountable for overall scientific and clinical safety content for assigned assets or indications.


• Lead the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned assets.


• Create and maintain safety TPP, Go/No Go criteria, communication/messaging, and toxicity management guidelines for each asset.


• Represent the organization in governance and other forums such as DRC, eCRC, SARB, FSIRB, DSMB/DMC, and MARC, ensuring alignment with global safety and product strategy.


• Ensure quality and regulatory compliance of key safety deliverables (RMPs, PSRs) and adherence to PV regulations.


• Lead responses to complex technical safety issues, study design input, and data interpretation across pre‑clinical and clinical phases.






• Collaborate with regulatory affairs and medical affairs to support study reports, regulatory submissions, and responses to health authority queries.


• Support in‑licensing opportunities and cross‑functional safety initiatives.


• Implement new processes and systems to enhance safety operations and promote a proactive, solutions‑oriented culture.


• Prioritize risk mitigation strategies and troubleshoot operational challenges.


• Line‑manage a team of safety physicians and scientists.

Scientific & Clinical Safety Analytical Accountability

• Maintain up‑to‑date knowledge of safety scientific literature and communicate key findings.


• Ensure proper data collection and interpretation to inform global labeling and risk assessments.


• Deliver statistically robust analyses of clinical safety data to support decision‑making.


• Serve as a source of safety expertise for product teams.

Messaging and External Impact

• Monitor emerging safety developments globally and maintain robust network relationships.






• Collaborate with international colleagues and external partners on safety initiatives and regulatory issues.


• Provide safety guidance for investigator‑initiated trials in partnership with regional marketing teams, if required.

Qualifications

• Medical degree or equivalent degree in biomedicine or science.


• Minimum 5 years of relevant clinical, safety, and risk‑management experience in pharma, biotech, CRO, academia, or health authorities.


• Proven track record of successful clinical safety delivery and strategic influence on programs.


• Strong collaboration skills in a matrixed environment with leaders in Clinical Development, Medical Affairs, and Regulatory Affairs.


• Thorough knowledge of pharmacovigilance, safety deliverables, and global regulatory processes (pre‑ and post‑launch).


• Experience with global regulatory submissions and interactions with major regulatory agencies.


• Leadership experience in coaching, mentoring, and managing safety professionals.


• Willingness to travel domestically and internationally.


• Excellent presentation skills for conveying complex safety topics to senior leaders.

Desirable

• PhD or other complementary scientific degree.


• Excellent independent judgment and innovative thinking.


• Industry conference speaking experience with strong communication skills.


• Demonstrated clinical safety and research expertise in a relevant disease area.