Global Safety Program Lead, Senior Director
The Global Safety Program Lead, Senior Director is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s). The professional works with safety physicians and scientists responsible for developing, implementing, and applying safety strategy at asset and study level. Acting strategically, they generate opportunities and value for the asset or indication to optimize benefit‑risk and maintain a competitive advantage. The role includes line managing a team of safety physicians and/or scientists and, at times, deputizing for the Global Safety Head.
This Is What You Will Do
Operate according to the highest ethical, quality and compliance standards in accordance with global and local regulations, GxP practice, and company procedures.
You Will Be Responsible For
- Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indication(s).
- Accountable for the implementation and high‑quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s).
- Responsible for overall safety content for the product or indication(s) aligned to GPT strategy; sets safety team goals aligned to therapeutic area and product strategy.
- Accountable for safety TPP, safety go/no‑go criteria, safety communication/messaging and guidelines for toxicity management of the asset.
- Represent Global Patient Safety at governance and other forums where safety is involved, such as DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams (e.g., CPT and GPT) and advisory board meetings in partnership with the Global Safety Head.
- Accountable for the quality of key safety deliverables (e.g., Risk Management Plans and Periodic Safety Reports), compliance and adherence to PV regulations of the assigned asset(s).
- Lead response to complex technical issues for specific safety aspects of the assigned asset(s).
- Accountable for safety contribution to study designs and study concept delivery within the assigned program.
- Provide strategic safety knowledge and support to safety medical directors and scientists through initiation, execution and completion of clinical programs for the assigned asset(s).
- Lead the safety physicians and scientists to support the safety strategy and input into program design, monitoring and data interpretation from pre‑clinical and clinical studies, communication and post‑marketing surveillance, epidemiology and literature.
- Ensure compliance with Safety, Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
- Represent the company and be accountable for the quality of safety delivery, including regulatory submissions and responses to Health Authority queries, ethics committees, marketing approvals, investigator/site coordination, and safety issue resolution.
- May be required to support in‑licensing opportunities.
- Promote and enable cross‑functional, proactive and solution‑oriented team actions and behaviours.
- Accountable for implementation of new processes, systems and learning, including new ways of working.
- Prioritize risk mitigation strategies and effective troubleshooting.
Scientific Clinical Safety Analytical Accountabilities
- Maintain up‑to‑date knowledge of relevant safety scientific literature and communicate key impactful information.
- Accountable for proper data collection and interpretation to determine risks and inform labelling in global markets.
- Deliver balanced and statistically robust analyses of clinical safety data to drive interpretations and develop novel proposals.
- Serve as a source of scientific and clinical safety knowledge for the product team, especially in analysis and interpretation of scientific and clinical safety data.
You Will Need To Have
- Medical degree or equivalent degree in biomedicine or science.
- 5 years extensive relevant clinical, safety and risk‑management experience in the pharmaceutical, biotech, CRO industry, academia or health authorities.
- Proven track record of successful clinical safety delivery with demonstrated examples of strategic influence on clinical studies/programs.
- Ability to collaborate across a matrixed environment and influence cross‑functional leaders on decision‑making (e.g., Clinical Development, Medical Affairs, Regulatory Affairs).
- Thorough knowledge and understanding of pharmacovigilance & safety deliverables, standards and processes at a global level; including pre‑ and post‑launch experience.
- Experience of global regulatory submissions and interaction with major regulatory agencies.
- Demonstrated ability to successfully lead, coach and mentor other safety medical directors/scientists.
- Availability to travel domestically and internationally.
- Demonstrated ability to present complex topics to senior leaders at safety and development governing bodies for alignment and endorsement.
We Would Prefer For You To Have
- PhD (or other complementary degree) in a scientific discipline.
- Excellent, independent judgment based on leading‑edge knowledge and expertise.
- Excellent speaking skills and industry conference speaking experience.
- Demonstrated clinical safety and research expertise in an appropriate disease area.
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please indicate so in your application.
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