Accountable for the quality of key safety deliverables e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance and adherence to PV regulations of the assigned asset(s).
Leads response to complex technical issues for specific safety aspects for the assigned asset(s).
Is accountable for safety contribution to study designs and study concept delivery within their assigned program
Through integrated understanding of the product strategy, provides strategic safety knowledge and support to the safety medical directors and scientists through initiation, execution, and completion of the clinical programs for the assigned asset(s).
Leads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset.
Ensures that own work and work of team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
Represents the Company and accountable for the quality of safety delivery e.g., regulatory submissions, answers to Health Authority Queries, Ethic Committees, Marketing Companies, investigators/sites, and provides clarifications as well as solves safety issues in the study team.
May be required to support in-licensing opportunities.
Promotes and enables cross-functional, proactive and solutions-orientated team actions and behaviours
Accountable for implementation of new processes, systems and learning, including new ways of working.
Prioritizes risk mitigation strategies and effective trouble shooting.
Line manages a team of safety physicians and / or scientists.
Scientific clinical safety analytical accountabilities
Maintains up-to-date knowledge of the relevant safety scientific literature, and is able to clearly communicate key impactful information,
Accountable for proper data collection and interpretation for determination of the risks and inform the label in markets globally
Delivers analyses of clinical safety data in a balanced and statistically robust manner, to drive interpretations and develop novel proposals.
Serves as a source of scientific and clinical safety knowledge for the Product Team, in the analyses and interpretation of scientific and clinical safety data.
Messaging and External Impact
Maintains a high degree of understanding and awareness of new and emerging clinical safety developments, globally.
Maintains strong networks globally and works with international colleagues and with external alliance partners on safety initiatives and regulatory issues.
If required, able to provide safety guidance for investigator-initiated trials in cooperation with regional marketing companies.
This Job description is not exhaustive and may include other other job-related duties as assigned.
Essential for the role
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 to 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 interacting with major regulatory agencies.
Demonstrated ability to successfully lead, coach, and mentor other safety medical directors/scientists.
Available to travel domestically and internationally
Demonstrated ability to present complex topics to senior leaders at safety and development governances for alignment and endorsement.
Desirable for the role
PhD (or other complementary degree) in scientific discipline.
Excellent, independent judgment based on leading-edge knowledge and expertise.
Excellent speaking skills, industry conference speaking experience.
Excellent, independent judgment based on knowledge and expertise.
Demonstrated clinical safety and research expertise in an appropriate disease area.
The annual base pay (or hourly rate of compensation) for this position ranges from $288,059.20 - $432,088.80USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Closing Date 30-Dec-2026 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 complete the corresponding section in the application form.
