SERM Senior Director, Open to flexible working
We are seeking a highly motivated individual as a Senior Director (scientist), Early Phase and Cell and Gene therapy team, within our Global Safety Department. This is a fantastic opportunity to utilise your pharmacovigilance knowledge and experience, to work independently to be the Safety Lead for early phase assets, or to work as part of an Early Phase / Cell and Gene therapy team in further development of an asset beyond Phase 1.
Key aspects to this role include leading the safety strategy for your assets, working to ensure appropriate risk mitigation and ongoing benefit-risk evaluation for your own products. As Senior Director, you will be expected to drive discussions (and management) of safety issues, including presenting safety-related strategy or findings to senior stakeholders (such as Global Safety SVP/VP and Senior Leadership Teams) and to GSK's governance bodies.
Responsibilities include some of the following:
- Provides high level expertise in the safety evaluation and risk management of key GSK assets or other highly complex products in clinical development
- Has a proven ability to lead safety evaluation activities, ensures that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes and shows confidence, credibility and influence at all levels of the organisation
- Delivers the clinical safety input into clinical development planning activities
- Represents GCSP on cross functional Clinical Matrix Teams and/or Project Teams.
- Leads cross-functional ad hoc teams to address urgent and important product safety issues
- Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters.
- May lead or participate in discussion at Global Safety Board for safety related findings in clinical development.
- Presents safety information at clinical investigator and commercial meetings.
- Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
We are looking for professionals with these required skills to achieve our goals:
- Extensive knowledge of safety, preferably within GSK
- Extensive knowledge around processes required for early phase safety and experience in contributing to GSK workstreams to optimise safety related process
- Sound therapy area knowledge across oncology and non-oncology therapy areas
- Expert evaluation skills and analytical thinking
- Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
- Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education
- Sound knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level
- Clear understanding of clinical development process
- Experience in being the Safety Lead for a product
- Experience with Cell and Gene therapies
- Excellent leadership skills in the matrix team setting. Proven ability to train, coach and mentor
- Highly effective communication skills; able to present complex data to groups at all levels of the organisation and externally to GSK. Makes medical information/concepts accessible for non-physicians
- Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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