Who We Are: The Oncology, Immunology, and Early Phase Safety Evaluation and Risk Management (SERM) Group
Global Clinical Safety & Pharmacovigilance (GCSP) is responsible for the collection, processing and regulatory reporting of adverse events experienced by patients receiving GSK products and for the ongoing safety evaluation and risk management of all GSK products (marketed or developmental).
We are seeking talented and intellectually curious individuals who wish to join us and contribute to the development and support of novel therapies in the therapeutic areas of Oncology and Immunology. There are also opportunities to work exclusively with treatments that are in the early phases of development. GSK is not developing a pipeline of “me too” drugs, rather they are seeking to be leaders in Oncology in the areas of immuno-oncology, synthetic lethality, epigenetics, and cellular & gene therapy. Additionally, GSK is leveraging its expertise in Immunology to bring forward therapies to treat COVID-19. Our portfolio ranges from first-in-human compounds to marketed drugs, so there is the opportunity to learn and contribute across life cycle management. These are exciting positions because of the patients who motivate and the science which amazes us!
As the SERM Medical Director, you will provide high level medical expertise in the safety evaluation and risk management of new and cutting-edge medicines in clinical development and/or the post-marketing setting. You will ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives.
You will have a proven ability to lead safety evaluation activities, ensuring that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes. You will influence at all levels of the organisation using your experience, confidence and credibility, and represent the disease area or product area safety strategy at key internal GSK meetings and externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners. Additionally, you will be accountable for medical review and sign-off for regulatory documents, including periodic safety update reports (PSURs).
This role requires an experienced safety physician with proven matrix team leadership and strong communication skills.
GSK considers the clinical safety of its products to be of paramount importance.Key ResponsibilitiesPosition Summary
Are you a safety/pharmacovigilance physician with in-depth and hands-on experience?Why you?Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Medical Degree, specialisation preferred (Board Certified or Eligible) with minimum 2 years clinical practice experience
- Experience in a pharma/biotech or regulatory agency required in a relevant function such as clinical safety or pharmacovigilance
- 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. Likely to be recognised as an authority in this area at high levels within GSK outside of Clinical Safety and Pharmacovigilance and possibly in the external international pharmacovigilance arena
- Expert evaluation skills and analytical thinking
- In depth knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilisation and safety at the population level
- In depth knowledge of medical and drug terminology and a sound foundation in pharmacology.
- Good medical judgement and ability to make medical decisions
- In depth knowledge of clinical development process
- In depth understanding of drug approval process in major countries
- Outstanding medical writing skills
- Sound computing skills Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Prior experience in Oncology
- Prior experience contributing to NDAs, BLAs, sNDA, and/or MAAs
- Prior experience of working in biologics such as mono-clonal antibodies would be advantageous Why GSK?
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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