SERM Medical Director Specialty
Global Safety 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 (SERM) of all GSK products (marketed or developmental).
We are seeking talented and intellectually curious individuals who wish to join us in SERM and contribute to the advanced benefit-risk management of GSK’s Specialty portfolio of products, a large and diverse portfolio of products, encompassing Therapeutic Areas such as respiratory, neurosciences, diabetes, Global Health, anti-infectives and metabolic therapies, including immunotherapies and many more.
We offer experiences involving the opportunity to learn and contribute across the product lifecycle of development/newly approved/established and generics medicines, involving small molecules/ biologics/drug-device combos.
Who You Are: Are you a safety/pharmacovigilance physician with in-depth and hands-on experience?
As the SERM Medical Director (SERM Physician) you will provide high level medical expertise in the safety evaluation and risk management of 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 ongoing 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.
This role requires an experienced physician with a track record in the evaluation of clinical safety data, and with proven matrix team leadership and strong communication skills.
GSK considers the patient medical safety of its products to be of paramount importance.Key Responsibilities
Safety Governance and Risk Management activities
- Delivers the medical safety input into product development planning activities
- May lead or participate in discussion at Global Safety Board for safety related findings in clinical development
- Is the Global Safety representative (Safety Lead) on cross functional medical matrix teams and/or project teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues
- Establishes Safety Review Teams (SRTs) or co-ordinates leadership of multiple SRTs for projects and provides expert review of data and management of safety issues. Escalates safety issues identified through the Safety Review Process to Global Safety Board if necessary, via the SERM TA Head
- Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
- Ensures prompt notification to TA Head of reviewed protocols that are identified as potential PASS
- May review and provide technical approval for: investigator brochures, Development Core Safety Information (DCSI), protocols, Informed consents, final study reports and external data monitoring committee charters
- Provides medical expertise for risk evaluation and risk management planning
- Leads thinking in Global Safety around risk management plans and their implementation. For designated products, drives Pharmacovigilance and Risk Management Planning in the medical matrix and leads production and updating of Global Benefit-Risk Management Plans
- Leads safety input into regulatory benefit risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities
- Presents safety information at external meetings
Currently it is unlikely that post-marketing signal detection and evaluation activities will be required in this role although this could be required in the future.
Regulatory Reports and Submissions
- Leads the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
- If required, supports the Local Operating Companies by reviewing license renewal documentation (e.g. PSUR addenda line listings, clinical overviews, summary bridging reports) as required for each market
- Accountable for medical input, review and sign-off of periodic reports (e.g. PSURs) and renewal documentation submitted to regulatory agencies
Other SERM Activities
- Drives the review or production of the SERM component of Safety Data Exchange Agreements and escalates any deficiencies to the SERM Head to ensure quality and integrity of agreement. Advises on the preparation of licensing agreements in therapeutic area of responsibility
- Participates in due diligence activities by providing expert safety assessments and recommendations
- Participates in GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- May participate in a broader, cross-functional process team within GSK
- May participate in, or leads, cross-GSK activities such as safety advisory panels, task forces or scientific forums
- Raises concerns/ issues (i.e. sentinel events) to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated
- Trains, coaches and mentors scientists in the medical/scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents
- May deputise for the SERM Head
- Reviews and approves safety reports to investigators in partnership with the Clinical Development physician
- May provide input to, or participate in, meetings of an independent data monitoring committee (IDMC) or GSK internal safety review committee (iSRC)
Experience and Qualifications
We are looking for professionals with these required skills to achieve our goals:
- Medical Degree (i.e. clinician/physician/medical practitioner) from an accredited reputable University, with GMC registration or equivalent. For all, postgraduate medical specialisation is preferred or other relevant scientific/medical post-graduate qualification(s)
- Industry experience – especially multi-function experience e.g. clinical safety + medical affairs/clinical development
- Management/Leadership experience - either via direct line or matrix management of a team for safety lead role
- 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 Global Safety 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 and post-approval product maintenance in major countries
- Outstanding medical writing skills
- Sound computing skills
If you have the following characteristics, it would be a plus:
- Experience in Global Health, infectious diseases, anti-infectives and/or paediatrics
- Prior experience contributing to NDAs, BLAs, sNDA, and/or MAAs
- Prior experience of working in biologics/mono-clonal antibodies/immunotherapies
- Demonstrated track record of quality decision making and problem resolution based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context
- Excellent leadership skills in the matrix team setting. Proven ability to train, coach and mentor
- Ability to manage and co-ordinate tasks, projects and processes across a large organisation
- 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
- Highly developed negotiating and influencing skills. Ability to influence others to make sound decisions from a medical point of view by providing clear medical information
- Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality
- Contributes innovative ideas to address new issues or improve approaches to existing operations
- Ability to adjust behaviours and priorities based on changing environment
- Demonstrated ability to think tactically and strategically and take account of internal/external environment when considering safety issues and business processes
- Ability to engage in, and contribute to, broad GSK environment with confidence, impact, integrity and professionalism
- Leadership capability – demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities
- Strategic Thinking – maintains competitive advantage by carefully considering the issues and competing priorities within a situation, program or portfolio and then developing a strategy that includes the strategic application of available principles, tools and systems
- Business Acumen – Understands the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D
- Project Management – Demonstrates the discipline of risk-based planning, organising and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics.
Uniting science, technology, and talent to get ahead of disease together
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our R&D focus is to deliver a new generation of vaccines and medicines using the science of the immune system, human genetics and advanced technologies to get ahead of infectious diseases, HIV, cancer and other immune-mediated and respiratory diseases. We do all this with a commitment to operate responsibly for all our stakeholders by prioritising Innovation, Performance and Trust.
Our bold ambitions for patients are reflected in new commitments to growth and a significant step-change in delivery over the next five years. This means more GSK vaccines and medicines, including innovative new products, will reach more people who need them than ever before.
We have long believed that building trust is key to stronger performance, helping to create value for shareholders, impact for patients and society and a reason outstanding people choose to work for and with us. That’s why being a responsible business is an integral part of our strategy. Taking action on environmental, social and governance issues is a key driver in our strategy.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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 neurodiversity, 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).
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