SERM Physician, Early Phase/Cell and Gene Therapy Group

Job content

Site Name: UK - London - Brentford
Posted Date: Jun 8 2021

Are you looking for an exciting opportunity to make an impact as a physician safety lead across multiple early phase programmes, leading the safety strategy for assets across immuno-oncology, cell and gene therapy and other specialty therapy areas?

This is a fantastic opportunity to utilise your pharmacovigilance knowledge and experience, and to be the Safety Lead for a number of assets across early phase development (including oncology) and Cell and Gene therapies, within a world leading pharmaceutical company.

Key aspects to this role include leading the safety strategy for your assets and engaging across matrix teams to ensure appropriate risk mitigation and ongoing benefit :risk evaluation. 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.

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.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

Why you?

– Provides high level medical 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
– Accountable for medical review and sign-off for regulatory documents, including periodic development safety update reports (DSURs)
– Delivers the clinical safety input into clinical development planning activities
– Represents GCSP Global Safety 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.

–Key contributor to dose escalation decisions in early phase studies

– 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
– Establishes and chairs the Safety Review Team (SRT) for projects in development and provides expert review of data and management of safety issues. Escalates safety signals identified through the Safety Review Process to Global Safety Board if necessary, via the 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
– Proactively leads the assessment of safety data and discusses the results with the SERM TA Director/ product scientist
– Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations
– In consultation with the product scientist and Clinical Development representatives, prepares the Development Core Safety Information (DCSI) for assigned development products; co-ordinates and chairs meetings and tracks timelines to ensure completion
– Drives production of periodic regulatory documents (DSURs, Annual Reports) according to the agreed process and timelines
– Advises on strategy for the content of high profile DSURs
– Participates in due diligence activities by providing expert safety assessments and recommendations
– 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 provide input to, or participate in, meetings of an independent data monitoring committee (IDMC) or GSK internal safety review committee (iSRC)

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

– Medical degree (GMC registered, or equivalent GMC recognised qualification)

– 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 the therapeutic area of assigned GSK products

– Sound knowledge of other related disciplines, e.g. statistics, clinical pharmacology, epidemiology relevant to assessing drug utilisation and safety at the population level

– Clear understanding of clinical development process

– Previous experience as a physician lead for a safety product, preferably a product in clinical development

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Previous experience in oncology studies would be an advantage
  
  

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
• Managing individual performance.
• Creating a performance culture and driving results, prioritisation, execution, delivering performance.
• Setting strategic direction and leading on-going organisational transformation.
• Building a resilient organisation.
• Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
• Managing P&L and capital allocation.
  
  

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.

Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

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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