SERM Scientific Director

GSK, Holborn, Camden

SERM Scientific Director

£111750-£186250

GSK, Holborn, Camden

  • Full time
  • Permanent
  • Remote working

Posted today, 6 Jun | Get your application in now to be one of the first to apply.

Closing date: Closing date not specified

Job ref: 77f70f40dc844c4dab690b9d27429b42

Location ref: Holborn, Camden

Full Job Description

Provides advanced scientific expertise in the safety evaluation and risk management of key GSK oncology assets in clinical development. Leads the identification, assessment, and communication of safety risks to ensure robust benefit-risk profiles and protection of patients globally. This role plays a critical part in shaping the safety strategy of innovative oncology therapies, partnering cross-functionally to enable high-quality, timely decision-making and proactive risk mitigation across the portfolio.,

  • Lead pharmacovigilance activities and risk mitigation strategies for assigned oncology assets and clinical trials
  • Drive the evaluation and interpretation of safety data, including signal detection and assessment
  • Develop strategic approaches for safety issue evaluation within clinical development programmes
  • Contribute to safety components of global regulatory submissions (e.g., INDs, DSURs, IBs)
  • Perform literature review, clinical data synthesis, and integrated safety analyses to inform decision-making
  • Ensure high-quality, timely delivery while managing multiple priorities
  • Cross-Functional Matrix Leadership
  • Represent Safety Evaluation & Risk Management (SERM) on Clinical Matrix and Project Teams
  • Lead cross-functional efforts to address urgent and complex product safety issues
  • Partner closely with Safety Physicians and stakeholders to prepare for and contribute to Safety Review Team (SRT) meetings
  • Escalate emerging safety issues to senior leadership and governance bodies as appropriate
  • Build strong working relationships and lead effectively within a global matrix organisation
  • Coach and mentor colleagues as appropriate
  • Communication, Influence and Strategy
  • Present safety recommendations and emerging risks to senior governance committees
  • Represent GSK in interactions with regulatory authorities, external experts, and partners
  • Apply strategic thinking to evaluate internal and external factors influencing safety decisions
  • Contribute to the development of long-term safety and clinical programme strategies
  • Identify opportunities for continuous improvement and innovation in safety evaluation processes
  • Communicate complex scientific information clearly to a range of audiences, This is a hybrid role based in the United Kingdom with a mix of office and remote working. Some travel may be required for meetings and regulatory interactions.
  • What we value We seek people who work with integrity, focus on patients and collaborate respectfully. We welcome different perspectives and promote inclusion in our teams. We support development and learning so you can grow while making a meaningful impact on patient safety.

  • Degree in a health-related discipline (e.g., Life Sciences, Pharmacy, Medicine, Nursing), with significant relevant experience
  • Substantial experience in pharmacovigilance, drug safety, or a related function within the pharmaceutical or biotechnology industry
  • Experience supporting safety in oncology clinical development programmes
  • Strong expertise in:
  • + Signal detection and risk assessment + Clinical trial safety oversight + Regulatory safety documentation and submissions
  • Knowledge of global pharmacovigilance regulations (e.g., ICH, GVP, CIOMS)
  • Proven ability to work effectively in a complex, global matrix environment
  • Strong analytical, communication, and problem-solving skills
  • Preferred Qualification If you have the following characteristics, it would be a plus:
  • Advanced degree (e.g., PhD, PharmD, MD or equivalent)
  • Experience interacting with global regulatory authorities
  • Experience presenting to senior governance or safety review committees
  • Demonstrated leadership experience, including mentoring or team leadership in a matrix setting
  • Track record of influencing cross-functional teams and contributing to strategic decision-making
  • Experience supporting late-stage clinical development programmes

    At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
  • Find out more: Our approach to R&D, Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov

Direct job link

https://www.jobs24.co.uk/job/serm-scientific-director-126940691