SERM Senior Medical Director, Oncology (Waltham)

Business IntroductionAt 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&DPosition SummaryAs SERM Senior Medical Director, Oncology, you will lead clinical safety and pharmacovigilance strategy for oncology assets within Global Safety.You will oversee rigorous review, interpretation and communication of safety data, ensuring timely identification, escalation and management of safety issues.Working in a global, cross-functional matrix, you will collaborate with senior governance and partner teams to drive evidence-based safety decisions. You will also mentor SERM colleagues, strengthening safety and risk-management capabilities and supporting their development across the portfolio.ResponsibilitiesProvide expert leadership in clinical safety and pharmacovigilance for oncology assets, including signal evaluation, benefit–risk assessment, regulatory submissions and proactive risk-management strategies.Oversee the review, interpretation and communication of safety data; identify, escalate and manage safety issues through established safety governance forums.Develop and implement safety strategies, policies and processes aligned with Global Safety operational and strategic plans.Coach and mentor medical and scientific colleagues in SERM in signal evaluation, risk management, and preparation of regulatory safety deliverables.Lead within a global, cross-functional matrix, building strong collaborative relationships and influencing internal and external stakeholders on safety topics.Lead or oversee SERM safety input into due diligence and other key strategic activities, ensuring safety perspectives shape decision-making.Why You?Basic QualificationWe are seeking professionals with the following required skills and qualifications to help us achieve our goals:Medical degree, with completion of a formal postgraduate clinical training, residency or specialty trainingExperience in the pharmaceutical or biotechnology industry working in pharmacovigilance or drug safety.Experience in clinical safety and pharmacovigilance activities, including evidence generation, benefit–risk assessment, causality assessment and evaluation of safety signals.Experience developing and executing safety strategies for products in clinical development.Experience with international pharmacovigilance requirements and drug development and approval processes (for example ICH, GVP modules, CIOMS initiatives).Experience of leading large matrix organizations and cross-functional teams.Preferred QualificationExperience developing and executing safety strategies for products in clinical development, preferably in OncologyProven record of high-quality, timely decision-making and creative problem-solving in complex or critical safety situations.Experience leading or contributing to safety governance activities, such as safety advisory panels and senior governance committees.Experience with successful global regulatory filings (e.g., IND/CTA, NDA/BLA, and EMA/MHRA MAAs).Recognised expertise in pharmacovigilance regulations and methodologies, and experience contributing to external pharmacovigilance or industry initiatives.Excellent verbal and written communication skills, with the ability to influence senior internal and external stakeholders and drive change to implementation.Resilience and adaptability, with the ability to adjust priorities in a changing environment while maintaining focus on patient safety and risk reduction.Working ModelThis role is hybrid. You will be expected to work on site at a US office a minimum of two days per week, with flexibility for remote work for the remainder.How we work and what we valueWe put patients first and act with transparency and integrity. We value clear communication, teamwork, and practical problem solving. We welcome applicants from all backgrounds and support inclusion. We look for people who want to make a meaningful impact on patient health.Ready to make a difference?If this role speaks to you, please apply now. We look forward to learning how your experience and perspective can help us get ahead of disease together.SkillsClinical Development, Drug Regulatory Affairs, Evidence Based Decision Making, Good Clinical Practice (GCP), Influencing Without Authority, Learning Agility, People Management, Project Management, Scientific Presentations, Strategic Thinking• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $284,625 to $474,375. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. 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.If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - View email address on apply.placed-app.com 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.Important notice to Employment businesses/ AgenciesGSK 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 SummaryLocation: USA - Pennsylvania - Upper Providence; USA - Massachusetts - WalthamType: Full time