SERM Senior Scientific Director, Oncology
Job Location:
Waltham, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Business Introduction
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 peoples 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. Were uniting science technology and talent to get ahead of disease together.
Find out more:
Our approach to R&D
Position Summary
Key Responsibilities
- Define and drive the clinical safety and pharmacovigilance strategy for assigned oncology assets in alignment with global business objectives
- Lead safety governance activities ensuring appropriate escalation communication and resolution of emerging safety issues
- Anticipate identify and address safety signals ensuring effective and timely implementation of risk mitigation strategies
- Provide strategic recommendations on benefit-risk profiles to support development and lifecycle management decisions
- Exercise expert scientific judgment in the evaluation and interpretation of complex safety data
- Lead safety data analyses and signal detection activities ensuring scientifically robust conclusions and documentation
- Guide causality assessments benefit-risk evaluations and safety evidence generation across the portfolio
- Serve as a recognized subject matter expert in pharmacovigilance methodologies and regulatory expectations
- Oversee proactive identification and assessment of safety signals from clinical trials post-marketing data and real-world evidence
- Develop and implement risk management strategies including labeling updates risk minimization measures and stakeholder communication plans
- Partner closely with safety physicians and cross-functional teams to ensure comprehensive safety oversight
- Lead and influence global matrixed teams to ensure alignment and execution of safety strategies
- Build strong collaborative relationships across clinical regulatory medical and commercial functions
- Contribute to due diligence activities including safety assessments for business development opportunities
- Demonstrate agility and resilience in a dynamic fast-paced environment
- Provide strategic oversight and input into regulatory safety documents and responses to Health Authorities
- Ensure compliance with global pharmacovigilance regulations (e.g. ICH GVP CIOMS)
- Represent safety function in governance forums and external engagements as needed
- Drive clear concise and influential communication with internal and external stakeholders
Why You
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Advanced degree in a relevant scientific or healthcare discipline (e.g. PhD PharmD RN/BSN/MSN NP RPh or equivalent)
- Significant experience (7 years) in pharmacovigilance and drug safety within the pharmaceutical or biotech industry
- Deep expertise in clinical safety across drug development and post-marketing environments
- Demonstrated experience in:
- Signal detection and evaluation
- Benefit-risk assessment and safety decision-making
- Risk management strategy development
- Strong knowledge of global pharmacovigilance regulations (ICH GVP CIOMS)
- Experience working in complex global matrix organizations
- Proven ability to influence decisions and lead safety strategy at a program or portfolio level
Preferred Qualification
If you have the following characteristics it would be a plus:
- Prior leadership experience in a global SERM or safety function.
- Experience with regulatory interactions and inspections in the US and other regions.
- Familiarity with pharmacoepidemiology real-world evidence or biostatistics approaches.
- Experience preparing Development Core Safety Information PBRERs or DSURs.
- Oncology therapeutic area expertise
- Experience leading global safety teams or major programs
- Experience interacting directly with Health Authorities and regulatory submissions
- Track record of influencing senior leadership and governance bodies
- Demonstrated success in mentoring and developing scientific talent
Ready to apply
If this role aligns with your skills and ambition please submit your application. We look forward to learning how you can help us get ahead of disease together.
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 were 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 -
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.
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 GSKs 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 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 GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Director
About Company
About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
