SERM Senior Scientific Director, Oncology

GSK; Upper Providence (Delaware County); Hybrid; USD 218,000 - 363,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Vacation

Parental leave

Job summary

GSK is seeking a Scientific Director to lead safety evaluation and risk management for oncology assets in clinical development. You will shape safety strategy, drive risk mitigation, and partner across functions to protect patients and ensure timely, robust decision-making.

This hybrid role combines on-site governance with remote collaboration. You will mentor teams, present to safety review boards, and contribute to global regulatory safety documents while advancing innovative oncology programs

Qualifications

• Pharmacovigilance, drug safety and risk management experience.
• Strong ability to interpret clinical and safety data.
• Knowledge of global PV requirements and drug development processes.

Responsibilities

• Lead pharmacovigilance activities and risk mitigation strategies for oncology assets and trials.
• Drive evaluation and interpretation of safety data including signal detection.
• Develop strategic safety evaluation approaches within clinical development programs.
• Contribute to safety components of regulatory submissions (INDs, DSURs, IBs).
• Perform literature reviews, data synthesis and integrated safety analyses.
• Present safety recommendations to senior governance committees and external partners.

Skills

Pharmacovigilance

Safety data interpretation

Clinical judgement

Communication skills

Influencing stakeholders

Education

Bachelor of Science/PharmD/MD/PhD

Advanced degree (PharmD/PhD/MD)

Job description

Position Summary

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 is critical in shaping the safety strategy of innovative oncology therapies and directly impacting patient outcomes. The Scientific Director partners cross‑functionally to ensure high‑quality, timely decision‑making and proactive risk mitigation across the portfolio.

Key Responsibilities

• Scientific and Pharmacovigilance Leadership
• 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 programs
• 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 of outputs 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 and present at Safety Review Team (SRT) meetings
• Escalate emerging safety issues to senior leadership and governance bodies as appropriate
• Build strong working relationships and effectively lead within a global matrix environment
• Mentor and coach junior team members as applicable
• Communication, Influence, and Strategy
• Present safety recommendations and emerging risks to senior governance committees with clarity and impact
• 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 long‑term safety and clinical development strategies
• Drive continuous improvement by introducing innovative approaches to safety evaluation and processes
• Communicate complex scientific information effectively to diverse audiences

Basic Qualifications

• Degree in a health or life sciences discipline (e.g., Bachelor of Science, PharmD, MD, PhD, or equivalent).
• -5+ years experience in pharmacovigilance, drug safety, or related safety evaluation role in the pharmaceutical or biotech industry.
• Practical experience in signal detection, safety surveillance and risk management across clinical development and post‑marketing.
• Knowledge of global pharmacovigilance requirements and drug development processes.
• Strong clinical or scientific judgement with experience interpreting clinical and safety data.

Preferred Qualification

• Advanced degree (PharmD, PhD, MD) or equivalent clinical qualification.
• 10 or more years of pharmacovigilance or medical safety experience.
• Experience in preparing regulatory safety documents and participating in regulatory interactions.
• Experience leading safety activities in a specific therapeutic area relevant to the role.
• Demonstrated ability to lead and influence cross‑functional teams in a matrix setting.
• Experience supporting inspections, audits, and readiness activities.

Working Model

This role is hybrid, based in the United States. You will be expected on site for key meetings, governance activities and team collaboration. Remote working is supported to balance focused work and stakeholder engagement.

Skills

Digital Fluency, Enterprise Leadership, Influencing Without Authority, Pharmacovigilance, Presentation Techniques

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 $217,800 to $363,000. 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.

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• 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?

Unifying 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.

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We are 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 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. Find out more on our career site.