SERM Scientific Director

GSK; Waltham (MA); On-site; USD 170,000 - 283,000; Full time

Benefits offered by this job

Health care

Retirement benefits

Paid holidays

Parental leave

Long-term incentive program

Job summary

GSK is seeking a Scientific Director to provide advanced safety evaluation and risk management for oncology assets in clinical development. You will lead pharmacovigilance activities, evaluate safety data, and guide risk mitigation strategies within a global framework.

The role emphasizes cross‑functional leadership, regulatory submissions, and proactive safety decision‑making to protect patients and advance portfolio goals.

Qualifications

• Degree in a health or life sciences discipline (e.g., Bachelor of Science, PharmD, MD, PhD, or equivalent).
• Minimum 5 years experience in pharmacovigilance, drug safety, or related safety evaluation role.
• 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.

Responsibilities

• 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.

Skills

Pharmacovigilance

Risk management

Signal detection

Regulatory submissions

Education

Health/Life sciences degree

Job description

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 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

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

• 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 decisionsContribute 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).
• Minimum 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.

Skills

• 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 $169,950 to $283,250. 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.

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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.