New · posted Nov 12
GSK · Pharmaceuticals
Director, Clinical Science – Oncology Clinical Development GYN
- Waltham, MA
- Hybrid
- Full-time
- Director
The role
For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.
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
Cancer is unrelenting, but so are we. At GSK, we are committed to transforming outcomes for people with cancer through innovative science, bold ambition, and strong partnerships across the healthcare ecosystem. We focus our science where it can matter most—advancing care in cancers with high unmet need, grounded in a deep understanding of disease biology and deliberate scientific choices that connect discovery to meaningful impact in the real world.
The Director, Clinical Science – Oncology Clinical Development GYN provides scientific leadership across defined components of study design, conduct, data review, and interpretation within an assigned clinical programme. Reporting to the Clinical Development Lead (CDL), this role operates within the asset-level clinical strategy and contributes scientific depth and rigour to the execution of the Clinical Development Plan (CDP).
The Director, Clinical Science partners closely with the Senior Scientist and cross-functional teams to support delivery of clinical studies, ensuring scientific quality, data integrity, and robust interpretation of clinical data. This role contributes to both study-level activities and broader programme insights, without holding accountability for asset-level strategy or overall study delivery.
This is a scientific individual contributor role requiring deep oncology clinical development expertise, strong analytical and collaboration skills, and the ability to operate effectively within a complex, matrixed environment.
In This Role You Will:
- Provide scientific leadership across defined components of study-level activities, including protocol development, study design, data review, and interpretation, within the strategic direction set by the CDL
- Serve as a core member of the Clinical Matrix Team (CMT), ensuring scientific alignment across study objectives, timelines, and deliverables
- Provide scientific insight to the CDL and Senior Scientist to inform asset-level strategy, benefit–risk assessment, and programme-level decision-making
- Ensure the scientific quality and consistency of key clinical and regulatory documents, including protocols, Investigator’s Brochures, Clinical Study Reports, and submission materials
- Apply scientific and clinical expertise to analyse and interpret data, ensuring rigour, integrity, and relevance to the target patient population
- Engage with internal and external stakeholders, including investigators and Key External Experts, to support study execution and scientific exchange
- Contribute to a culture of scientific excellence, innovation, and continuous improvement within Oncology Clinical Development
What you need
Basic Qualifications
· Bachelor’s degree in life sciences or related scientific discipline required
· Experience in pharmaceutical/biotechnology industry or related clinical development experience, with a focus on oncology
· Experience in clinical development from early stage through to regulatory submission, including study design, protocol authoring, and data review/interpretation
· Experience working within GCP, ICH, and global regulatory guidelines
· Experience authoring or contributing to clinical study proposals, protocols, Investigator’s Brochures, informed consent forms, clinical study reports, and regulatory submissions
· Experience working within cross-functional matrix teams and contributing to clinical decision-making
· Proven track record of working with investigators, site staff, external experts, CROs, and vendors.
Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations• 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 $189,750 to $316,250. 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.
Preferred Qualificationsnice to have
If you have the following characteristics, it would be a plus:
· Advanced degree (e.g. MS, PhD, PharmD) strongly preferred in life sciences or a related discipline
· Clinical development experience across multiple phases of development (Phase I–IV)
· GYN Oncology clinical development experience.
· Experience presenting or preparing materials for Protocol Review Boards, governance meetings, or scientific forums.
· Knowledge of regulatory requirements to support registration, including experience contributing to IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, or AdCom submissions.
Working Arrangement
This role is hybrid. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days.
What you'll do
Study Design and Execution
- Provide scientific input into protocol development and study design, ensuring robustness, feasibility, and alignment with CDP-defined objectives and regulatory requirements
- Author or co-author key study documents (e.g., Clinical Study Proposals), contributing to preparation and presentation at governance forums such as Protocol Review Boards
- Support study conduct by addressing scientific questions, ensuring data integrity, and maintaining alignment with protocol and regulatory standards
- Provide scientific input into study-level decisions related to protocol implementation and study conduct, within the strategic framework defined by the CDL
- Present and support the scientific rationale and study design at Investigator Meetings and respond to scientific inquiries from study sites
- Support implementation of study-level Go/No-Go criteria aligned to the asset-level decision framework defined by the CDL
Data Generation, Analysis, and Interpretation
- Analyse and interpret clinical data to generate insights on safety, efficacy, and patient populations
- Integrate data from internal and external sources (e.g., literature, competitor data, emerging science) to inform study and programme understanding
- Provide scientific input into data review and interpretation activities, in collaboration with Medical Directors and pharmacovigilance
- Translate study findings into clear scientific insights to inform programme progression and support CDL-led decision-making
Clinical and Regulatory Deliverables
- Contribute to development of clinical and regulatory documents, including protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and submission materials
- Ensure scientific accuracy, consistency, and quality across study documentation
- Support preparation of regulatory submissions and responses to Health Authority queries
- Contribute to regulatory reporting requirements (e.g., DSURs, INDSRs) and ensure alignment with regulatory standards
Cross-Functional Collaboration & Scientific Contribution
- Serve as a core member of the CMT, partnering with Clinical Operations, Statistics, Safety, Regulatory, and Medical Affairs to support integrated study delivery
- Provide scientific expertise to cross-functional discussions, including integrated evidence planning and disease-area forums, as appropriate
- Participate in internal and external scientific interactions with investigators, Key External Experts, advisory boards, and collaborators
- Contribute to scientific communications, including publications, congress presentations, and study-related materials
Ways of Working & Continuous Improvement
- Identify scientific and operational risks at the study level and provide input into mitigation strategies
- Support and drive implementation of consistent ways of working and process improvements across the programme
- Participate in Oncology Clinical Development initiatives and workstreams to strengthen standards, processes, and capabilities
- Engage in ongoing development to deepen scientific expertise, expand disease-area knowledge, and build broader clinical development capabilities
Pay and benefits
$189,750 – $316,250 a year
Employer providedAnnual bonus
Share-based long-term incentive program
Health care and insurance benefits
Retirement benefits
Paid holidays and vacation
Paid caregiver/parental and medical leave
Where you'll work
Waltham, MAHybridOpen in Maps (opens in a new tab)
More jobs in Waltham, MA
From the posting
About GSK
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 - [email protected]
Equal opportunity, accessibility and legal noticesGSK's statements, word for word
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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.
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 16% below the US median for Clinical Development roles at this level.
This roleEmployer provided
Director roles in Massachusetts65 roles publishing pay
Director roles in the US222 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $189,750 | — | $316,250 |
| Massachusetts (middle half) | $253,000 | $300,000 | $323,500 |
| All US (middle half) | $255,000 | $300,000 | $335,500 |
This role: GSK's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 295 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not GSK's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 47 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct21
- Collaboration and leadership14
- Documentation and SOPs9
- Investigations and CAPA6
- Regulatory submissions5
- Lab testing and methods3
- Quality systems and risk3
- Data and digital systems2
- GMP and compliance1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Development work in pharmaceuticals, led by the three this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
Company hiring pulse
GSK on Regulatory Jobs
- 38
- Open roles
- 38
- Distinct roles
- 8
- Locations
By discipline
- Clinical19 50%
- Quality14 37%
- Regulatory5 13%
By level
- Director20 53%
- Associate & Specialist8 21%
- Manager4 11%
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Director, Clinical Science – Oncology Clinical Development GYN at GSK
Applications close November 26. $190K–$316K a year, employer provided.