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Position Summary

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. We're uniting science, technology, and talent to get ahead of disease together. You will lead clinical development activities that advance oncology programs from early studies through regulatory interactions. You will work closely with cross functional teams, external experts, and leadership to design studies, interpret data, and shape clinical strategy. We value clear judgment, collaborative leadership, and a focus on patient safety. This role offers growth, meaningful impact, and alignment with GSK's mission.

Location Requirements

We require an on site office based presence 2 to 3 days a week in the US (Waltham, MA or Upper Providence, PA), UK (London or Stevenage), Switzerland (Zug), Poland (Warsaw) or Canada (Mississauga, ON).

Responsibilities

- Provide clinical leadership for study strategy and design (Phase I-IV), ensuring consistency with the CDP, asset profile and regulatory expectations.
- Lead protocol development from concept to final study report, authoring and reviewing the Clinical Study Proposal (CSP), Investigator's Brochure (IB) and clinical sections of regulatory submissions.
- Ensure study objectives, endpoints and safety monitoring meet regulatory, ethical and medical governance standards; establish and monitor Go/No Go criteria.
- Integrate internal and external scientific evidence to shape strategy and interpret findings.
- Lead clinical matrix teams and collaborate with Clinical Operations, Biostatistics, Clinical Pharmacology, Safety/Pharmacovigilance, Regulatory Affairs and other stakeholders to deliver studies on time,



with quality and within budget.
- Provide clinical input to regulatory interactions and submissions, prepare briefing materials and support regulatory meetings.
- Oversee clinical safety reporting, support DSURs and expedited reporting, and coordinate responses to Ethics Committees/IRBs and IDMCs.
- Drive clinical interpretation for CSRs, publications, abstracts and external presentations; represent programs externally when required.
- Contribute to process improvements that enhance study quality, efficiency and data integrity.
- Define clinical elements of protocols and present at governance forums.
- Ensure protocol and study documentation reflect input from internal and external experts and uphold patient safety.
- Participate in eCRF design/UAT and advise on analysis and reporting plans.
- Lead in stream data reviews, interim analyses and IDMC interactions as needed.
- Provide clinical leadership at Investigator Meetings and for site communications.
- Support publication strategy and external scientific engagement activities.

Basic Qualifications
- Master's degree in a life science, medicine or equivalent with relevant clinical research experience.
- Demonstrable oncology or immuno oncology clinical development experience across early and late phases.
- Proven matrix leadership and the ability to influence cross functional stakeholders.
- Knowledge of UK/EU regulatory frameworks (MHRA, HRA, EMA) and international submission processes.
- Solid clinical judgement,



data interpretation skills and effective communication across governance and external audiences.
- Minimum 2 years of clinical scientist experience (oncology preferred).

Preferred Qualifications
- Experience with immuno oncology or advanced oncology modalities and biomarkers.
- Experience with clinical pharmacology, translational medicine or evidence generation planning.
- Experience driving change, improving processes, and adopting new approaches to study delivery.
- Advanced clinical degree (MD, PhD, PharmD, RN) or equivalent senior clinical research experience.
- Experience with regulatory submissions, Scientific Advice/EoP2 interactions, and safety governance committees (IDMC/ISRC).
- Publication record and conference presentation experience.

Compensation and Benefits

The annual base salary for new hires in the US ranges $189,750 to $316,250 depending on the location within the US market. The position offers an annual bonus and eligibility to participate in share based long term incentive programs. Benefits include health care, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. The salary in Poland ranges from PLN 472,500 to PLN 787,500 gross. Depending on the role and internal policies, the position may also be eligible for a bonus and other rewards. All statutory benefits are maintained in accordance with local law.

EEO Statement

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, military service or any basis prohibited under federal, state or local law.

Apply on Kit Job: kitjob.ca/job/2fsod2

📌 Clinical Development Director, Oncology (Mississauga)
🏢 GlaxoSmithKline
📍 Mississauga