# Director, Clinical Scientist **Company**: GSK **Work arrangement**: hybrid **Experience**: senior **Job type**: full-time **Salary**: $189,750 to $316,250 **Category**: Healthcare **Industry**: Healthcare **Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Director--Clinical-Science---Oncology-Clinical-Development_449285-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_0181e8da-ba2 ## Description The Director, Clinical Scientist 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 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 **Detailed Responsibilities:** **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 **Why You?** - Bachelor’s degree in life sciences or related scientific discipline required - 5+ years of 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 **Preferred Qualifications** - 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) - Oncology or immuno-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 **What we value** We act with transparency, respect and integrity. We welcome different perspectives and champion inclusion. Bring curiosity, humility and a clear focus on patients. **Ready to apply?** If you want to help shape clinical development and make a real difference for patients, we would like to hear from you. Please submit your resume and a short cover letter describing your relevant experience and why this role matters to you. We welcome applicants from all backgrounds and are committed to inclusion. **Skills** Analytical Thinking, Business Acumen, Change Management, Clinical Research, Clinical Trial Designs, Communication, Decision Making, Fostering Collaboration, Influencing Without Authority, Leadership, Matrix Leadership, Mentorship, People Management, Risk Management, Strategic Thinking ## Skills ### Required - Analytical Thinking - Business Acumen - Change Management - Clinical Research - Clinical Trial Designs - Communication - Decision Making - Fostering Collaboration - Influencing Without Authority - Leadership - Matrix Leadership - Mentorship - People Management - Risk Management - Strategic Thinking ### Nice to have - Advanced degree (e.g. MS, PhD, PharmD) - Clinical development experience across multiple phases of development (Phase I–IV) - Oncology or immuno-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 --- Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Director--Clinical-Science---Oncology-Clinical-Development_449285-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)