Associate Director, Clinical Scientist

Immunocore - Gaithersburg, MD

Full-time - Senior

Gaithersburg, MD

Professional, Scientific, and Technical Services

About the position

The Associate Director, Clinical Scientist at Immunocore is responsible for leading clinical development activities for assigned studies, contributing to clinical strategy, and ensuring compliance with regulatory standards. This role involves collaboration with internal and external stakeholders to design and execute clinical trials, analyze data, and mentor team members, all while fostering an inclusive and innovative work environment.

Responsibilities

• Develop study concept, including overall study design, schedule of assessments, objectives/endpoints, and eligibility criteria.
• Integrate feedback from internal and external stakeholders including senior leadership, key investigators, and regulatory agencies.
• Contribute to authoring of the study protocol and provide critical feedback and review of supporting documents; help to respond to health authority feedback.
• Provide protocol trainings to internal and CRO teams.
• Contribute to design of study-specific case report form (CRF) and ensure CRFs are aligned with study requirements during user acceptance testing.
• Ensure study manuals are aligned with the study protocol.
• Support successful collaborations with investigators, including conducting and participating in pre-site selection discussions, site initiation visits, and investigator meetings.
• Serve as clinical representative on internal and external meetings.
• Conduct and oversee real-time clinical data reviews, including oversight of CROs when applicable.
• Perform analysis and help to interpret clinical data, lead authoring of selected sections of clinical study reports.
• Provide expert, collegial support and leadership to achieve study and program objectives.
• Collaborate with Regulatory and Compliance to foster a compliant, high-quality, and inspection-ready culture.
• Contribute to continuous improvement and process development initiatives.
• Help to ensure deliverables and milestones are met within timelines and budget.
• Present program strategy and results to internal and external stakeholders; help to author congress abstracts/presentations and primary manuscript.
• Mentor and/or supervise clinical science contractors.

Requirements

• Requires at least 1 year of prior experience in the role of clinical scientist.
• Requires a PhD, PharmD, RN, or MD and 10+ years related experience or MSc/BSc degree with extensive (14+ years) role-specific equivalent experience.
• Understanding and experience in the processes of oncology drug development.
• Strong data analysis, data visualization, and communication skills, with ability to write clear, accurate, and concise documents.
• Able to safeguard patient safety in clinical studies, including identifying trends in AE and lab data.

Nice-to-haves

• Strong publication and presentation record.
• Experience supporting interactions with global health authorities.
• Background in immunology and experience developing immunotherapeutics.
• Experience working with CROs including providing oversight.
• Experience incorporating, implementing, and evaluating translational endpoints.

Benefits

• Competitive salary and performance bonuses.
• Health insurance coverage.
• 401k retirement savings plan with matching contributions.
• Flexible scheduling options.
• Professional development opportunities.