Executive Director, Early-Stage Clinical Development, Autoimmune

Full details of the job.

Vacancy Name

Vacancy Name Executive Director, Early-Stage Clinical Development, Autoimmune

Vacancy No

Vacancy No VN679

Employment Type

Employment Type

Full Time

Location of role

Location of role Gaithersburg, MD, Conshohocken, PA, Remote, US, Oxford, UK, Remote UK

Department

Department Clinical Development

Key Responsibilities

Key Responsibilities The Executive Director, Early-Stage Clinical Development, Autoimmune will drive assigned autoimmune programs from pre-clinical stages to proof of concept. They will also contribute to the development of infrastructure within Immunocore’s Clinical Sciences department by leading designated projects and work streams. As the assets develop into the clinic, the incumbent will build a small team.

The successful candidate will spearhead Clinical Development strategic planning and be responsible for the design and medical oversight of assigned clinical studies. This includes protocol development, medical monitoring, medical data review, results interpretation, reporting, and regulatory submissions. Additionally, they will lead innovation in trial design, including the development of biomarker strategies. The incumbent is expected to think strategically at both the program and enterprise levels, with the ability to analyze data, troubleshoot programs, and develop risk mitigation plans
As a key in-house autoimmune disease expert for R&D, this role requires strong strategic leadership, advisory skills, and close collaboration with cross-functional teams whilst providing oversight, guidance, and mentorship to junior physicians working in early-stage clinical trials.

The Executive Director will interact with all levels of management, peers, and leaders from academic centers involved in key collaborations, as well as external stakeholders in the medical and scientific community and global regulatory authorities. The incumbent will work with outstanding people who together pioneer the research, development and commercialization of bi-specific immune modulating therapies.

Key Responsibilities

Apply deep knowledge of the treatment landscape and emerging areas to shape future clinical development strategies and plans for assigned studies and portfolios. Collaborate closely with Project Leaders, Research, Translational, Regulatory, Clinical Operations, Biostatistics, and Clinical Pharmacology colleagues.
Use extensive drug development expertise to design comprehensive clinical development plans, including key decision points, timely readouts, and risk mitigation for both near and long-term goals. Hold clinical matrix team members accountable for achieving clinical objectives.
As the Clinical Development Program Leader, provide strategic clinical leadership to development teams. Generate integrated product development plans that incorporate scientific rationale, regulatory input, competitive landscape, project and portfolio strategy, and advice from patient advocacy groups.
Coordinate and achieve highly complex program objectives through applying advanced expertise, proactively anticipating issues, and developing mitigating solutions. Understand the impact these objectives have on broader corporate strategy.
Design high-quality and innovative clinical trial protocols (including supporting documents such as Investigator’s Brochure and informed consent) for lead autoimmune programs aligned with the Clinical Development Plan and overall product strategy.
Establish and maintain strong relationships with key opinion leaders and partners to facilitate ongoing clinical development, external collaborations, and gather insights into Immunocore programs.
Oversee medical aspects of clinical studies, including implementation, medical/safety monitoring, medical data review, results interpretation, and reporting for assigned studies.
Build and manage relationships with relevant CROs, facilitate a thorough understanding of clinical studies, assist in patient recruitment, and ensure trials are executed on time and within budget.
Partner with Regulatory Affairs to lead regulatory strategy, prepare and…