Senior Director, Clinical Scientist - Late Stage Oncology Clinical Development

Job Details: Senior Director, Clinical Scientist - Late Stage Oncology Clinical Development Full details of the job.
Vacancy Name: Senior Director, Clinical Scientist - Late Stage Oncology Clinical Development
Vacancy No: VN519
Employment Type: Full Time
Location of role: Gaithersburg, MD
Conshohocken, PA
Oxford, UK
Department: Clinical Development
Key Responsibilities: Execute and lead late-stage oncology clinical development activities for multiple pivotal trials, from study concept through registration. Help establish and execute a cross-functional data cleaning strategy for late-stage programs. Drive development of clinical strategy, integrating deep understanding of the wider company strategy and the competitive landscape. Act as a strategic leader with the organization, leading complex programs and initiatives. Recruit, mentor, and line manage a team of late-stage clinical scientists. Develop study concept, including overall study design, schedule of assessments, objectives/endpoints, and eligibility criteria. Author and oversee writing of the study protocol and provide critical feedback and oversight for authoring of supporting documents; respond to health authority feedback. Provide and oversee protocol trainings to internal and CRO teams. Lead design of study-specific case report form (CRF), ensure CRFs are aligned with study requirements during user acceptance testing, and author study-specific sections of the CRF completion guidelines. Ensure study manuals, etc. are aligned with the study protocol and broader company-wide templates. Build and maintain successful collaborations with investigators, including conducting and participating in pre-site selection discussions, site initiation visits, investigator meetings, and advisory boards. Serve as clinical representative on internal and external meetings. Work cross-functionally with clinical development, data management, clinical operations, and biostatistics to establish a data cleaning plan for each late-stage study. Coordinate and oversee real-time clinical data reviews (including oversight of CROs when applicable), including identifying trends in safety data, reviewing SAEs and AESIs, and assessing protocol compliance, escalating to Medical Monitor when appropriate. Oversee and coordinate analysis and interpretation of clinical data for key sections of clinical study reports, marketing applications, and other internal/external communications. Contribute to publication strategy; may lead authoring of congress abstracts/presentations and primary manuscript. Provide expert, collegial support and leadership to all members of the drug development team to ensure full success of the company's portfolio objectives and regulatory milestones. Collaborate with Regulatory and Compliance to foster a compliant, high-quality, and inspection-ready culture, adapt to changes in regulatory requirements, and improve SOPs and work instructions. Identify opportunities for continuous improvement and lead process improvement initiatives. Establish best practices and ensure a consistent approach is used across studies and teams. Foster cross-functional collaboration and develop potential solutions to study issues that may impact budget, resources, and/or timelines; escalate issues to senior leadership as appropriate. Present program strategy and results to internal and external stakeholders. Accountable for ensuring all study deliverables and milestones in the assigned Program are met with quality and within timelines. Periodic travel (~15-20%) to participating study sites as well as between Immunocore sites will be required (including overnight and international travel). Attendance of leading industry meetings as required. Supervisory Responsibility: Oversee direct report(s) to ensure quality and compliance of their work. Provide direction, mentoring, and support. Promote an environment that values initiative, experimentation, and freedom of action. Build hope, optimism, excitement, and a positive work atmosphere that motivates the team to achieve stretch goals and tackle challenges. Use advanced coaching techniques to grow and develop employees. Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets. Develop resourcing strategy, with support from Business Planning and Operations, to ensure late-stage oncology clinical scientist capacity can support projected demand based on current and projected clinical pipeline projects. Education, Experience and Knowledge: Essential Qualifications: Requires at least 5 years of prior experience in the role of a clinical scientist. Requires a PhD, PharmD, RN, or MD and 15+ years of work experience or MSc/BSc degree with extensive experience. Understand GCP, applications to own work, and oversight responsibilities. Deep understanding and extensive experience in the process and strategy of late-phase oncology drug development. Excellent data analysis, data visualization, and communication skills, with proven ability to write clear, accurate, and concise documents, construct informative figures, and present to diverse audiences. Demonstrated ability to deliver high-impact presentations and publications. Extensive experience and expertise in authoring of core study documents. Experience supporting interactions with global health authorities. Thorough understanding of how to safeguard patient safety during the conduct of clinical studies and experience in identifying and responding appropriately to emerging safety signals. Expertise in managing direct reports with ability to mentor and develop colleagues from a variety of backgrounds and with different competencies. Demonstrated success in motivating teams to deliver assigned milestones. Demonstrated history of creative problem-solving and learning agility. Demonstrated ability to lead cross-functional teams, listen to and integrate input, and work closely with senior leadership. Strong interpersonal skills with the ability to drive and influence decision-making. Experience with CRO oversight and management. Successful in fast-paced environments with ability to effectively manage multiple tasks and competing priorities. Desirable Qualifications: Experience with immuno-oncology. History of significant contribution to successful marketing applications. About the Company: Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases, and autoimmune disease. Our leaders in R&D are internationally recognized as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.
Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases, and autoimmune diseases.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
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