Associate Director, Clinical Scientist

Immunocore - Rockville, MD

Full-time - Senior

Rockville, MD

Professional, Scientific, and Technical Services

About the position

The Associate Director, Clinical Scientist will execute and lead clinical development activities for one or more assigned studies, acting as the leader on assigned study teams and departmental initiatives. This role is critical in contributing to the development of the clinical strategy, which includes developing awareness of the competitive landscape and aligning with the wider company strategy. The position is based onsite and can be located at either of the US locations in Conshohocken, PA or Rockville, MD. In this role, the Associate Director will be responsible for developing the study concept, which encompasses the overall study design, schedule of assessments, objectives and endpoints, and eligibility criteria. They will integrate feedback from various stakeholders, including senior leadership, key investigators, and regulatory agencies. Additionally, the Associate Director will contribute to the authoring of the study protocol and provide critical feedback and review of supporting documents, as well as assist in responding to health authority feedback. The Associate Director will also provide protocol training to internal teams and Contract Research Organizations (CROs), contribute to the design of study-specific case report forms (CRFs), and ensure that CRFs align with study requirements during user acceptance testing. They will oversee real-time clinical data reviews, identifying trends in safety and efficacy data, reviewing Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs), and assessing protocol compliance, escalating issues to the Medical Monitor when necessary. Moreover, the Associate Director will perform analysis and interpretation of clinical data, lead the authoring of selected sections of clinical study reports, and provide expert support and leadership to achieve study and program objectives. They will collaborate with Regulatory and Compliance teams to foster a compliant, high-quality, and inspection-ready culture, adapt to changes in regulatory requirements, and contribute to continuous improvement initiatives. The role may also involve presenting program strategy and results to stakeholders and mentoring clinical science contractors.

Responsibilities

• Develop study concept, including overall study design, schedule of assessments, objectives / endpoints, and eligibility criteria.
• 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, identifying trends in safety and efficacy data, reviewing SAEs and AESIs, and assessing protocol compliance.
• 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, adapt to changes in regulatory requirements, and improve SOPs and work instructions.
• Contribute to continuous improvement and process development initiatives.
• Help to ensure deliverables and milestones are met within timelines and budget.
• May present program strategy and results to internal and external stakeholders; may help to author congress abstracts / presentations and primary manuscript.
• May mentor and/or supervise clinical science contractors.

Requirements

• Understand the principles of GCP and their applications to own work.
• Understanding and experience in the processes of oncology drug development.
• Strong data analysis, data visualization, and communication skills, with the ability to write clear, accurate, and concise documents, construct informative figures, and present to diverse audiences.
• Experience contributing to core study documents.
• Able to safeguard patient safety in clinical studies, including identifying trends in AE and lab data, reviewing SAEs and AESIs, developing risk mitigation strategies, and understanding when to escalate to the Medical Monitor.
• Self-motivated; demonstrated success in delivering assigned tasks according to timelines.
• Demonstrated history of creative problem-solving and learning agility.
• Effective collaboration with and ability to impact and influence cross-functional teams and, in selected situations, senior leaders.
• Successful in fast-paced environments with the ability to effectively manage multiple tasks and competing priorities.

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.
• Experience integrating clinical and translational data to support dose selection.

Benefits

• Health insurance
• 401k
• Paid holidays
• Flexible scheduling
• Professional development
• Tuition reimbursement