This position involves collaborating with cross-functional teams, in close partnership with Study Responsible Physicians/Clinical Leads, to design, plan, and manage complex clinical trials, ensuring compliance with departmental, company, and regulatory standards
- This role contributes to the clinical development plan and drives the development of clinical trial protocols and materials and supports the completion of clinical study reports and regulatory filings
- As a core member of the clinical team, the Director, Clinical Science / Sr
Clinical Science Group Leader leads matrix interactions among cross-functional members, contributes to the evaluation of scientific opportunities, medical data monitoring, and drives process improvements to enhance trial efficiency and operational excellence
- This role may also manage direct reports, mentor colleagues, and foster a culture of continuous learning and development within the team
Drive clinical development strategy, contribute to the development of other study-related materials (e.g. ADP, SAP, CSR outputs, case report forms, operational plans) and provide clinical representation for study-related review committees (e.g., first in human committee, protocol review committee)
- Lead the execution of clinical trial protocols within the clinical development program, ensuring compliance with scientific, organizational, and regulatory standards
- Oversee end-to-end delivery of clinical trial protocols/programs, including study design, initiation, medical safety data monitoring, data dissemination, and closeout activities
- Manage and coordinate activities with internal functional partners and external partners to ensure timely scientific and clinical execution of clinical studies
- Maintain the quality and integrity of clinical data critical to the evaluation of study endpoints
- Interact and collaborate with investigators and study teams during the conduct of the trial(s)
- Lead training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes
- Review, interpret, and report clinical trial data, ensuring accuracy and integrity for health authority submissions
- Draft documents for reporting clinical trial data (e.g., clinical study reports, patient narratives, investigator brochures, and periodic safety updates)
Collaborate with Study Responsible Scientist and Study Responsible Physician to assess and evaluate clinical trial medical/safety data (i.e. adverse events, labs, medications, etc.). Establish and define medical data review plan in partnership with Study Responsible Physician
- Leads and performs medical data monitoring/reporting and evaluates ongoing clinical trial data
- In partnership with Study Responsible Physician, act as a liaison between the company and clinical investigators, fostering collaborations with key opinion leaders and external advisors
- Develop and maintain credible relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO, ARO)
- Provide mentorship and training to junior team members, fostering a collaborative work environment
- Guide and support colleagues in clinical development processes and standards
- Identify opportunities for process improvements and drive the implementation of best practices in clinical trial execution
- Drive innovative research methods and operational strategies to enhance clinical development efficiency
- Collaborate with cross-functional partners to align clinical strategies with overall product development goals
- Participate in governance meetings, as appropriate, and cross-functional initiatives to promote business strategies and process improvements
- Prepare and present findings and results of clinical research at internal and external meetings, including regulatory body interactions and academic partners
- May act as an author for scientific publications, as applicable, to influence clinical development practices and advancements
- Research and review medical literature and new technologies to support operational planning and scientific strategy implementation
Integrate scientific and technological innovations into clinical trial designs, including biomarkers and digital health initiatives
