Opportunity DetailsOn Assignment
Sr. Director Clinical ScienceRemote - US
Job Summary: The Senior Director of Clinical Science will report to the Chief Medical Officer or delegated Medical Director and will be responsible for providing strategic medical and scientific input and interpretation for various aspects of clinical studies and programs. This includes establishing medical/scientific processes for data curation, overseeing data reviews in conjunction with other key team members and company stakeholders to ensure data quality and integrity, collaborating with clinical operations on clinical trial delivery, and occasional travel to clinical sites and scientific congresses.
Key Responsibilities: - Develop and implement best practices in clinical science, including providing input into clinical protocols, Investigator Brochures, Clinical Study Reports and trial transparency notifications (e.g., clinicaltrials.gov), overseeing scientific and medical input into study plans (e.g., medical monitoring plan, data management plan, statistical analysis plans, safety and pharmacovigilance plans, clinical monitoring plans), participating in the review of safety committee data in conjunction with study medical monitors, and contributing to annual reporting deliverables. The role will also oversee and facilitate ongoing data review to ensure consistency with collection from sites.
- Participate in the development of protocols, informed consent, and other study materials
- Participate in the development and review of management plans for the study.
- Contribute to the planning and conduct of investigator meetings, training meetings, and site initiation visit documents and slides. Present aspects of the assigned studies at these meetings.
- Ensure timely and accurate study-related communication to internal and external study teams. Participate in study and project team meetings.
- Assist with the review and development of SOPs and related guidelines.
- Participate in the evaluation and selection of vendors to provide services for the Sponsor.
- Identify and escalate potential data or operational risks with suggested mitigation approaches to the study team.
- Contribute to the medical monitoring log, aspects of medical eligibility review, and frequently asked questions (FAQ) documents.
- In conjunction with Clinical Development Operations, ensure that investigators and vendors adhere to established clinical protocol, regulatory requirements, ICH/GCP, and provide input into data validation.
- Serve as a strategic resource for communicating with Investigators and study staff to help resolve issues with performance and clinical interpretation of protocols.
- Participate as a subject matter expert for medical and scientifically related questions about processes, systems, and data during inspections and due diligence exercises.
- Participate in the publication and presentation of study data.
- Contribute to other duties, as assigned.
Qualifications: - The incumbent will have a doctoral degree in a science-related field, preferably with a strong CNS background.
- Minimum 10-15 years of experience supporting clinical research trials in-house for a Biotech/pharmaceutical company or CRO.
- Ability to work independently and within a team-oriented environment with minimal supervision.
- Excellent interpersonal, written, and verbal communication skills.
- Ability to travel up to 10% of time to clinical sites/vendor partner sites and scientific congresses.
