Sr. Director Clinical Science

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.
• Oversight and facilitation of ongoing data review to ensure consistency with collection from sites.
• Participation in the development of protocols, informed consent, and other study materials.
• Development and review of management plans for the study.
• Contribution to the planning and conduct of investigator meetings, training meetings, and site initiation visit documents and slides. Presentation of aspects of the assigned studies at these meetings.
• Timely and accurate study-related communication to internal and external study teams. Participation in study and project team meetings.
• Assistance with the review and development of SOPs and related guidelines.
• Evaluation and selection of vendors to provide services for the Sponsor.
• Identification and escalation of potential data or operational risks with suggested mitigation approaches to the study team.
• Contribution to the medical monitoring log, aspects of medical eligibility review, and frequently asked questions (FAQ) documents.
• Ensuring adherence to established clinical protocols, regulatory requirements, ICH/GCP, and providing input into data validation.
• Serving as a strategic resource for communicating with Investigators and study staff to help resolve issues with performance and clinical interpretation of protocols.
• Contributing to the publication and presentation of study data.
• Performing other duties as assigned.

Qualifications

• 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.