The Clinical Program Director plays a critical role in developing and managing the clinical operations team and infrastructure for a given project(s). This position will provide strategic and operational leadership and drive the planning and execution for assigned clinical trials with direct responsibility for time, cost, quality and risk mitigation. This position is based in Emeryville, CA and reports to the Vice President, Clinical Operations.
- Works closely with senior management & key stakeholders to assist with the overall clinical strategy consistent with Project Team goals;
- Translates clinical trial concepts into protocols and study execution plans;
- Leads the clinical trial(s) team with overall responsibility for the tactical implementation of trial timelines, study timelines, milestones and budget in collaboration with the Project Team; May be the clinical sub-team leader for a given program.
- Develops study management plans, recommends team roster assignments and team accountability (with approval from appropriate department head for the cross-functional trial team members)
- Develops and approves study protocols, case report forms, informed consent forms and other study-related documents
- Selects, manages and oversees CROs and other vendors to ensure that clinical studies are executed properly, on time and in compliance with GCPs
- Oversees clinical supplies management for a specific project (including initial supply, ongoing management and returns and destruction)
- Reviews and qualifies investigational sites for participation in trials
- Manages and oversees all monitoring of clinical studies (internal and external)
- Collects and archives all documents for inclusion in the Trial Master File
- Reviews and finalizes clinical study reports and other applicable reports authored by clinical team members for submission to regulatory agencies
- Ensures appropriate systems for inventory, tracking/accountability (handling, storage, return, documentation, etc.) of investigational product are in place and in compliance with all applicable regulations
- Identifies quality issues within the study to implement appropriate corrective action plans;
- Serves as primary internal and external clinical operations project contact (eg CRO or vendor) to ensure communication is maintained and timelines are achieved;
- Assists with the development of clinical SOPs in accordance with ICH and GCP guidelines
- Selects, trains and mentors appropriate team members to ensure tasks are completed on time and within budget. Responsible for line management of junior staff (Clinical Research Associates, Clinical Trial Assistant, etc.);
- Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.
- Minimum of a Bachelor’s degree in a relevant scientific discipline, Graduate Health or Scientific degree preferred;
- Minimum of 10 years of related clinical management experience (CRO, biotech or pharmaceutical company) or equivalent combination of education, training and experience;
- Previous experience of line management with a proven record of employee development;
- In depth knowledge of and skill in applying pharmaceutical regulatory requirements and the impact on development of clinical trials, specifically, knowledge of 21 Code of Federal Regulations Title 21 Parts 11, 50, 54, 56, 312, 314; International Conference on Harmonization Guidelines E6 (Good Clinical Practice: Consolidated Guidance), E2A, E8 and Guidelines from other Regulatory Authorities pertinent to planned studies;
- Thorough knowledge of planning, implementing, and managing single and multi-center clinical trials is required. CNS experience is preferred and international study experience is a plus;
- Able to break down assigned work into manageable process steps that ensures maximum efficiency of self and others. Can effectively manage multiple and changing priorities;
- Strong written and verbal communication, interpersonal, problem solving and negotiation skills. Can prepare appropriate documentation and materials in final draft that are clear and convey the desired message;
- Adept at cross-functional team management and strategic program planning;
- Proven ability to organize, take initiative and follow-up independently;
- Excellent presentation skills: ability to present to all levels (internal and external);
- Proven organizational skills; ability to manage multiple priorities and work under pressure;
- Ability to travel as needed, up to 20%
- Successful experience in fast-paced entrepreneurial environment;
- Fit with Adamas culture and values.
To apply for this position please send your resume to firstname.lastname@example.org with the job title in the subject line. Principals only, no recruiters please.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.