The Clinical Program Director plays a lead role in developing Adamas clinical operations team and infrastructure for a given project(s). (S)He will provide strategic input 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 VP, Clinical Operations.
- Works closely with senior management or 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, recommend team roster assignments and team accountability (with approval from appropriate department head for the cross-functional trial team members)
- Develops and approve study protocols, case report forms, informed consent forms and other study-related documents
- Selects, manage and oversee 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 qualify investigational sites for participation in trials
- Manages and oversee all monitoring of clinical studies (internal and external)
- Collects and archive of all documents for inclusion in the Trial Master File
- Reviews and finalize 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;
- Develops clinical SOP’s in accordance with ICH and GCP guidelines in collaboration with Quality and Regulatory departments;
- Selects and train appropriate team members to ensure tasks are completed on time and within budget. Responsible for mentoring junior staff (Clinical Research Associates, Clinical Trial Assistant, etc) and/or be responsible for managing direct reports, as needed;
- Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.
- Minimum of a Bachelor of Science degree in a relevant scientific discipline;
- Minimum of ten years of related clinical management experience (CRO, biotech or pharmaceutical company) or equivalent combination of eduction, training and experience;
- 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 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;
- Successful experience in fast-paced entrepreneurial environment;
- Fit with Adamas culture and values.
To apply for this position please send your resume to email@example.com 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.