Executive Director, Clinical Operations at Rigel Pharmaceuticals, Inc. in South San Francisco, California

Job Description:

POSITION SUMMARY:

The Executive Director, Clinical Operations will report to the Vice President of Development Operations and function as a strategic leader of the Clinical Operations group, accountable for key high-level management, establishing new processes and procedures, and adherence to industry best-practices, Rigel SOPs, and applicable regulations and Good Clinical Practice (GCP). The Executive Director may maintain oversight of the operation of one or more clinical programs including project planning, budget, resource management, and management of contract research organizations (CROs) and other key vendors. This individual represents departmental and corporate management to ensure appropriate fiscal oversight, including management of vendor scopes-of-work and change orders, and recommends and implements innovative ideas to impact clinical trials management. The Executive Director oversees clinical trials staff both internally and at service providers and manages all aspects of study operations at both the project and the department levels. This role acts as a cross-functional leader to ensure study plans appropriately support research questions and other goals of the company and participates in development-wide discussions to resolve differences with other functional areas within Development. The Executive Director ensures a positive, collaborative team environment and escalates issues to the VP and other functional area Heads as appropriate.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible and accountable for defining clinical operating plans for development projects; manages resources, timelines and budgets for global clinical programs to ensure clinical and corporate goals are met or exceeded


• Oversees the identification, selection and management of external resources and vendors, from full service CROs to contract monitors


• Acts as an escalation path and general point of contact for CROs and other vendors as needed; represents the company on periodic vendor calls and ensures CRO and internal personnel adhere to project specifications with particular attention to timelines, costs, and quality of deliverables


• Oversees critical decision-making among key stakeholders including Rigel personnel, scientific advisers, and vendor representatives; escalates issues to the VP, CMO, and/or other functional area Heads appropriately; provides input to other functions in the organization and is responsible for identification, prioritization, and definition of new processes as organizational complexity expands


• Assists in the day to day management of the Clinical Operations team as well as training and development of this team (SOP's; GCP, ICH and federal regulations etc.); plays a key role in managing the growth of the Clinical Operations team, including the identification of resource needs, presentation of headcount requests to the CMO and HR representatives as needed, and leading the interviewing and on-boarding processes affecting direct reports and other Clinical Operations staff as required


• Supports creation of key study documents including study protocols, ICFs and applicable study plans both with other Rigel teams and vendors


• Ensures that participating investigators adhere to Good Clinical Practice and applicable regulations by ensuring timely review of monitoring visit reports by appropriate staff and participates in direct engagement with CRO personnel and Rigel Clinical Quality Assurance as needed; acts as a point of escalation for any significant compliance issues, and escalates issues as needed to the VP, CMO, and other functional area Heads for resolution


• Ensures that proper processes are adhered to regarding the initiation, conduct and closeout of all US run studies as well as the maintenance of the Trial Master File for such trials; takes personal responsibility for ensuring regulatory compliance and delivery of high-quality data via all appropriate means


• Supervises national regulatory and IRB/Ethics Committee submissions and responses to questions as required


• Reviews and contributes to Clinical Study Reports, INDs, NDAs, and other clinical and regulatory documents


• Represents the company as needed at professional meetings and presents clinical operations materials and provides training at such events as needed


• Provides leadership in the development and documentation of departmental policies and procedures toward increased efficiency and quality of deliverables; contributes directly to the development of SOPs and other procedural documents


• Develops, implements, and oversees mechanisms for appropriate reporting of the progress of clinical programs to the VP, CMO, and EC


• Direct supervision/management of assigned Clin Ops team members


• Acts as a mentor to all Clin Ops team members

KNOWLEDGE AND SKILL REQUIREMENTS:

• Bachelor's degree, preferably in a scientific or health-related discipline


• Minimum of 15 years of clinical and related experience with at least 8 years of clinical trial management experience in an industry setting such as a CRO or pharmaceutical company; trial management experience gained at academic or other not-for-profit institutions involved in industry-sponsored research may supplement this requirement at the discretion of the hiring manager


• Excellent understanding of Good Clinical Practice and FDA regulations; Ex-US regulatory knowledge/experience, particularly in Europe, is highly desired


• Clinical experience/background (e.g. RN, PA, or medical office) a plus


• Demonstrated ability to develop positive working relationships with individuals and teams both inside and outside the company


• Must have proficiency with MS Office as well as demonstrated ability to learn other project management and clinical trial software as required


• Demonstrated ability to work independently, escalate issues appropriately, and to ensure a solutions-oriented approach to the identification and mitigation of risks to project milestones, budgets, and quality

WORKING CONDITIONS:

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  PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.


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  WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required. Ability to travel approximately 10%-30%, depending on departmental needs.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any othercharacteristic protected by the law.