Senior Director, Clinical Operations

Company: Crinetics Pharmaceuticals, Inc
Location: San Diego
Posted on: June 25, 2022

Job Description:

You can consent to the use of such technologies by using the "Accept" button, by closing this notice, by interacting with any link or button outside of this notice or by continuing to browse otherwise. Position:Senior Director, Clinical Operations Location: Remote or San Diego, CA
Job Id:369 # of Openings:1 POSITION SUMMARY: The Senior Director of Clinical Operations will assist the VP in overseeing the performance and management of Crinetics' clinical programs, ensuring GCP and regulatory compliance, and managing the Clinical Operations team. (Position will be filled at level commensurate with experience) ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These may include but are not limited to:

• Direct and oversee clinical programs to ensure compliance with regulatory requirements, adequacy of data acquisition and management, and timely completion of studies and associated projects
• Identify and communicate project objectives, propose innovative solutions to potential obstacles, and ensure adequate resources are in place to successfully complete clinical projects and programs on-time, on-budget, and with highest-quality deliverables
• Actively participate in development of clinical protocols and program timelines
• Evaluate CROs for their ability to execute clinical trial work, compare budgets and timelines, and make recommendations to senior management; oversee preparation of requests-for-proposals and facilitate bid defense meetings with potential vendors
• Coordinate with departmental and corporate management to ensure appropriate fiscal oversight, including management of vendor scopes-of-work and change orders
• Monitor enrollment activities and ensure optimal subject recruitment for each project; Liaise with patient advocacy groups to positively impact patient recruitment as needed
• Oversee vendor and site qualification activities in conjunction with Clinical Quality Assurance
• Oversee management and maintenance of Trial Master Files for all Crinetics' clinical trials
• Provide guidance on all logistics associated with execution of clinical studies (including clinical supplies, sample shipments etc.)
• Provide ongoing assessment and feedback on departmental policies and procedures toward increased efficiency and quality of deliverables. May contribute to the development of SOPs and other procedural documents ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
  • May be responsible for mentoring junior staff and/or direct supervision and line management
  • Other duties as assigned EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
    • BS in biological sciences or related discipline with at least 12 years of experience working in the biotechnology/pharmaceutical industry (an equivalent combination of experience and education may be considered)
    • Prior experience managing third parties and external service providers (worldwide) and consultants is a must
    • In-depth experience with drug development issues
    • Excellent writing skills as they relate to the preparation of clinical and regulatory documents
    • Excellent interpersonal skills with strong oral/written communication and presentation skills
    • Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved
    • Experience in managing teams (including external service providers and consultants)
    • A good understanding of GLPs, GCPs, and ICH Guidelines
    • Leadership and management skills, and, demonstrated qualities in this area
    • Demonstration of cross-functional understanding related to drug development
    • Good judge of risks and a keen ability to analyze options and manage outcomes
    • Familiarity of Regulatory Affairs as applicable to clinical data and report filings
    • Well versed with the latest trends in the clinical trial industry TECHNICAL KNOWLEDGE REQUIRED: Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Software Knowledge: Windows, MS Office (Outlook, Word, Excel). EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. TRAVEL: Travel may be required up to 25% of your time ABOUT CRINETICS: Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine and endocrine-related cancer therapeutics company. Crinetics' benefit package includes health insurance, stock options, a 401k, paid time off, and the company provides a dog-friendly work environment.

Keywords: Crinetics Pharmaceuticals, Inc, San Diego , Senior Director, Clinical Operations, Executive , San Diego, California