Associate Director, Clinical Operations

Categories: Clinical Operations
POSITION SUMMARY:
The Associate Director, Clinical Operations directs the planning, execution, monitoring, and completion of one or more clinical development programs or projects. The Associate Director interacts with Contract Research Organizations (CROs), external physician investigators, other contracted service providers, and all levels of internal staff, including Non-Clinical Development, Clinical Sciences, Biostatistics and Data Management, Clinical Trial Materials Supply, Regulatory, Quality Assurance, Project Management, Finance and Legal. The Associate Director also serves as a member of the Clinical Operations management team, contributing to departmental polices and SOPs, project and staffing plans, and the like. This role reports to the Director, Clinical Operations.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These responsibilities may include, but are not limited to:
  • In collaboration with internal and external scientific and medical experts, plan and execute clinical trials to support clinical development strategies and plans; participate substantially in the development of a wide variety of critical trial documents, including clinical trial synopses, protocols, case report forms, investigator brochures, and the like; manage internal teams to review and approve clinical study reports in accordance with overall project timelines
  • Organize investigator and expert meetings relevant to the indication and assist with the organization and management of DSMBs and Data Review Committees
  • Lead global clinical studies and provide strategic and tactical planning, organization, direction, and tracking for completing studies within project Timelines
  • Develop request-for-proposals documents and solicit and evaluate bids; lead contracting process with selected CROs, collaborating with relevant departments such as Legal and Finance
  • Manage CROs to execute clinical trials in accordance with contracted scope, costs, and timelines and within budget; actively engage with CROs on defining, monitoring and reporting on all aspects of key trial performance indicators, including country and site initiation activities, patient screening and randomization rates, and data collection activities
  • Prospectively identify budget, timeline, and quality risks, proactively communicate risks to management team, internal stakeholders and CRO teams, and bring team together to develop and implement risk mitigation strategies and tactics to enable trials to complete on budget, per specified timelines, and with high-quality data and deliverables
  • Plan and manage project finances in accordance with the Company’s strategic and operating plans and Finance policies
  • Assist in preparation and review of regulatory filings/submissions including protocols, IND/IMPD submission documents and NDA/MAA submissions
  • Lead blinded data review activities in collaboration with data management and other cross functional team members
  • Write, review and participate in the preparation of clinical documents (e.g. protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards, Standard Operating Procedures, guidelines and departmental policies)
  • Assist in safety monitoring and data management activities
  • Collaborate with the senior management team to ensure consistency across the clinical trial portfolio, as necessary
  • Lead, direct, manage, develop, coach and evaluate direct reports and other employees in group in accordance with the Company’s Human Resource policies and plans
  • Act in accordance with general Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by employees in reporting and other departments
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
  • Minimum BS in biological sciences or related discipline with at least 10 years of related experience. (an equivalent combination of experience and education may be considered)
  • Minimum of five (5) years of direct clinical study management experience required
  • Prior experience managing others 
  • Prior experience managing CROs and other external service providers on a global scale is a must
  • Knowledge of GCPs, ICH guidelines and FDA regulations; familiarity with EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus
  • Prior experience with the preparation of NDAs and MAAs and other regulatory documents is highly desirable
  • Excellent writing skills as they relate to preparation of regulatory documents
  • Excellent interpersonal skills with strong oral/written communication and presentation skills
  • Experience in managing external service providers and consultants
  • Demonstration of a broad-based and cross-functional understanding of the drug development process
  • Excellent time management skills and ability to mentor junior staff in time management
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).  Prior experience with electronic systems such as EDC, TMF, CTMS and IWRS required. 
 
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
 
The Anticipated Base Salary Range: $120,000.00 – $175,000.00
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown in December.
 
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
 
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.