Senior Director, Clinical Data Management

Categories: Biometrics
Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Come join our team as we transform the lives of others.
Position Summary:
The Senior Director, Clinical Data Management will oversee all data management activities associated with clinical drug development for all projects. Duties include Clinical Data Management (“CDM”) oversight including strategic resourcing, timeline planning, process improvement, data standardization development and implementation. The responsibilities of this position also include partnering and collaborating with other functional groups and external vendors to ensure timelines and quality of project deliverables. The individual will also provide leadership to the CDM group by leading organizational changes; developing and empowering staff; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement, and creating a climate where staff are motivated to do their best. The position will report directly to the VP, Head of Biometrics.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
  • Serve as the inter-department subject matter expert for the CDM area to enable planning, coordination, and timely delivery of complete, high quality, and reliable clinical trial data for internal decision-making, regulatory approval and market acceptance
  • Evaluate, implement and lead processes, infrastructure development and staffing to build the CDM function for the growing clinical pipeline, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards
  • Ensure compliance from a CDM perspective regarding protocols, SOPs and overall clinical objectives. Develop, review and update SOPs and process documentation in accordance with corporate, industry, and regulatory agency standards
  • Responsible for implementing the corporate strategic plan within the department, planning and managing internal and external CDM resources, and managing the department budget
  • Provide overall strategic, organizational, and operational management and guidance to the CDM group
  • Provide technical and functional oversight of the day-to-day work and work products of clinical data management staff, as needed, including clinical data collection, processing, and quality control procedures, timelines, and documentation
  • Select and manage data management vendors; identify potential risks and resolving issues with CROs; oversee vendor management plans and reviewing quality metrics; provide guidance, and monitor the progress of DM activities with CROs or other vendors
  • Oversee identifying, locating, evaluating and validating CDM documents and databases as required for report generation or regulatory submission
  • Assist with the coordination of non-routine projects, as applicable, in support of the Medical Sciences department
  • Collaborate with cross functional peers to facilitate and optimize the product development and registration process
  • Other duties as assigned
Education and Experience:
  • Bachelor’s degree in life sciences or equivalent, with at least 15 years of relevant data management experience and at least 10 years of managerial experience
  • Prior experience leading CDM infrastructure setup & deployment and CDM process improvement
  • Experience on CRO selection and oversight, as well as management experience in clinical trial data collection systems (EDC, eCOA, CTMS, Drug Safety Database Systems, IVRS/IXRS) and practical knowledge of data integration between data collection systems
  • Working knowledge of data standards in the clinical environment
  • In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry. 
  • Competence in SAS programming is a plus
  • Demonstrated leadership quality and superior organizational and interpersonal skills. 
  • Excellent written and verbal communication skills
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. 
Physical Demands and Work Environment:
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 25 lbs. may be required. The noise level in the work environment is typically 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.
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range:  $170,000 – $252,000
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.
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.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws
Vaccination requirement:
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.