Director, Data Management NDC

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. 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 a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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. Join our team as we transform the lives of others.

Position Summary:

The Director, Clinical Data Management, will be responsible for all clinical data management activities and deliverables for the assigned compound(s) in accordance with ICH/Good Clinical Practices (GCP), GDCMP and other relevant regulations, procedures and guidelines. The responsibilities of this position include but are not limited to supervising junior data manager(s), vendor management, budget and contract negotiations and management, training and oversight for all data management deliverables and timelines from study start-up through study close-out, final reporting, and archiving.

The Director will drive for data standards and standardization in requirements and processes, manage and lead the ongoing practices under the guidance of the established DM requirements and processes in collaboration with internal study team and/or vendors.

The Director will provide leadership to building the effective CDM teams of the assigned program(s), driving engagement, and motivating staff to success.

The Director will also partner and collaborate with other functional groups and external vendors to ensure timelines and the quality of project deliverables.

Additionally, the Director will be responsible for staffing and resourcing the project group appropriately.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Manages program(s) and makes expert recommendations and/or decisions that assure timelines and deliverables of the studies
• Collaborates cross-functionally to resolve clinical data issues and ensure effective communication and leadership for strategic alignment throughout the drug development process
• Resolves and/or escalates issues encountered at the department level and improve the performance of the data management function
• Provides the highest level of CRO/vendor oversight to ensure requirements are met and the project plans are executed to meet the development needs
• Leverages data management and related expertise to promote best practices across the drug development lifecycle and enhances collaboration with relevant stakeholders
• Contributes to team building, standardization and best practice to achieve the defined data quality with cost efficiency
• Participates in regulatory audit and/or company initiatives
• Manages direct reports and project resource planning
• Manages study budgets of the assigned program(s)
• Responsible for performance of the function and the team member development for the assigned program(s)

Education and Experience:

Required:

• MS/BS in life sciences or related field
• 10 + years of direct data management experience and at least 3 years of managerial experience managing direct reports
• In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry 
• In depth knowledge and experiences in clinical trials in oncology and/or rare disease in endocrine disorder
• Proven supervisory and mentoring skills
• Strong project management skills and experiences working with CROs/vendors
• Demonstrated leadership quality and superior organizational and interpersonal skills 
• Detail oriented with excellent communication skills and extensive experiences working in cross-functional setting
• Highly knowledgeable and experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance
• Knowledge of GCP, ICH and other regional regulations and compliance
• Experiences with clinical data lifecycle from database set-up and maintenance to database lock and archiving
• Knowledge of current technologies in clinical trial data collection and data management systems.

Preferred:

• Knowledge in current d