Job Title:
Director/Senior Director, Clinical Data Management
Reports to:
Vice President, Clinical Operations
Location:
Redwood City, CA
Classification:
Exempt
Overview:
The Director/Senior Director, Clinical Data Management will lead and oversee clinical data management activities across all phases of drug development. This role will be responsible for building and managing a high-performing data management function, ensuring data integrity, compliance, and timely delivery of high-quality clinical trial data in support of regulatory submissions and clinical development goals across all assets in development.The ideal candidate brings a strong background in data strategy, vendor oversight, team leadership, and hands-on experience in biotech or pharmaceutical environments.
Key Responsibilities:
- Provide strategic leadership and operational oversight for all clinical data management activities across multiple programs and therapeutic areas.
- Propose and implement continual improvements in methodology, technology, and study process procedures.
- Serve as critical SME when vendor selection of CROs and data vendors for EDC, ePRO and/or IRT are required.
- Ensure that all clinical databases are developed, tested, locked, and archived according to regulatory requirements and timelines.
- Collaborate closely with Clinical Operations, Biostatistics, Clinical Science, Translational Medicine, Regulatory, and Pharmacovigilance teams to ensure seamless data flow and integration.
- Contribute to protocol and CRF design, including case report form review and data collection strategy.
- Manage internal data management staff and mentor junior team members; contribute to the growth and structure of the Data Management department.
- Represent Data Management in cross-functional meetings and interactions with regulatory authorities, as needed.
- Stay current on evolving industry standards (e.g., CDISC, SDTM, ADaM) and regulatory requirements (e.g., FDA, EMA, ICH GCP).
Qualifications:
- Bachelor’s degree in Life Sciences, Health Informatics, or related field; advanced degree preferred.
- Minimum of 15 years of clinical data management experience, with at least 5 years in a leadership role.
- Minimum of 7 years experience in immune-oncology, including early phase clinical trials.
- Strong knowledge of EDC systems (e.g., Medidata Rave, Oracle InForm), clinical data standards, and regulatory submission requirements.
- Proven experience managing and developing internal teams as well as external vendors and CROs.
- Excellent communication, organizational, and strategic planning skills.
- Ability to thrive in a fast-paced, dynamic, and collaborative biotech environment.
- Hands-on experience with FDA/EMA regulatory submissions preferred.
- Familiarity with tools in data cleaning or analytics is a plus preferred.
The Base Salary Range for this position is $190,000 to $260,00. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.** We are currently not accepting any unsolicited resumes from recruiters or employment agencies. **
