Job Description
What you'll be doing We are seeking a highly motivated
Director of Clinical Data Management (CDM) to lead study-level data management activities in support of our oncology clinical development programs. This individual will serve as the compound CDM lead for one or more clinical trials, responsible for the planning, execution, and oversight of data management activities in collaboration with internal stakeholders, including US/ex-US DM team and external partners (e.g., CROs, technology vendors).
This is an exceptional opportunity to contribute directly to the success of high-impact oncology trials in a dynamic and collaborative environment. The role will report to the Head of Clinical Data Management and may evolve to include line management responsibilities as the organization grows.
You will be responsible for...Study-Level Data Management- Serve as the primary data management lead for assigned clinical trials, ensuring timely, high-quality data deliverables throughout the data lifecycle.
- Develop and maintain study-specific data management plans (DMPs) and associated documents such as CRF completion guidelines, edit check specifications, and data transfer specifications.
- Oversee case report form (CRF) design, eCRF programming, and database setup activities in coordination with CRO partners and internal stakeholders.
- Coordinate and perform data review, query management, and data cleaning activities; support interim and final database lock processes.
- Ensure that data management practices are consistent with applicable regulatory requirements (e.g., ICH GCP, FDA) and industry best practices (e.g. GCDMP).
- Support the integration and reconciliation of external data sources, including central labs, imaging, biomarker, and other third-party data providers.
Cross-Functional Collaboration- Work closely with Clinical Operations, Biostatistics, Medical, and Regulatory Affairs to align trial objectives, timelines, and data expectations.
- Act as the data management point-of-contact during study planning, conduct, and closeout phases.
- Lead Data Working Groups and cross-functional data review meetings to ensure data quality is maintained throughout the study.
- Contribute to the development of clinical trial protocols and statistical analysis plans (SAPs) from a data management perspective.
Functional Vendor Oversight- Collaborate with and provide oversight of NUVB ex-US DM collaborators, CROs and third-party vendors, ensuring the quality and timeliness of deliverables.
- Participate in vendor selection and contracting activities; contribute to the development of vendor performance metrics.
- Ensure effective communication between vendors and internal teams to proactively address data-related issues.
Process and Quality Support- Contribute to the development and continuous improvement of data management processes, SOPs, and standards within the organization.
- Support regulatory inspections and audits by providing documentation and subject matter expertise as needed.
- May lead or participate in data-focused initiatives, such as implementing new data review tools and R shiny apps, standardizing data review workflows, or adopting novel data sources (e.g., ePRO, wearables).
Team Leadership- As the team grows, may provide mentorship or line management to junior CDM staff or contractors.
- Participate in training, onboarding, and professional development of new team members
What Knowledge & Experience you'll bring to us...- Bachelor's degree in life sciences, data science/statistics/math, computer science, health informatics, or related field required; advanced degree preferred.
- 8+ years of clinical data management experience in the biotech, pharmaceutical, or CRO industry.
- 3+ years of experience managing people, vendors, and functional teams.[LF1]
- Strong leadership, strategic thinking, and communication skills
- Strong working knowledge of clinical data systems (preferably Medidata Rave) and CDISC standards (SDTM, CDASH).
- Experience managing third-party vendors and overseeing outsourced data management activities.
- Thorough understanding of GCP, ICH, and relevant regulatory guidelines.
- Comfortable working in a fast-paced, hands-on environment with the ability to pivot as priorities evolve. Prior experience working in a small biotech or startup environment is highly desirable.
- Familiarity with complex data types (e.g., imaging, genomics, digital endpoints) in oncology trials is desirable.
- Demonstrated ability to balance strategic thinking with hands-on execution.
- Experience supporting regulatory submissions (e.g., NDA, BLA) is a plus.
[LF1]need a little more emphasis on leadership as this hire is a little different than the hire a year ago.
Behavioral skills to be successful...- Problem-Solver - As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
- Emotional intelligence, curiosity, and a knack to figure out a way to build something better
- Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
- Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
- Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.
What we have for you! - Competitive Base Salary, Bonus, and Equity Plans
- Unlimited Vacation and 10 Sick Days Annually
- Excellent Medical, Dental, and Vision Coverage
- 401K with Company Matching
- and much more!
The base pay offered will take into account internal equity and also may vary depending on the candidate's job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
DisclaimerThis job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Note to all external Recruiters & Staffing AgenciesAll of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.
