Director, Clinical Data Management

Nuvation Bio; United States; On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Unlimited vacation

10 sick days annual

Excellent medical, dental, vision

401K with company matching

Job summary

Nuvation Bio is seeking a Director of Clinical Data Management to lead study-level data management across oncology programs. You will act as the CDM lead for multiple trials, coordinating CRF design, eCRF programming, data transfer specs, and database setup with CROs and internal partners.

This role reports to the Head of CDM and may evolve to line management as the organization grows. The position requires 8+ years in clinical data management, strong leadership, and experience with Medidata

Qualifications

• 8+ years of clinical data management experience in biotech/pharma/CRO.
• 3+ years of experience managing people, vendors, and functional teams.
• Strong leadership, strategic thinking, and communication skills.
• Strong working knowledge of clinical data systems and CDISC standards (SDTM, CDASH).
• Experience managing third‑party vendors and outsourced data management activities.
• Thorough understanding of GCP, ICH, and regulatory guidelines.
• Startup/biotech environment experience desirable.
• Familiarity with complex data types in oncology trials is desirable.
• Experience supporting regulatory submissions is a plus.

Responsibilities

• Serve as the primary data management lead for assigned clinical trials, ensuring timely, high-quality data deliverables.
• Develop and maintain study-specific data management plans (DMPs) and related documents.
• Oversee CRF design, eCRF programming, and database setup with CROs and internal teams.
• Coordinate data review, query management, and data cleaning; support database lock processes.
• Ensure data management practices comply with regulatory requirements and industry standards.
• Support integration of external data sources (labs, imaging, biomarkers).
• Lead Data Working Groups and cross-functional data reviews.
• Contribute to protocols and SAPs from a data management perspective.

Skills

Leadership

CDM leadership

Regulatory knowledge

Vendor management

Medidata Rave

CDISC standards (SDTM, CDASH)

Data management

Education

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Tools

Medidata Rave

Job description

Who We Are… Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.

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.
• 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.

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.

Disclaimer

Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

This 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.