Senior Director, Clinical Data Management

This is a fully remote position, open to applicants in California.

📋 Description

• Act as a senior strategic partner for functional leaders, aiding in program-level planning, risk management, and execution strategies.

• Collaborate with Clinical Operations, Biostatistics, Medical, Regulatory, Safety, and Quality teams to pinpoint and address data-related challenges that affect timelines, quality, or compliance.

• Establish data management vendors as necessary, which includes drafting RFPs, reviewing, and negotiating budgets and contracts for data management.

• Monitor database status concerning key performance indicators, metrics, and program deliverables to support project timelines.

• Oversee data review, cleansing, and database lock activities to ensure precision and readiness for analysis and regulatory submissions.

• Proactively identify vendor-related risks, escalate issues when required, and lead root-cause analyses and corrective actions.

• Balance quality, timelines, and costs while implementing practical solutions that align with program priorities.

• Cultivate a culture of accountability, collaboration, and ongoing improvement among internal teams and external partners.

• Provide direct oversight and periodic evaluations of departmental employees' work to ensure adherence to clinical development timelines.

• Lead and mentor a team of data management professionals.

• Promote a collaborative atmosphere that fosters innovation and knowledge sharing.

• Ensure effective resource allocation and management across research departments.

• Drive performance and accountability through clear communication of expectations and objectives.

• Support organizational growth by enhancing data management capabilities and processes as the portfolio evolves.

⛳️ Requirements

• A Bachelor's degree is required; a Master's degree in Life Sciences or a related field is strongly preferred.

• At least 12 years of experience in clinical development within the pharmaceutical or biotechnology sectors, with significant experience as a hands-on clinical data management lead. A minimum of four years in management within pharmaceutical development is preferred.

• A solid understanding of drug development processes, FDA regulations, and ICH GCP guidelines, along with extensive knowledge of the pharmaceutical industry and the execution of global clinical studies.

• Proven leadership and people management experience, demonstrating a successful track record of leading cross-functional and international teams and influencing senior leaders across various functions.

• Experience in managing clinical data management vendors, contractors, and service providers to ensure the successful delivery of program objectives and timelines.

• Strong analytical capabilities with proven experience in gathering, interpreting, and analyzing clinical research and drug development data to inform decision-making and risk management.

• Exceptional communication, presentation, and stakeholder management skills, with the ability to distill complex data and risks into clear, business-relevant insights.

• Knowledge of FDA and ICH GCP guidelines to guarantee the proper conduct of clinical studies is essential.

🏝️ Benefits

• Medical, dental, and vision coverage

• Life insurance

• Disability insurance

• 401(k) savings plan

• Flexible spending accounts

• Employee assistance program

• Tuition reimbursement program

• Voluntary benefits such as group legal

• Critical illness coverage

• Identity theft protection

• Pet insurance

• Auto/home insurance

• Time off in accordance with the sick time policy

• Flexible vacation policy

• Parental leave policy