Data Management Opportunity – Onsite 5 days
The Associate Director/Director, Clinical Data Management (CDM) is an experienced leader with strong knowledge of Clinical Data Management concepts and processes. This position supports the strategic and operational execution of CDM activities across clinical studies Phase I to IV, contributing to the management of internal FTEs, FSP resources, and fully outsourced studies across geographic regions.
This position is expected to represent CDM and Data & Statistical Sciences in a leadership capacity. The role requires strong partnership and close collaboration with functional and matrix leaders across the R&D organization to ensure the successful, efficient, high-quality, and compliant delivery for the portfolio area.
This is an onsite role. NEED TO BE ONSITE all 5 days a week in East Bay region of the SF Bay Area.
Responsibilities
- Strategic leadership accountabilities include advancing capability development and contributing to the shaping of organizational structures across a growing and complex functional portfolio.
- Delivers strong leadership to employees within areas of responsibility. Leads coaching and development of employees, including manager-level individuals across the function.
- Represents the CDM department in cross-functional discussions and steps in for the Head of CDM as needed. Leads and participates in discussions with senior R&D colleagues to strengthen coordination across functions and sectors. This position has direct interface with key stakeholders and influencers across R&D, including Therapeutic Areas, Functional Leaders, and partner functions such as Information Technology, Strategic Sourcing & Procurement, and others.
- Aligns with Business, Functional, and TA teams on key portfolio objectives and priorities to inform and influence the strategy and direction of CDM. Engages with R&D colleagues and therapeutic or functional area leaders to execute on organizational priorities, with a focus on delivering quality CDM outcomes.
- Demonstrates strong organizational ability to manage CDM workload across therapeutic areas, ensuring appropriate resource allocation is in place for optimal portfolio support. Leads vendor engagement and utilization strategies with the ability to influence vendor capacity in line with portfolio demand.
- Leads the continuous development and refinement of innovative operating models, driving process optimization within CDM and sponsoring initiatives that create impact across functions and sectors. Works with the Head of CDM to ensure departmental strategy and processes are clearly communicated to all stakeholders, aligning priorities to maximize organizational effectiveness and productivity. Oversees development of performance metrics and ensures team adherence to standards and compliance.
- Attracts, develops, and retains top talent while building an engaged, empowered, and high-performing team grounded in company values. Drives cross-functional leadership engagement to develop new service capabilities, represents CDM externally as a functional expert, and fosters a positive, customer-focused culture where employees take pride in their roles and deliverables.
Qualifications
- Bachelor’s, Masters or PhD degree in related discipline 12-15 years as lead clinical data manager in biotechnology, pharmaceutical or health related industry.
- Experience in Oncology clinical trials is preferred.
- Experience leading or contributing to major change initiatives is preferred.
- Demonstrated experience leading global data management teams is required.
- Experience participating in regulatory submissions and inspections is required.
- A minimum of 8-10 years of line management experience is required.