South San Francisco
California, United States of America
The Associate Director (AD) of Clinical Operations will provide strategic direction and leadership to the assigned therapeutic area(s) (TA) and other bodies on the Clinical Operations aspect of the portfolio and programs, which may include Patient Engagement, Biosample Operations, Process and Systems. Additional accountabilities include the oversight and delivery of all Clinical Operations activities, concerning all programs within the assigned TA(s) for USMA.
In this role, the AD of Clinical Operations will be a standing member of the USMA Evidence Generation Leadership Team and Medical Network Leadership Team(s) relevant to the assigned program responsibilities. The incumbent will also manage a team of direct reports, which may include Clinical Program & Study Leaders, Administrative Associates and contingent workforce employees.
All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business.
In this position, you will be primarily accountable for consistently, effectively:
Leading, managing and developing your direct reports
Guiding and ensuring expert clinical operations input into relevant USMA Medical Plans to support USMA medical strategy execution and overall success across the assigned therapeutic area(s)
Overseeing and guiding USMA clinical programs and associated clinical studies operations across the assigned therapeutic area(s), and assuming accountability for such, to ensure delivery of clinical operations activities to meet study plans outlined by medical plans.
Providing direction and leadership to USMA Clinical Operations teams dedicated to assigned therapeutic area(s); includes ensuring appropriate CRO and other vendor oversight
In partnership with Alliance and Advocacy Relations team in Government Affairs, develop and maintain relationships with Patient Thought Leaders to support patient engagement strategies and maintain a network of patient advocacy alliances (e.g. sites, networks, cooperative group partnerships) aligned with the needs of the current and emerging portfolio
Ensuring USMA Clinical Operations teams and vendor partners deliver on commitment to agreed targets
Ensuring study adherence to budget, ICH-GCP standards, Genentech/Roche Standard Operating Procedures (SOPs) and other operating guidelines and regulatory requirements
Ensuring USMA Clinical Operations teams for the assigned therapeutic area(s) compliantly develop and cultivate productive relationships with external partners/stakeholders
Ensuring that risk and quality plans are robust, proactive and implemented for all studies and related activities across the assigned therapeutic area(s)
Driving study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvement
Driving clear decisions in the project team environment
Ensuring the assigned USMA Clinical Operations team meets or exceeds assigned goals and objectives
Aligning, motivating and inspiring your team to work in accordance with broader Roche, Genentech and Medical Affairs strategies and goals
Hire, develop, and oversee the work of your direct reports
Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer-term
Act as part of the U.S. Medical Affairs (USMA) Clinical Operations Leadership Team and play a key role in cross-therapeutic planning and decision-making
Develop/lead organizational design, resource requirements, compensation, expense budgets, as well as immediate, medium and long-term capacity for the assigned USMA Clinical Operations function and team
Provide vision and strategic direction to your team
Therapeutic Area Management:
Act as the primary interface to USMA senior management (Medical Unit Heads, Group Medical Directors) and Product Development Medical Affairs (PDMA) counterparts to ensure alignment and high performance of clinical trials in your therapeutic area(s) of responsibility
Contribute functional expertise to the development of the therapeutic area (TA) strategy, both within the TA Medical Unit(s) and USMA Clinical Operations
Ensure that the TA strategy is shared, supported and implemented within the Clinical Operations function and the TA
Provide leadership and strategic guidance on the development and implementation of clinical trials including:
Delivery of program level activities to the TA from USMA Clinical Operations
Timely and accurate input into USMA plans, including forecasting of timelines, assessment of feasibility for protocol design, estimation of resources, and TA budget
Review and approval of the consolidated full-time equivalent (FTE) and program operational budgets for the TA
Identification of operational efficiencies across molecules within the TA
Identification of TA risks; proactively creating and implementing mitigation strategies.
Oversight of USMA Clinical Program Leaders/Study Management Teams (SMTs) with leadership and assistance in issue resolution ensuring SMT success.
Provide oversight to USMA Clinical Operations teams in vendor review, selection and issue escalation management
Effectively collaborate with Research and Early Development (REDs) groups (gRED/pRED) and PD colleagues for input and information exchange to ensure success of clinical programs
Actively participate in cross-functional governance reviews for TA-related discussions (both projects and strategies) to increase quality, productivity and efficiency
Directly manage USMA Clinical Program Leaders (CPLs) and Clinical Trial Leaders (CTLs) and provide therapeutic area specific leadership, guidance, clinical trial management expertise and direction to USMA Clinical Operations teams to achieve results:
Responsible for ensuring timely and optimal allocation of resources to projects
Ensure that your direct reports are trained and proficient in the incorporation of company Standard Operating Procedures (SOPs) and ICH/GCP guidelines for clinical program execution
Provide timely and direct feedback to functional managers for team members working in a matrix environment
Work with other Clinical Operations Leaders to manage the overall function and to standardize approaches, and increase the productivity and efficiency of clinical operations program management
Participate in and/or lead management meetings to plan and implement operational activities to increase quality, productivity and efficiency of the Clinical Operations function
Facilitate functional initiatives and participate in USMA cross-functional development activities
Participate in the development of Clinical Operations’ standards, processes and training
Review and approve expense and other administrative reports/forms as appropriate
Problem Solving & Decision Making:
Problem solving and decision making accountabilities may range from functional to broader Evidence Generation business related activities
Interaction with Others:
USMA Clinical Operations Leadership Team
Medical Unit(s) Leadership Team (respective to assigned therapeutic areas)
Biostatistics Business Units
Contract Research Organizations (CROs)
Management of Others (complete only if applicable):
The incumbent will also manage a team of direct reports, which may include Clinical Program & Study Leaders, Administrative Associates and contingent workforce employees.
Position Dimensions (complete only if applicable):
Previous Experience Required or Preferred in Related Field (time)
10 or more years’ experience in a leadership role in pharmaceutical/biotechnology research and development
4 or more years’ people management experience
2 or more years’ experience in medical affairs is preferred
Experience in managing large budgets
Global trial experience is required
Knowledge, Skills and Abilities
Comprehensive knowledge of ICH-GCP and other relevant standards and guidelines
Comprehensive knowledge of operational aspects of clinical trial management and the drug development process
Knowledge of relevant therapeutic area(s) is preferred
Expertise in the assigned therapeutic area(s) or ability to quickly learn scientific area
Bachelor's Degree in a medical/science-related discipline
Graduate or high-level degree in relevant disciplines is preferred
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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