Therapeutic Area Director, Clinical Operations

South San Francisco
California, United States of America


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The Position

Therapeutic Area Accountabilities

The Clinical Operations Therapeutic Area Director is a key strategic senior leader accountable for the evaluation of strategic options, development and delivery of the Early Clinical Development Clinical Program portfolio for assigned therapeutic area/s.

  • Accountable for driving and overseeing assigned TA portfolio. May be assigned approximately 3 Therapeutic Areas, in up to 8 indications across 10 molecules
  • Sets 3-5 year vision and strategy for comprehensive Clinical Operations Therapeutic Area Strategies that positions the overall assigned portfolio for long-term success
  • Strategic thought partner with the gRED Clinical Science TA Heads and Medical Group Directors in the development of high quality, efficient and innovative clinical programs
  • Provides direct leadership and oversight of Associate Director and Sr. Clinical Program Leaders in the development of Clinical Development Plans and Target Product Profiles
  • Leads and mobilizes the creation of innovative global operational strategies incorporating patient-centric approach, effective alliances, data, and technology to support acceleration of drug development in assigned TA areas
  • Accountable for establishing and monitoring high performance standards and metrics for assigned portfolio
  • Directs and influences the activities of approximately 30+ direct and indirect reports through Associate Directors and Senior Managers
  • Provides leadership and portfolio direction to CRO alliance partners as extension of internal team (gRED dedicated Global CRO team 100+ FTEs – include Vice Presidents, Directors, Project Managers and Clinical Trial Monitors)
  • Accountable for assigned portfolio project variable and headcount costs; develops accurate assumptions and prudent allocation of resources
  • Serves as a principal spokesperson for Clinical Operations in governance review bodies such as the Development Review Committee (DRC) and provide technical expertise in the development of Clinical Development Plans (CDPs)
  • Chair internal Clinical Operations Governance Review Committees
  • Strategic thought partner with other functional Therapeutic Area Heads within gRED (e.g. Project Team Leaders, Project Management, Development Sciences, and Research) and other functions in Product Development (PD) that support the gRED portfolio (e.g. Data Management, Biostatistics, Regulatory, Drug Safety and others)
  • Creates effective partnerships with PD stakeholders to ensure efficient transition of gRED molecules to PD Late-Stage organization
  • Actively engage and partner with stakeholders across the Roche organization on therapeutic area level operational strategies to ensure collaboration and cooperation across multiple Clinical Operations organizations within Roche (PDG, pRED, USMA and PDMA)
  • Partner with ECD Informatics team to identify needs and priorities for data (application of Artificial Intelligence and Machine Learning) and technology innovation that support the long-term needs of the assigned gRED portfolio
  • Partner with the Head of Alliance and Partnership group to identify current and future needs in vendor and site alliances within assigned TA area
  • Partner with the Portfolio Management group for all life cycle management activities supporting the assigned portfolio
  • Partner with Quality and Compliance Office to identify and mitigate quality and compliance risks
  • Assess different operating models to incorporate new and novel approaches to planning and execution of clinical programs

Organizational Leadership

As part of the Clinical Operations Leadership team, the Therapeutic Area Director participates in setting and implementing the vision and strategy of the Clinical Operations organization. 

  • Accountable for talent development and succession planning for Associate Director and Senior Clinical Program Leaders
  • Provide leadership and direction to the Clinical Program Leadership team to develop and manage Clinical Trial Leaders
  • Plans for talent needs over the long term to develop next generation Clinical Operations leaders
  • Provide input for group capacity planning of Clinical Program Leaders and Clinical Trial leaders with a time horizon of 1-3 years
  • Co-accountable in the creation and management of Clinical Operations functional budget
  • Co-accountable for creating and driving a transparent, highly motivating and innovative culture within Clinical Operations and ECD Operations
  • Develop efficient, scalable system and approaches to planning and implementing clinical trial operations that effectively integrate clinical operations and other functional areas
  • Partner with the ECD Applied Operations team to establish training strategies and priorities to support clinical trial excellence
  • Champion and sponsor functional initiatives to proactively identify new opportunities to leverage Clinical Operations core competencies, and develop ways to improve clinical trial processes, systems, methodologies, and tools
  • Lead or participate in corporate-wide initiatives to support and influence the future direction of the organization
  • Embrace and model Roche/GNE Leadership Commitments and Clinical Operations Operating Commitments to help the department continuously evolve, improve and excel
  • Ensures that employees are appropriately trained and comply with company policies and Global Regulations

Requirements:

Minimum:

  • 14+ years experience of clinical and drug development, including 4+ years of clinical program management experience
  • 8+ years direct line management experience
  • Previous experience in managing a group
  • Substantial experience in biotechnology and/or pharmaceutical clinical research with responsibilities for major aspects of strategic planning, organization, implementation, and delivery of clinical programs
  • Bachelors Degree or equivalent required (scientific or healthcare discipline preferred).  Advanced degree strongly preferred. (Candidates with comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.)

Skills, Knowledge and Expectations

  • Demonstrated ability to lead and mobilize global unit and teams
  • Sustained record of outstanding performance and accomplishments in drug development
  • Strong financial, contractual acumen and negotiation skills
  • Ability to distill complex issues and ideas down to simple, comprehensible terms
  • Strong executive leadership presence and confident in challenging senior management
  • Strong stakeholder management skills - proactively influence and share expertise with other areas of the company to positively impact their business issues
  • Visionary and forward-thinker
  • Takes a long term view and makes plans for acquiring the skills and expertise needed to support the business today and in future
  • Embraces and demonstrates diversity and inclusion
  • Strong problem solving skills with the ability to adapt to unique situations and points of view, flexes style and arguments to influence the right decisions
  • Maintains progress, focus and morale in the face of uncertainty or ambiguity
  • Outstanding change management skills and a proven track record of effectively driving organizational change and innovation
  • Thrives in a fast-pace and high pressure environment

Other (e.g. Travel): Willingness to travel domestically and internationally, and work across cultures

*LI-gRED-KM2

Who We Are

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.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.


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