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Sr. Clinical Program Leader, Clinical Operations

South San Francisco
California, United States of America


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The Position

The Genentech Research and Early Development Sr Clinical Program Leader position is a key strategic leadership role accountable for evaluation of strategic options, development and delivery for assigned early development programs. The Sr. Clinical Program Leader helps define and implement vision and strategy for study management and is accountable for functional management including recruiting, building and maintaining a high quality Genentech Research and Early Clinical Operations.



Primary Accountabilities and Responsibilities:

Program Management Responsibilities:


Through appropriate leadership, direction and operational expertise, lead the development and execution of global operational strategies for multiple molecules/programs in Genentech’s early development portfolio:



Recognized as expert thought partner in drug development with thorough understanding of all aspects of clinical drug development

 

Core member and Clinical Operations representative on the Early Development Teams (i.e. Core, Development or Clinical Sub-Teams) serving as a primary consultant to senior-level colleagues, functional leadership and cross-functional stakeholders within and outside of Genentech Research and Early Development.

 

Makes broad contributions to the development of the clinical development plan, and establishes the operational strategy for new programs

 

Partners with late stage to ensure strategic alignment of Clinical Development Plan, country/site strategies, and planning of end-to-end lifecycle of molecule

 

Provides program leadership to global cross-functional teams across the Roche group (e.g. Affiliates, MSLs, etc) including external partners and vendors through oversight, guidance, strategies and direction to achieve results; 30-50% of time spent leading and managing through people

 

Provides innovative and flexible operational solutions and ability to understand, critically assess and influence global clinical development plans, protocol design, resource needs, global budgets and timelines for programs

 

Provides disease area expertise and input to the function and the TA while anticipating changes in the disease landscape (e.g. standards of care) and regulations that impact operational strategies

 

Accountable for meeting all operational deliverables in accordance with time, cost and quality commitments. Maintains an overview of status, risks, and proactively communicates progress, issues or changes that may impact timelines and costs of the program to all stakeholders including the Therapeutic Area leadership. Maintains internal consistency across studies within a program

 

Leverages internal resources pan-Roche to identify potential novel partnership opportunities to accelerate development of clinical programs while leveraging solutions, lessons learned and sharing knowledge broadly

 

Participates in Business Development/in-licensing assessments as requested, providing strategic input as well as operational elements in terms of costs, resources, and timelines

 

Leads Genentech Research and Early Development Clinical Operations Disease Teams and development of operational strategies across Genentech Research and Early

Development molecules. Provides disease area input and member of global disease teams in partnership with Product Development, Pharma Research and Early

Development, and Genentech Research and Early Development.



Functional Management Responsibilities:

Provide leadership, guidance, and manage the performance and development of 5-6 direct reports; administer performance programs in accordance with policies, and ensure the development of potential succession candidates. Additionally, the Sr. Clinical Program Leader role will contribute to the Clinical Operations organization. These responsibilities include:

 

Identify, recruit, and hire Clinical Operations Study Management staff, as well as oversee their work to ensure all department goals, deliverables and objectives are met

 

Identify and manage resource needs through proactive planning and effective recruitment

 

Ensure that employees are appropriately trained, developed and coached to comply with company policies and Global regulations

 

Participate in and/or lead working groups and/or business improvement efforts within the Genentech Research and Early Development organization to improve clinical trial processes, systems, methodologies, and tools

 

Participate in enterprise wide initiatives (as needed) to support and influence the future direction of the organization

 

Partner with Early Clinical Development Business Operations team to develop role-based competency and training strategies and programs

 

Partner with Early Clinical Development Informatics team to establish strategies and priorities in support of improving and advancing clinical trials

 

Advocate/drive/support goals and changes within the organization

 

Lead by example to create a positive work environment by encouraging mutual respect, innovation, smart risks and accountability on a functional and project level, both locally and globally, to help the organization to continuously evolve, improve and excel



Qualifications:

12+ years experience of clinical and drug development (or equivalent), including 5+ years of clinical trial management experience

 

2+ years of clinical program management experience

 

Functional management experience

 

Bachelor's Degree or equivalent required (scientific or healthcare discipline preferred).

 

Advanced degree preferred

 

Working knowledge of international regulatory and ICH Good Clinical Practice guidelines



Experience, Skills, Behaviors, Knowledge:

Proven ability to lead teams, form productive working relationships within and external to the department, using the skills of collaboration and influence in areas of problem solving

 

Demonstrated ability to work in a volatile, uncertain, complex and ambiguous environment and skilled at making quick and informed decisions with limited information

 

Substantial experience in organization, implementation, and delivery of global clinical programs

 

Demonstrated ability to manage larger-scale, cross-functional strategic projects, activities and teams; effectively formulate strategies, tactics and action plans to achieve results, and continuously move the business forward

 

Uses understanding of major business functions, industry trends, and own organization's position to contribute to effective business strategies and/or tactics

 

Meaningful analytical skills, including previous experience with forecasting, analyzing and interpreting benchmarking research results. Ability to analyze complex activities and information to arrive at reasonable conclusions

 

Identifies and leverages opportunities to accelerate results and build capability by assigning tasks and decision-making responsibilities to individuals or teams with clear boundaries, expectations, support, and follow-up

 

Demonstrated ability to think globally and apply creative solutions to problems without defaulting to status quo including welcoming diversity of thought to make decisions

 

Change leader with ability to drive, encourage and support innovation

 

Ability to think beyond own department, identifying connections between different areas of the organization to positively impact the business and its customers

 

Ability to set clear vision/strategies and removes obstacles for teams that are barriers to doing productive/high impact work

 

Demonstrated leadership, influencing, and motivational skills. Communicates with energy and passion, to engage and inspire others

 

Proven ability to coach, develop, manage performance, and mentor personnel



Other (e.g. Travel):

Willingness to travel domestically and internationally, and work across cultures.



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.

 

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.

#ClinicalTrials #ProgramManagement #GCP #Biotech #SFBayArea

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.


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