Join a Team that Lives to Improve Lives
Genentech's Early Clinical Development team has opportunities available for senior level clinical program leaders based in South San Francisco, CA. These are strategic leadership roles for experienced program leaders with a passion for developing molecules in the areas of oncology (cancer immunotherapy experience preferred) or OMNI (includes neurology, respiratory and ophthalmology).
Sr. Clinical Program Leader
The Genentech Research and Early Development (gRED) Senior Clinical Program Leader (Sr CPL) position is a strategic leadership role accountable for leading clinical trial leaders and programs with passion in a highly dynamic and innovative environment. The Sr. CPL is collaborative and takes smart risks to accelerate development of the gRED pipeline.
As a member of assigned gRED molecule Core Teams, Development Sub-Teams and Clinical Sub-Teams, the Sr CPL represents Clinical Operations across gRED and contributes to the development of the strategic plans for assigned programs. The position is accountable for oversight and delivery of all operational activities in accordance with the Clinical Development Plans (CDPs), and for functional management including recruiting, building, and maintaining a best-in-class gRED Clinical Operations organization.
Program Management Responsibilities:
- Contributes to the development of the target product profiles, CDPs including scenario planning, high-level forecasting of timelines, assesses program level feasibility, estimation and allocation of resources and budget, and development of high-level operational strategies. Handles unique challenges and decisions that have an impact on function and disease area. Communicates initial budget, resource, risks and timelines to review bodies, and subsequent changes, as appropriate.
- Accountable for meeting all operational deliverables in accordance with the timeline, cost and quality commitments. Maintains an overview of status, issues, and proactively communicates progress, issues or changes that may impact timelines and costs of the program to all stakeholders. Maintains internal consistency across studies within a program and ensures alignment of operational program to the development team’s goals.
- Operates at strategic level including input into risk management plans, business value assessment and therapeutic area/indication expertise. Long-range Planning horizon is typically 1-3 years.
- Serves as a primary consultant to senior-level colleagues (eg, Clinical Sub-Team Leaders, Development Sub-Team Leaders, Project Team Leaders, Group Medical Directors and Development Review Committee Chairs), functional leadership and cross-functional stakeholders within and outside of gRED. Work is performed in partnership with, but without appreciable direction from Program Group Leader.
- For molecules that are at the Life Cycle Investment Point stage, the Sr CPL partners with the PDG Clinical Operations colleagues to contribute to strategic input, alignment and successful transition of the molecule to Late Stage Development.
- Creates an environment supportive of innovation and smart risk-taking to drive and implement novel approaches to drug development
Functional Management Responsibilities:
Develop future leaders and contribute to building a best-in-class Clinical Operations organization by providing functional and people management in a fast-paced, ever-evolving matrix organization. The Sr CPL:
- Provides program leadership to the gRED Clinical Operations study teams with program specific guidance, clinical trial management expertise, operational strategies, and direction to achieve results.
- Mentors and coaches staff (direct and dotted-line reports). Provides timely feedback to functional managers regarding staffing needs and individual performance in the program.
- Provides coaching, mentoring, performance and talent management, and succession planning. Identifies, recruits, hires, and develops Clinical Operations staff, as well as oversees their work to ensure all department goals, deliverables, and objectives are met.
- Ensures that employees are appropriately trained and comply with company and regulatory standards
- Creates a positive work environment by encouraging mutual respect, innovation and accountability. Creates and maintains Clinical Operations as a ‘great place to work’
- Resources projects to enable teams to meet deliverables
- Actively participates and contributes to governance (eg, gPRC, DRC) and CPL leadership forums.
- Sponsors, leads and/or participates in critical department or broad organizational, cross-functional initiatives.
- Fosters a continuous improvement mindset by partnering to optimize processes; to create and maintain role definitions and standards; and to develop role-based competency and training programs.
- Serves as Business Process Owner and oversees Subject Matter Experts as nominated
- Leads and supports staff through organizational change and growth and provides input to senior management on potential organizational changes and improvements.
- Creates an environment supporting innovation and smart risk to help the department continuously evolve, improve and excel.
Who You Are
Qualification requirements include:
- Bachelor’s degree, preferably in a scientific or healthcare discipline, or minimum 12 years combined relevant education and work experience; advanced degree preferred.
- 10+ years of experience in clinical and drug development, including 5+ years of clinical trial management experience.
- 2+ years experience in clinical program management or a directly related role.
- Functional management experience preferred.
- Experience in early phase clinical development.
- Working knowledge of international regulatory and ICH GCP guidelines.
- Demonstrated understanding, knowledge, and experience of drug development in a complex setting with particular focus on early development.
- Extensive experience in pharmaceutical industry and drug development experience. Therapeutic area experience in various indications a plus, with particular focus on early development in a complex setting. Experience in other business areas provides added value.
- Thorough understanding of all aspects of clinical drug development, proven experience in strategic planning, proven ability to understand and critically assess the global clinical development plans, protocol design, resources needs, global budgets and timelines for programs.
- Demonstrated exceptional leadership, interpersonal skills, influencing, communication and strategic project management skills at all levels of an organization. Communicates with energy and passion, to engage and inspire others.
- Demonstrated ability to understand and execute clinical development strategies and mobilize stakeholders. Ability to anticipate and solve complex problems that have impact in multiple areas.
- Demonstrated ability to think strategically and drive development of program strategies with strong decision making and ability to weigh short and long term impact of decisions
- Significant experience in leading teams in a matrix environment, including motivation and delegation.
- Ability to maintain relevant knowledge of business, regulatory and therapeutic advances that may impact planning or ongoing operational strategies and translate knowledge into influencing strategic direction. Tracks emerging trends and applies these to improve business outcomes.
- Ability to think beyond the Clinical Operations function, identifying connections between different areas of the organization to see the business in a new way
- Recognized as expert in therapeutic area and/or recognized as leader across organization
- Strong analytical skills, including previous experience with forecasting and analyzing benchmarking research results. Ability to analyze complex activities and information to arrive at logical conclusions, and that meets the overall objectives and long-range plans of an organization.
- Strong financial acumen with experience managing clinical program budgets
- Effective communication skills; fluency in verbal and written English, any other language skills may be an asset
- High level of initiative, ability to work independently with appropriate consultation as needed.
- Demonstrated experience in various therapeutic areas
- Strong analytical and strategic agility skills
- Excellent planning and organizational skills
- High level of initiative and ability to work independently
- Exceptional leadership skills, including motivation and delegation
- Highly effective team player and exceptional interpersonal skills
- Proven ability to provide performance management coaching and staff development
- Proven ability to implement and manage a clinical program (i.e. a series of studies compromising a clinical development plan)
- Ability to drive, encourage and support innovation. Demonstrated ability to challenge established practices and concepts.
- Highly effective verbal and written communication skills in English
- Willingness to travel domestically and internationally, and work across cultures.
A Job with Benefits Beyond the Benefits
People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen.
No matter who you are or what role you play, you’ll help change the face of medicine and make a real difference in the lives of people facing the most challenging medical conditions. Plus, you’ll thrive in our one-of-a-kind culture, where diversity is celebrated, employees are valued for their contributions and we all serve as advocates for change who continually find ways to do things better.
The next step is yours. To apply today, click on the "Apply" button below.
Genentech, a member of the Roche Group, has multiple medicines on the market for cancer and other serious illnesses.
Genentech is an Equal Opportunity Employer: Minorities/Women/Disability/Veteran
Apply Link: http://www.gene.com/careers/find-a-job/apply/2551649203?src=JB-11480