Clinical Program Director
Diversity & Inclusion
Company: Genentech
Location: San Francisco
Posted on: February 25, 2021
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Job Description:
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.
Program Management Responsibilities Through appropriate leadership,
direction and operational expertise, leads 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 including
external partners and vendors through oversight, guidance,
strategies and direction to achieve results. 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
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 as a member of
global disease teams in partnership with Product Development,
Pharma Research and Early Development, and Genentech Research and
Early Development.
Functional Management Responsibilities Provides 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. Identifies, recruits, and hires Clinical Operations
Study Management staff, as well as oversees their work to ensure
all department goals, deliverables and objectives are met.
Identifies and manages resource needs through proactive planning
and effective recruitment. Ensures that employees are appropriately
trained, developed and coached to comply with company policies and
Global regulations. Participates in and/or leads working groups
and/or business improvement efforts within the Genentech Research
and Early Development organization to improve clinical trial
processes, systems, methodologies, and tools. Participates in
enterprise wide initiatives (as needed) to support and influence
the future direction of the organization. Partners with Early
Clinical Development Business Operations team to develop role-based
competency and training strategies and programs. Partners with
Early Clinical Development Informatics team to establish strategies
and priorities in support of improving and advancing clinical
trials. Advocates/drives/supports goals and changes within the
organization. Leads 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 Bachelor's Degree or equivalent required (scientific
or healthcare discipline preferred). Advanced degree preferred. 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. Working knowledge
of international regulatory and ICH Good Clinical Practice
guidelines. 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.
Willingness and ability to travel domestically and internationally,
and work across cultures. #ClinicalTrials #ProgramManagement #GCP
#Biotech #SFBayArea Who We Are Genentech, a member of the Roche
group and founder of the biotechnology industry, is dedicated to
pursuing groundbreaking science to discover and develop medicines
for people with serious and life-threatening diseases. To solve the
world's most complex health challenges, we ask bigger questions
that challenge our industry and the boundaries of science to
transform society. Our transformational discoveries include the
first targeted antibody for cancer and the first medicine for
primary progressive multiple sclerosis. Diversity and Inclusion
(D&I) are critical to the success of our company and our impact
on society. We believe that by championing diversity of background,
thought and experience, we can foster a sense of belonging and
provide an environment where every employee feels valued, included,
and able to contribute their best for the patients we serve. We're
focused on attracting, retaining, developing and advancing our
people to their full potential by rewarding bold ways of thinking
and integrating inclusive behaviors into every aspect of our work.
The next step is yours. To apply today, click on the "Apply for
this job" 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 .
Keywords: Genentech, San Francisco , Clinical Program Director
Diversity & Inclusion, Healthcare , San Francisco, California
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