Sr. Global Clinical Trial Leader
Company: Hoffmann-La Roche Ltd
Location: South San Francisco
Posted on: June 12, 2021
The Genentech Research and Early Development (gRED) Sr. Global
Clinical Trial Leader (Sr. CTL) is a leader who is accountable for
the strategic planning, execution and delivery of one or more early
development global clinical trials. The Sr CTL is experienced at
driving the study strategy, leading cross-functional global teams;
overseas vendors, proactively manages risks and champions and
supports change. These complex programs focus on the rapid
development of new molecular entities with limited or no clinical
data, and as such, require implementation of novel and highly
flexible global operational strategies.
Role & Key Responsibilities:
Independently leads and provides direction over one or more
complex, cross-functional Protocol Execution Team, (PETs) through
all study stages (start-up, conduct, close-out) in order to
maintain the clinical development plan.
Displays leadership by creating a positive work environment by
inspiring and influencing and encouraging mutual respect, instills
innovation and accountability on a functional and project level,
both locally and globally to implement and deliver the clinical
Oversees and drives PET level cross-functional activities and
ensures delivery of critical clinical trial documents such as
vendor specifications, drug supply forecasting, monitoring and
communication plans, biomarker sample management plans, quality of
trial master files and clinical study report.
Partners closely with Clinical Science to provide strategic,
global operational input on protocol design, feasibility and
ability to execute.
Critically reviews and provides operational insights on
protocols and informed consents.
Plays a key role in country and site identification and
selection and provides appropriate and strategic oversight
Champions and demonstrates a patient and site-centric mindset
including development and management of study-specific patient
Achieves study milestones and objectives within approved
Owns and manages overall study budget(s), ensuring efficient
expenditure and minimizing variance between actual and forecasted
Manages operations resources through effective delegation of
responsibilities; identifies resource needs and risks through
proactive long range planning of study needs in partnership and
overall direction with the Program Lead.
Through strategic and critical thinking skills; identifies
risks, and works with the PET team to manage and develop mitigation
Collaborates and partners closely with cross enterprise Roche
global units (e.g. MSLs, country affiliates) for planning and
effective delivery of the trial Provides leadership in therapeutic
area operational expertise and builds investigator
May have the opportunity to actively contribute to Early
Development cross functional strategic planning meetings.
Contributes to the overall success of the wider gRED Clinical
Partners with gRED and pan-roche colleagues to develop process
improvements and establish best practices which enhances the
execution of clinical trials across the organization.
- Provides study-specific training, including onboarding,
mentoring and coaching to Clinical Operations staff through
delegation and oversight of study activities and deliverables and
willingly shares expertise and knowledge with peers.
Experience, Skills, Behaviors, Knowledge:
Recognized as expert thought partner in clinical trial
management with thorough understanding of all aspects of clinical
Highly experienced in simultaneously managing multiple early
development phases (I and II), global, complex, and potentially
registrational clinical studies and experienced in clinical
Ability to drive and lead cross-functional global teams
including key external partners, builds collaborative working
relationships within and external to R/GNE, using the skills of
creativity and influence to find creative solutions.
Demonstrated ability to work in a volatile, uncertain, complex
and ambiguous (VUCA) environment and skilled at making quick and
informed decisions with limited information.
Is self-aware, motivated, achievement-driven and can work
Proven experience with effective clinical trial implementation
and vendor management.
Demonstrates an analytical mindset and is skilled at analyzing
complex information to arrive at reasonable conclusions.
Strong customer focus with investigators, functional peers,
vendors, country affiliates,etc with the patient being the ultimate
Demonstrated ability to think globally beyond their study and
develop creative solutions to problems including welcoming
diversity of thought to make decisions.
Flexible, adaptive and successfully navigates self and team
through ambiguity, is proactive and solution-focused.
Consistently champions and supports change to positively impact
the business and its customers.
- An experienced leader who is curious with a growth mindset and
willingness to continuously learn.
We are seeking applicants for this impactful role who possess
the following qualifications:
Bachelor's degree or equivalent (scientific or healthcare
7+ years clinical and drug development experience; ideally 3+
years clinical trial management experience including leading and
managing cross functional teams
3+ years of experience leading cross-functional teams
Strong skills in coaching, developing and mentoring members of a
high performing team
Experience in several therapeutic areas
Working knowledge of GCP/ICH requirements, international
regulatory guidelines, and the drug development process.
Experience managing complex early development (phase I and II)
global clinical studies
Demonstrated mastery of clinical study management
Strong customer focus with investigators, peers, vendors,
country affiliates, and other contacts with the ability to build
effective relationships across cultures
Strong oral and written communication skills with the ability to
influence and negotiate
Excellent planning and organization skills
Strategic thinking capabilities, strong analytical skills and an
innovative approach to problem solving
Willingness to travel domestically and internationally
- Flexibility for occasional teleconferences / meetings outside
of core working hours
Keywords: Hoffmann-La Roche Ltd, South San Francisco , Sr. Global Clinical Trial Leader, Other , South San Francisco, California
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