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Sr. Global Clinical Trial Leader

Company: Hoffmann-La Roche Ltd
Location: South San Francisco
Posted on: June 12, 2021

Job Description:

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 development plan.

  • 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 throughout study

  • Champions and demonstrates a patient and site-centric mindset including development and management of study-specific patient recruitment strategies

  • Achieves study milestones and objectives within approved timelines.

  • Owns and manages overall study budget(s), ensuring efficient expenditure and minimizing variance between actual and forecasted spend.

  • 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 strategies.

  • 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 relationships.

  • 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 Operations team.

  • 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 drug development.

  • Highly experienced in simultaneously managing multiple early development phases (I and II), global, complex, and potentially registrational clinical studies and experienced in clinical development.

  • 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 independently.

  • 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 customer.

  • 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 discipline preferred)

  • 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

#LI-CA1

Keywords: Hoffmann-La Roche Ltd, South San Francisco , Sr. Global Clinical Trial Leader, Other , South San Francisco, California

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