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Global Sr. Clinical Trial Leader

South San Francisco
California, United States of America

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The Position

Considering local candidates only

The Global Sr. Clinical Trial Leader leads one or more global, cross-functional Protocol Execution Teams (PETs). These complex programs focus on the rapid development of NMEs with limited clinical data, and as such, require implementation of novel and highly flexible, global operational strategies to support exploratory hypotheses, including biomarkers and diagnostics. The Global Sr. Clinical Trial Leader is accountable for ensuring the efficient delivery of global clinical studies.

The Global Sr. Clinical Trial Leader is a proven leader who implements the clinical development plan. A Global Sr. Clinical Trial Leader collaborates expertly and encourages innovative thinking amongst peers and study team members.

Role & Key Responsibilities:

Key roles and responsibilities include, but are not limited to the following:

  • Independently leads one or more complex global cross-functional Protocol Execution Team(s) (PETs) through all study stages (start-up, conduct, close-out) to accomplish studies outlined by the clinical development plan:
  • Maintains high performing teams.
  • Oversees cross-functional activities and ensures delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central / specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker / sample management plans, TMF, and CSRs. Liaises with cross-functional team members including the PET members to solicit input.
  • Provides guidance, approves and implements study plans including; vendor oversight, risk, quality, safety, communication, trial/medical monitoring, TMF.
  • Ensures TMF creation and QC completion.
  • Oversees EDC and CTMS systems and data maintenance.
  • Achieves study objectives and milestones within approved timelines, budgets, and resources, under the direction of the Senior Clinical Program Leader (Sr. CPL).

  • Partners closely with Clinical Science to design and co-author global clinical trial protocols and provides strategic, global operational input on protocol feasibility. Actively contributes to Early Development Team meetings as needed (e.g. Core Team, Development, Clinical, Pharmacology and Biomarker Sub-Teams).

  • Partners with other Roche global units such as late-stage Pharma Development (PD), Medical Affairs (MA), Regional Strategy Leads (RSLs), and Disease Area Strategy teams (DAS), to more effectively build a global operational strategy.

  • Ensures therapeutic area operational expertise by attending scientific presentations and participating in scientific working group meetings with clinical Key Opinion Leaders (KOLs).

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

First-in-Human, Phase Ib, and other signal-seeking Phase I trials, and evidence of activity,

proof-of-concept, dose-ranging, dual New Molecular Entity (NME), and other types of Phase II trials).

  • Leads identification and selection of vendors (participating in the Request for Proposal (RFP) process), on a global scale, in collaboration with Sr. CPL.

  • Utilizes outputs from operational analytical tools to enhance and improve study execution.

  • Provides direction and oversight of outsourced activities to ensure CRO and vendor delivery against

    contracted scope of work

  • Selects and manages global study sites:

  • Conducts global protocol, country and site feasibility assessments; partnering with Sr. CPL on final country and site selection.
  • Oversees all activities related to global site selection, contracting, set-up and maintenance.Partners with Site Contracts on development and finalization of site budget template and budget negotiations.
  • Oversees the development and actively manages study-specific patient recruitment strategies

    through leadership of enrollment planning workshops.

  • Proactively identifies risks and develops risk mitigation strategies to ensure operational effectiveness.

  • Contributes to the efforts and overall success of the wider gRED Clinical Operations team:

  • Provides study-specific training, and operational coaching/mentoring to Clinical Operations staff through delegation and oversight of study activities and deliverables.
  • Collaborates effectively and participates in the CTL Forum and other departmental meetings.Uses extensive experience to contribute to peers’ risk identification and mitigation.
  • Drives identification and synthesis of best practices and process improvements and
  • consistently shares outputs with the broader team.
  • Serves as subject matter expert for mandatory business initiatives and/or functional initiatives.
  • Oversees planning and execution of effective investigator meetings. Accountable for driving the agenda and content for investigator meetings.

  • Fosters investigator and KOL relationships.

  • Stays current on clinical research best practices.

  • Oversees the accuracy and timeliness of CTMS, timeline planning tools and other core systems.

  • Ensures study adherence to ICH/GCP and SOPs.

Key Capabilities

  • The capabilities required for this role are for a proven leader which means the candidate demonstrates the ability to lead cross-functional teams, is self-aware and takes initiative to fix and learn from mistakes, and exercises good judgment and professionalism when leading teams.

  • Highly experienced in simultaneously managing multiple early development phase (I and II), global, complex, clinical studies and generally experienced in clinical research/development.

  • Highly effective verbal (including oral presentations) and written communication skills in English;

    adjusts content and style for audience; effectively delivers key messages; able to manage and communicate with teams and stakeholders.

  • Distills information from multiple sources to create meaningful insights and induces collaboration and innovative thinking across gRED.

  • Demonstrated experience in several therapeutic areas.

  • Proven experience with effective vendor management.

  • Demonstrates strategic thinking skills; manages risks (including risk identification and mitigation);

    identifies critical path / critical dependencies.

  • Strong customer focus with investigators, functional peers, vendors, country affiliates, etc.

  • Establishes own work priorities and timelines; excellent planning and organizational skills.

  • Mentors Clinical Trial Leaders (CTLs) and promotes an environment that fosters trusting and collaborative relationships that encourages innovation, knowledge-sharing and adaptation to change.

  • Effectively and frequently influences and negotiates with key stakeholders to achieve team goals.

  • Flexible, able to successfully navigate self and team through ambiguity, proactive and solution-focused. Consistently supports change in an effort to continue to develop gRED’s dynamic organization.

  • Demonstrates creativity and innovation to support projects and initiatives.

  • Strong technical and analytical skills and ability to manage system data maintenance across multiple

    systems. Ability to interpret outputs from analytical tools to enhance and improve study execution.

  • Self-motivated, achievement-driven and has the ability to work independently.

Education / Qualification:

  • Bachelor’s degree or equivalent required (scientific or healthcare discipline preferred).

  • Mastery of clinical study management, including 3+ years leading cross-functional teams.

  • Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the drug development process.

Other (e.g. Travel):

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

  • Visual acuity and sufficient dexterity to constantly operate a computer and other office productivity machinery (i.e., a calculator, copy machine, and computer printer).

  • Work on nights or weekends is not typically required, however, interaction on global clinical studies requires flexibility for occasional teleconferences / meetings outside of core working hours.

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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