The Opportunity:

You will bridge the gap between strategy and execution across the entire trial lifecycle-from early development to late-stage delivery-ensuring our clinical assets are executed with maximum speed, efficiency, and clinical quality. In this role you will have the opportunity to:

Strategic Planning & Alignment:

Develops and executes country-level site engagement strategies aligned with internal priorities, making strategic investment decisions regarding Principal Investigators and clinical sites to support the broader portfolio.(DS) Experience with site budget negotiation, tracking clinical grant payments, and forecasting site-level resource needs

Early Feasibility & Study Set-Up:

Conducts early, strategic landscaping and site engagement (in-person or remote) during the protocol concept and study set-up phases to identify optimal sites, evaluate country feasibility, and accelerate recruitment.(DS) Demonstrated ability to drive study start-up metrics, optimize cycle times, and utilize enrollment forecasting tools to ensure site milestones are met on schedule.

Relationship Management & Site Support:

Builds deep, multi-stakeholder relationships at strategic sites (including investigators, pharmacists, and administration), acting as a \"site champion\" and Primary Point of Contact to maintain cross-study consistency and address site needs. Must have and demonstrate exceptional communication skills both oral and written.

Issue Escalation & Performance Oversight:

Serves as the local escalation point for study challenges, monitors investigator performance, supports motivational site visits to boost recruitment, and manages sensitive communications during premature site closures. Be able to manage and navigate sensitive and complex situations under unknown or un-clear circumstances.

Cross-Functional Collaboration & Reporting:

Partners seamlessly with internal teams (e.g., Medical Affairs, Study Start-Up) and CROs to ensure unified site communication, while maintaining meticulous documentation of site visits and interactions in central systems (e.g., Veeva).

Portfolio Oversight & Compliance:

Manages assigned local/global clinical studies by overseeing CRO performance, mitigating timeline or operational risks, ensuring eTMF completeness, and maintaining continuous inspection readiness. (DS)

Digital Clinical Trial:

Focus on driving adoption of DCT and digital solutions with our sites i.e. eConsent, eSource, Remote Data Entry, etc. Actively pursuing and reviewing digital tools with sites to examine challenges and provide solutions.

Who you are:

Degree (MD, PhD, MA / MS, BA / BS) in life sciences or equivalent. Minimum 5+ years of relevant clinical research or clinical operations experience in pharmaceutical, biotech or related industry; Sponsor experience preferred. Experience in end-to-end product development and expert understanding of ICH/GCP are both essential. Understanding of end-to-end clinical trial processes, including monitoring, and strong knowledge of clinical trial regulations and guidelines. Proven track record in managing site relationships and overseeing complex clinical trials. Exceptional interpersonal, cross-functional, negotiation, and influencing skills with a proven track record of building high-trust, sustainable relationships with internal stakeholders, CROs, and site personnel. Ability and willingness to travel domestically between 30-50% dependent on business or site needs.

Preferred qualifications:

Postgraduate degree or master's degree will be valued but not required Prior experience working directly with local trial sites and a strong existing network within the regional healthcare ecosystem is a strong plus Highly experienced in early and late phase oncology Highly experienced across multiple disciplines/TAs in non-oncology This role is regional. Applicants should reside within 30 miles of a major airport and should reside within 50 miles of the Primary Location. Preference will be given to applicants who reside within those parameters. Relocation benefits are not available for this posting The expected salary range for this position based on the primary location of Nashville, TN is $108,800 to $202,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #PDG #CREL Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. 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Clinical Research Engagement Lead - South Region (Nashville, TN)