Associate Director, Clinical Operations, Clinical Site Partner – Inflammation

This is a fully remote position, open to applicants in United States.

📋 Description

• Build and sustain robust professional and collaborative relationships with investigator sites by utilizing disease area expertise to enhance the execution of clinical trial programs.

• Formulate strategies to provide concierge-level support for preferred sites, ensuring that Gilead becomes the Sponsor of Choice.

• Monitor key performance indicators to evaluate site performance and pinpoint opportunities for acceleration and ongoing enhancement.

• Create and nurture effective working relationships with local Patient Advisory Groups (PAGs) and communities, including engaging with patient groups regarding protocol development and study design considerations.

• Act as an internal advocate to foster and promote a culture that incorporates the patient perspective and voice throughout the product development continuum, based on insights gathered from local PAGs and communities.

• Identify investigator sites, PAGs, and communities in accordance with portfolio strategy and priorities to broaden Gilead’s clinical research partnership network.

• Maintain therapeutic and technical expertise to facilitate scientific discussions with investigators and site personnel.

• Disseminate ongoing information to investigators, PAGs, and communities regarding Gilead's development pipeline while gathering and reporting field-based intelligence about the competitive landscape, patient treatment pathways, and other operational factors affecting Gilead's clinical trial programs.

• Offer support to study teams and Clinical Research Organizations (CROs) to guarantee timely execution of clinical trials from initiation to closeout, including feasibility assessments, site recommendations, participation in initiation visits, facilitating communication, and providing ongoing support for trial enrollment by working with site staff to identify enrollment barriers and collaborating with study teams to develop solutions.

• Assist in the development and implementation of relevant site risk plans to ensure the achievement of key study and site-level milestones, such as first patient first visit, meeting clinical trial enrollment commitments, and database lock.

• Serve as a local escalation point for investigator sites and collaborate with the relevant parties to resolve issues and eliminate obstacles to clinical trial execution at both site and country levels.

• Proactively communicate and escalate issues encountered at investigator sites while partnering with internal functional areas to devise corresponding mitigation strategies and recommended actions, which may include participating in the development and implementation of solutions to address these issues.

• Utilize and present metrics to guide decision-making at the site, country, and regional levels.

• Develop local insights into investigator site capabilities and past performance, contributing to site-level recruitment forecasts and methodologies, monitoring performance, and taking necessary actions to meet timelines.

• Collaborate closely with internal Clinical Operations, Clinical Development, and Medical Affairs to ensure effective communication and consistent messaging to investigator sites, PAGs, and communities.

⛳️ Requirements

• BA / BS / RN with 10 or more years of relevant clinical or related experience in life sciences.

• Or, MA / MS / PharmD / PhD with 8 or more years of relevant clinical or related experience in life sciences.

• A blend of scientific/medical knowledge in a pertinent therapeutic area, including an understanding of the clinical research landscape, and advanced knowledge of Clinical Operations.

• Strong working knowledge of Good Clinical Practice and in-country regulatory guidelines and requirements.

• Previous experience in inflammation clinical trials/operations within company-sponsored clinical trials is strongly preferred.

• Excellent self-management and organizational skills; adept at managing workload, prioritizing tasks, and adapting as required.

• Ability to work independently as well as collaboratively.

• Exceptional verbal and written communication skills, along with strong oral presentation abilities (in both English and the local language).

• Capacity to establish and maintain strong, long-term relationships with key stakeholders, both internal and external.

• Strong interpersonal skills and a good understanding of team dynamics.

• Commanding leadership presence with a proven ability to lead without authority at all levels of internal and external stakeholders.

• Excellent negotiation and conflict resolution skills.

• Demonstrated strategic agility and comprehensive business acumen.

• Possess a combination of critical thinking, operational expertise, and efficiency.

• Self-motivated with proactive issue monitoring and an inclination to seek opportunities to eliminate barriers.

🏝️ Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.

• Discretionary annual bonus.

• Discretionary stock-based long-term incentives (eligibility may vary based on role).

• Paid time off.