Assoc Director, Clinical Operations, Clinical Site Partner (Inflammation)

Gilead Sciences

1d•$177,905 - $230,230•Hybrid

About The Position

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products. You will be responsible for establishing and maintaining relationships with active and potential investigator sites to optimize delivery of clinical trial programs for an assigned therapeutic area, inclusive of site identification and qualification, enrollment planning and execution, timely delivery of database lock and study close out. You will also serve as an effective communication bridge between investigator sites and the Gilead Development organization and a point of escalation for both Gilead and investigator site staff, including partnering with Gilead and investigator site staff to resolve issues and remove barriers as needed. You will also be responsible for establishing and managing relationships with regional / local patient advocacy groups (PAGs) and communities ensuring incorporation of the patient perspective and voice across the continuum of product development. Additional local responsibilities may be required as needed/appropriate for the local geography.

Requirements

BA / BS / RN with 10 or more years’ relevant clinical or related experience in life sciences. Or, MA / MS / PharmD / PhD with 8 or more years’ relevant clinical or related experience in life sciences.
Combination of scientific/medical expertise in a relevant therapeutic area, including knowledge 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.

Nice To Haves

Prior inflammation clinical trials/operations experience in company sponsored clinical trials strongly preferred
Strong self-management and organizational skills; ability to manage workload, set priorities and adjust as needed.
Ability to work both independently and collaboratively.
Excellent verbal and written communication and oral presentation skills (both in English and local language).
Ability to establish and maintain strong long-term relationships with internal and external key stakeholders.
Strong interpersonal skills and understanding of team dynamics.
Strong leadership presence with demonstrated ability to lead without authority at all levels of internal and external stakeholders.
Strong negotiation and conflict resolution skills.
Demonstrated strategic agility and broad business acumen.
Possess a combination of critical thinking and operational expertise and efficiency.
Self-motivated with proactive issue monitoring and seeks opportunities to remove barriers.

Responsibilities

Establish and maintain strong professional and collaborative relationships with investigator sites by leveraging disease area expertise to optimize delivery of clinical trial programs.
Develop strategies to drive concierge level support for preferred sites to ensure Gilead becomes the Sponsor of Choice.
Track key performance metrics to assess site performance and identify opportunities for acceleration and continuous improvement.
Establish and manage strong working partnerships with local PAGs and communities, including liaising with patient groups in relation to protocol development and study design considerations.
Serve as an internal resource to champion and promote an environment that incorporates the patient perspective and voice across the continuum of product development based on patient insights obtained from local PAGs and communities.
Identify investigator sites, PAGs and communities in alignment with portfolio strategy and priority to expand Gilead’s clinical research partnership network.
Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel.
Share ongoing information with investigators, PAGs and communities regarding Gilead's development pipeline and collect and report field-based intelligence in relation to competitive landscape, patient treatment pathways and other operational considerations that may impact Gilead's clinical trial program.
Provide support to study teams and Clinical Research Organizations (CROs) to ensure timely delivery of clinical trials from initiation to closeout such as during feasibility, site recommendations, attendance at initiation visits, facilitation of communication and ongoing support of trial enrollment by engaging with site staff to identify enrollment barriers and working with study teams to find solutions.
Support the development and implementation of applicable site risk plans to ensure achievement of key study and site level milestones such as first patient first visit, delivery of clinical trial enrollment commitments and database lock.
Serve as a local point of escalation for investigator sites and partner with the appropriate parties to resolve issues and remove barriers to clinical trial execution at a site and/or country level.
Proactively communicate and escalate issues identified at investigator sites and partner with internal functional areas to develop corresponding mitigation strategies and recommended approaches, including participation in development and implementation of solutions to address issues.
Leverage and present metrics to inform site / country / regional level decision making.
Develop local knowledge of investigator site capabilities and past performance and provide input into site-level recruitment forecasts, recruitment methodologies, monitor performance and take appropriate action to maintain timelines.
Partner closely with internal Clinical Operations, Clinical Development and Medical Affairs to ensure effective communication and unified messaging to investigator sites, PAGs and communities.