Associate Director, Clinical Site Partner, Clinical Operations at GILEAD REMNANT PTE LTD

Johannesburg, Gauteng, South Africa -

Full Time

Start Date

Immediate

Expiry Date

13 May, 26

Salary

0.0

Posted On

12 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations, Communication, Leadership, Negotiation, Conflict Resolution, Strategic Agility, Critical Thinking, Organizational Skills, Interpersonal Skills, Team Dynamics, Self-Management, Problem Solving, Site Management, Regulatory Knowledge, Performance Metrics, Therapeutic Expertise

Industry

Biotechnology Research

Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description We are looking for a highly motivated Associate Director, Clinical Site Partner, Clinical Operations, based at our South Africa affiliate in Johannesburg. 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 Gilead’s preferred network of sites within your region. Additional local responsibilities may be required as needed/appropriate for the local geography. Your role 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. Identify investigator sites 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 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 study start-up to close-out 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. Gather constructive feedback and insights from clinical sites to share with Gilead internal stakeholders around clinical studies or programs for improvements. 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. Your profile We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. Education & Experience 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 (Oncology experience is a bonus). Strong working knowledge of Good Clinical Practice and in country regulatory guidelines and requirements. Knowledge & Skills Strong self-management and organizational skills; ability to manage workload, set priorities and adjust as needed. Ability to work both independently and collaboratively. Established relationships and experience in both the community and academic site and network setting. 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. Extensive travel required. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Responsibilities

The Associate Director will establish and maintain relationships with investigator sites to optimize clinical trial delivery and serve as a communication bridge between sites and Gilead. Responsibilities include site identification, enrollment planning, and resolving issues to ensure timely trial execution.