[Hiring] Associate Director, Clinical Site Partner, Clinical Operations, Oncology @Gilead Sciences
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Role Description
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations play 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.
The Associate Director, Clinical Site Partner, Oncology 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.
Geography - South East / Mid Atlantic
EXAMPLE 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.
• 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.
• 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.
• 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.
• 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.
Qualifications
• Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD/ PharmD and Five Years' Experience
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 (Oncology experience is a bonus).
• Strong working knowledge of Good Clinical Practice and in country regulatory guidelines and requirements.
• 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.
Benefits
• Discretionary annual bonus
• Discretionary stock-based long-term incentives (eligibility may vary based on role)
• Paid time off
• Company-sponsored medical, dental, vision, and life insurance plans
People Leader Accountabilities
• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account.
Apply Now
Apply Now
Role Description
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations play 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.
The Associate Director, Clinical Site Partner, Oncology 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.
Geography - South East / Mid Atlantic
EXAMPLE 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.
• 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.
• 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.
• 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.
• 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.
Qualifications
• Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD/ PharmD and Five Years' Experience
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 (Oncology experience is a bonus).
• Strong working knowledge of Good Clinical Practice and in country regulatory guidelines and requirements.
• 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.
Benefits
• Discretionary annual bonus
• Discretionary stock-based long-term incentives (eligibility may vary based on role)
• Paid time off
• Company-sponsored medical, dental, vision, and life insurance plans
People Leader Accountabilities
• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account.
Apply Now
Apply Now