Gilead Sciences, Inc.
Director, Clinical Development
Gilead Sciences, Inc., Foster City, California, United States, 94420
Director, Clinical Development
United States - California - Foster City Clinical Development & Clinical Operations Regular
As the Director, Clinical Development, you will typically lead multiple components of clinical trial programs in Inflammatory Bowel Disease clinical development. For the assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.
Key Responsibilities
Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules / products.
Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines
Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
Provides ongoing clinical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
Coordinates the collection and assimilation of ongoing data for internal analysis and review.
Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
Presents scientific information at scientific conferences as well as clinical study investigator meetings.
Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
Minimum Required Education and Years of Experience Bachelor's Degree and Twelve Years’ Experience
OR
Masters' Degree and Ten Years’ Experience
OR
PhD and Eight Years’ Experience
Preferred Education & Experience
PharmD or PhD in clinical research or clinical pharmacology with 8+ years’ scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
MS with 10+ years’ relevant scientific and/or drug development experience.
BS or RN with 12+ years’ relevant scientific and/or drug development experience.
Relevant experience in IBD or Immunology is preferred.
Experience in the biopharma industry is preferred.
Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
Proven analytical abilities as demonstrated through past experience and/or academic research.
Has core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
When needed, ability to travel.
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. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
Job Requisition ID R0045128
Full Time/Part Time Full-Time
Job Level Director
#J-18808-Ljbffr
As the Director, Clinical Development, you will typically lead multiple components of clinical trial programs in Inflammatory Bowel Disease clinical development. For the assigned projects, you are accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.
Key Responsibilities
Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules / products.
Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines
Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
Provides ongoing clinical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
Coordinates the collection and assimilation of ongoing data for internal analysis and review.
Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
Presents scientific information at scientific conferences as well as clinical study investigator meetings.
Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
Minimum Required Education and Years of Experience Bachelor's Degree and Twelve Years’ Experience
OR
Masters' Degree and Ten Years’ Experience
OR
PhD and Eight Years’ Experience
Preferred Education & Experience
PharmD or PhD in clinical research or clinical pharmacology with 8+ years’ scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
MS with 10+ years’ relevant scientific and/or drug development experience.
BS or RN with 12+ years’ relevant scientific and/or drug development experience.
Relevant experience in IBD or Immunology is preferred.
Experience in the biopharma industry is preferred.
Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
Proven analytical abilities as demonstrated through past experience and/or academic research.
Has core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
When needed, ability to travel.
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. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
Job Requisition ID R0045128
Full Time/Part Time Full-Time
Job Level Director
#J-18808-Ljbffr