Director, Clinical Development Oncology
hace 5 días
For Current Gilead Employees and Contractors:
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. Join Gilead and help create possible, together.
**Job Description**:
For over 30 years, Gilead has been a leading innovator in the field of virology, having developed many of today’s leading medicines for treating and preventing HIV and viral hepatitis. More recently, Gilead has expanded its oncology portfolio, and seeks to become a leader in this critical disease area.
In this role as Director, Clinical Development, you will lead regional components of clinical trial programs in Oncology clinical development. For the assigned projects, you are accountable for various aspects of regional ongoing clinical trial program-related activities. These activities include, but are not limited to, medical monitoring and oversight of medical monitors, study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations. You will also closely interact with global development teams to provide strategic input into study designs and clinical development plans.
Reporting to the Head of the International Development Team you will be based in one of the LATAM regional countries with the ability to travel broadly within the region
POSITION OVERVIEW:
- Provides input into or leads the regional 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 regional 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 medical 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 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.- Manages Gilead medical monitors in the region and serves as point of contact for CRO medical monitors in the region- Works closely with clinical operations and Medical affairs in establishing and developing excellent relationships with sites and KOLs in the region
**REQUIREMENTS**:
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.
Minimum Education & Experience- Essential - PharmD, PhD or MSC degree in clinical research or clinical pharmacology with significant drug development experience in the biopharma industry, is required.- MD with board certification in Oncology is highly desirable, including familiarity with clinical oncology medicine- Significant experience working on, with and leading cross-functional project/program teams in biopharma- 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.- Fluency in English and either Spanish or Portugese is essential
Knowledge & Other Requirements- Proven analytical abilities as demonstrated through past experience and/or academic research.- Has core expertise in the assigned or related disease area (oncology), 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 proje
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