Vaga de Director, Clinical Development Oncology – LATAM region
1 vaga: | Publicada em 09/03
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At Gilead, were creating a healthier world for all people. For more than 35
years, weve 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
worlds biggest health challenges, and our mission requires collaboration,
determination and a relentless drive to make a difference.
Every member of Gileads 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 were 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 todays 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 project direction and status to varying organizational
levels, including leadership teams, executives and steering committees.
When needed, ability to travel.
Gilead Core Values
Integrity (Doing Whats Right)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
Inclusion (Encouraging Diversity)
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.