Job Posting Title:Associate Director Clinical Research, GI/Hepatologist Requisition Number: 6831
Country: US
State: California
Job Location: Foster City
Functional Area: CLINICAL
Position Type: Regular
Shift: Days
Specific Responsibilities:
This position will play a key role at all stages of development for all liver disease programs from the drug discovery stage through product registrations world-wide. Responsible for various aspects and oversight for ongoing clinical trials within LDTA. This activity includes but is not limited to abstract submission, investigator meetings and Scientific Advisory Boards. The Clinical Research MD will report to a senior member of the LDTA clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities.
Essential Duties and Job Functions:
Responsible for all scientific aspects of conceptualizing and planning trials.
Recognized across the R&D function as a key resource within Clinical Research.
May serve as a resource to other functions in evaluating business development opportunities.
Excellent scientific communication skills (both verbal and technical) and interpersonal skills are required.
This position reports to the head of a therapeutic area.
Provides high level and complex scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines.
Primary responsibilities include providing high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as 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.
Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
Also manages the clinical research component in the preparation/review of regulatory documents, IND annual reports, IND safety reports, 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.
Leads two or more specific components of cross-functional strategic initiatives.
Essential Duties and Job Functions:
Essential functions include: provide leadership and medical expertise to the Clinical Department and all of the Liver Disease Therapeutics Division; review and design protocols; evaluate safety and efficacy data; analyze and summarize data for presentation to senior management and regulatory agencies; provide assistance and Support in managing relationships with regulatory affairs, biometrics and other non-clinical departments within Gilead; provide strategic guidance on non-regulatory clinical trial plans.
Knowledge, Experience and Skills:
•The successful candidate will have the knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of clinical research.
•Excellent scientific written and oral communication skills are required.
Must possess a proven ability to work highly effectively with multiple departments.
•Must be capable of working with attention to detail in a time sensitive environment.
•3+ years of relevant experience in clinical research with an MD and a GI/Hepatology specialization.
•Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is preferred.
•The candidate we seek is expected to have a professional relationship with therapeutic area opinion leaders worldwide, and is equally comfortable discussing the science and research approaches that are critical for study protocol design, clinical endpoints and data interpretation.
•Innate flexibility to work in a rapidly growing matrixed environment. Strong leadership skills with an ability to set a vision, lead change, and mentor others. Strategic thinker with ability to formulate, develop and execute clinical strategies. Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
