Sr Director, Clinical Research Pulmonary Medicine

Employer
Gilead Sciences
Location
Capitol Hill, WA
Posted
Sep 13, 2021
Closes
Sep 17, 2021
Ref
2351864461
Organization Type
Corporate
Job Description
Specific Responsibilities:

The clinical research physician will play a key role at all stages of clinical development for product programs from the drug discovery stage through product registrations world-wide.
The successful candidate will have primary oversight for ongoing and planned product trials within the inflammation therapeutic area, specific to diseases /targets related to an emerging fibrosing interstitial lung disease program (eg, IPF/PF-ILD). The candidate may also provide expert support to our respiratory virus programs
The Clinical Research MD will report to a senior member of the inflammation clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities.
Essential Duties and Job Functions:

Will integrate with a team providing matrix leadership that ensures execution of innovative, highly proficient and feasible strategies for drug development specific to a growing internal portfolio of therapeutics targeting fibrosing ILDs
Will be part of a team responsible for all scientific aspects of conceptualizing and planning trials.
Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.
Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
Coordinates the collection and analysis of clinical data for internal analysis and review.
Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections.
Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.
Develops manuscripts for publication in peer-reviewed journals.
Will be part of a team responsible for defending the clinical development program before regulatory authorities.
Serves as a scientific and clinical resource within Gilead Clinical Research
Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff.
Assists in the clinical evaluation of business development opportunities.
Knowledge, Experience and Skills:

MD, DO or equivalent.
Three (3)+ years' experience required in pharmaceutical industry with a proven success record in clinical research studies, trial design, execution and oversight.
Experience in the design of study protocols, consent forms, case report forms, database design, data analysis and the construction of appropriate tables and figures
Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices; direct experience in the study recruitment and consent is highly desirable.
Direct experience in the strategic, and tactical implementation of drug development
Experience in inflammation/rheumatology/autoimmunity drug development.
Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
Strong leadership skills within a highly matrixed environment with an ability to set vision, lead change, and mentor others.
Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
Excellent scientific written and oral communication skills.
Ability to partner, influence and inspire others.
Experienced with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.
Desired skills:

Training in pulmonary medicine preferred
Familiarity with fibrosing interstitial lung diseases preferred
Clinical or clinically-oriented translational research experience preferred
Pharmaceutical/biotech industry experience in clinical development preferred
Successful leadership and management experience
Excellent organizational and communication skills are critical
Experienced with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
Well developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.