Senior Medical Director

Salary :

$266,500 - 319,000 yearly

Company : Bridge Bio Oncology Therapeutics

Job Type : Full Time

San Francisco, United States

Job Description - Senior Medical Director

Full-time

Description

Serve as trial medical lead/medical monitor of assigned clinical studies, including contributing to site selection, study oversight and management plans, CRF design, ICF, enrollment, medical data review, CSR writing, and authoring of clinical modules and clinical review of other modules
Be a leader within and actively participate and contribute to the cross-functional and project teams meetings, including functioning as clinical representative
Cultivate relationships with clinical investigators, clinical consultants, and thought leaders for the execution of ongoing trials and developing opportunities
Serve as trial medical lead/medical monitor of assigned clinical studies, including contributing to site selection, study oversight and management plans, CRF design, ICF, enrollment, medical data review, CSR writing, and authoring of clinical modules and clinical review of other modules
Be a leader within and actively participate and contribute to the cross-functional and project teams meetings, including functioning as clinical representative
Cultivate relationships with clinical investigators, clinical consultants, and thought leaders for the execution of ongoing trials and developing opportunities
Help ensure Clinical Study Team compliance with ethical and GCP guidelines, and FDA, EMEA, ICH, and other regulatory requirements relevant to industry/country/region
Provide expert support for the preparation of clinical/study protocols and amendments, clinical trial documents
Responsible for the clinical sections of regulatory documents (investigator brochures, development safety update report, etc), clinical study reports
Conduct investigator meetings and lead site initiation visits with clinical trial investigators
Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
Translate findings from research and nonclinical studies into clinical development opportunities
Contribute to the clinical portions of writing and preparation of abstracts, presentations, and manuscripts
Attend key scientific congresses and meetings as requested in support of speakers and key opinion leaders
Remain current in relevant therapeutic areas and conversant with the literature as well as critical emerging data
Represent the Clinical Development team during interactions with regulatory agencies, as applicable

Requirements

Trained MD and/or MD-Ph.D. degree
7+ years of experience in drug development, either within the industry or as a clinical investigator/physician-scientist in academia, or equivalent experience; oncology experience is preferred
Patient-focused, with a deep commitment to understanding needs and improving the lives of patients, and a passion for developing novel therapeutics
Demonstrated ability to collaborate successfully with multiple functions in a team environment
Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail
Motivated to work in a fast-paced, high accountability, small company environment; a "can do" and collegial professional who leads through influence and interpersonal skills
Intellectually curious with the courage to challenge and seek new ways to improve work
Strong written and oral communication skills, including presentation skills
Ability to analyze and interpret data and develop written reports and presentations of those data
Solid critical, strategic, and analytical thinking skills
Experience in all aspects of study and protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reporting
Experience in working closely with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical trials

Salary Description

$266,500 - $319,000

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Senior Medical Director

Job Description - Senior Medical Director

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