Senior Medical Director
About The Position
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
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
