Associate Medical Director, Clinical Development
REMOTE, IL 00000 US
*Depending on experience
•With appropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and study staff.
•Has responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety coding and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
•Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
•May serve on a Clinical Strategy Team as the clinical representative for the protocols for which the incumbent has responsibility. Contributes to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members.
•Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies.
•Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
•Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions.
•Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
•Medical Doctor (M.D), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
•Ability to run a clinical research study with appropriate supervision.
•Strong desire to collaborate in a cross-functional setting.
Strong experience in the site activation. KOL engagement, and providing training for sites.
•Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
•Clinical trial experience in the hematologic malignancies is preferred.
•Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.
•Ability to interact externally and internally to support global scientific and business strategy.
•Must possess excellent oral and written English communication skills.
*CO/NYC candidates might not be considered
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