Senior Medical Director, Clinical Development

Job Description

Job Description

Senior Medical Director, Clinical Development

DynamiCure is seeking a talented, independent, and motivated clinician to help build our clinical development group.  You will join a small but growing clinical development group contributing to the medical function, including designing, implementing, and communicating global clinical development plans for our vascular normalization and tumor microenvironment programs. You will serve as an internal and external clinical leader, including interactions with key academic advisors, principal investigators, patient groups, regulatory authorities, academic and industry collaborators as well as DynamiCure’s senior management and Board of Directors.

As a key contributor you will be a thought partner with the VP of Clinical Development for innovative oncology development strategies, as well as a collaborator with discovery, preclinical and translational researchers focused on development of novel vascular normalization and TME modulators.

Reports to : VP, Clinical Development

Travel expectations : 20%

Key Responsibilities and Activities

• Provide oncology drug development expertise to an expanding oncology portfolio, all developed and discovered within DynamiCure.
• Provide sound clinical development guidance to key stakeholders across DynamiCure.
• Ensure that scientific rigor and innovation continues to be integrated into and drives DynamiCure’s oncology development strategies.
• Excellent scientific standing among peers and the ability to address issues with a very high level of scientific rigor and creative solutions.
• Adeptly translate oncology development program strategies into clinical study concepts that can be executed without compromising the scientific rigor of the study.
• Assist in driving the timely execution of multiple assets and studies within the oncology portfolio.
• Ensure excellence in both strategy and execution by partnering closely with clinical operations, biostatistics, data management, program management, and research colleagues.
• Work closely with regulatory leaders to support regulatory submissions and develop regulatory strategies.
• Responsible for the clinical content of clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports.
• Serve as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators : CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials.
• Responsible for analysis of clinical data, including safety monitoring in collaboration with PV.
• Develop and maintain relationships and serve as medical liaison with key opinion leaders and PIs.
• Organize and present at relevant clinical advisory boards, DMC’s and medical / scientific meetings.
• Demonstrated capability to lead cross-functional teams.
• Able to provide leadership and mentor more junior members of the clinical development team.
• Able to present DynamiCure programs to external parties and contribute as needed to business development efforts.

Required Education, Experience, Skills, and Competencies

Why Work for DynamiCure

Around the Office :

Benefits :

Medical

Employee Programs :

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law .

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