Senior Medical Director, Clinical Development

About the role

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.

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 continue to be integrated into and drive DynamiCure’s oncology development strategies
• Translate oncology development program strategies into clinical study concepts that can be executed without compromising the scientific rigor of the study
• Adeptly execute 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
• Assist in driving the timely execution of multiple assets and studies within the oncology portfolio
• Act 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
• Organize and present at relevant clinical advisory boards, DMC’s and medical/scientific meetings
• Develop and maintain relationships and serve as medical liaison with key opinion leaders and PIs
• Lead cross-functional teams
• Mentor more junior members of the clinical development team
• Present DynamiCure programs to external parties and contribute as needed to business development efforts

Required Education, Experience, Skills, And Competencies

• M.D. or D.O. degree and clinical oncology experience required & at least 5 years’ experience working in the biotech and/or pharmaceutical industry; board certification/eligibility in oncology and MD/PhD are strongly preferred
• Hands-on oncology or I/O drug development experience within industry oncology in pharmaceutical and/or biotech company setting either for small molecules or large molecules
• Proven clinical development strategist with hands-on experience with designing, implementing, and conducting clinical trials
• Knowledge of carrying out oncology clinical trials, including knowledge of current treatment landscapes
• Strategic leadership and tactical skills, excellent initiative, and judgment, and demonstrated ability to positively represent the goals of DynamiCure
• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
• Proven track record of strong collaboration skills and the ability to partner with others to implement innovative oncology development strategies
• Ability to communicate and work independently with scientific/technical personnel with excellent oral presentation skills
• Think critically and demonstrate troubleshooting and problem-solving skills
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities