Senior Medical Director, Clinical Development at DynamiCure Biotechnology

Waltham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Mar, 26

Salary

0.0

Posted On

04 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Oncology Drug Development, Clinical Development, Regulatory Strategies, Clinical Trials, Collaboration Skills, Scientific Rigor, Problem-Solving Skills, Leadership, Mentoring, Communication Skills, Data Analysis, Relationship Building, Strategic Leadership, Initiative, Judgment, Presentation Skills

Industry

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 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. Ability to think critically and demonstrated 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. Why Work for DynamiCure Around the Office: Flexible scheduling around core hours Casual dress code Unlimited drinks & snacks Benefits: 20 days Paid Time Off 10 paid holidays plus Winter Break Paid Family Leave Full benefits package including: Medical Dental Vision HSA Account with Company contribution 401(K) with up to 5% match Company paid life and AD&D insurance Supplemental life & AD&D insurance Company paid short- and long-term disability insurance Employee Assistance Program Employee Programs: Employee Referral Program Employee Assistance Program 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.

Responsibilities

The Senior Medical Director will provide oncology drug development expertise and ensure scientific rigor in DynamiCure's oncology strategies. They will also serve as a medical monitor and liaise with key opinion leaders and collaborators.