Senior Medical Director, Clinical Development
Senior Medical Director, Clinical Development
DynamiCure Biotechnology
Waltham, MA
See who DynamiCure Biotechnology has hired for this role
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
- 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 currenttreatment 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
Around the Office:
- Flexible scheduling around core hours
- Casual dress code
- Unlimited drinks & snacks
- 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 Referral Program
- Employee Assistance Program
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Health Care Provider -
Industries
Internet Publishing
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