- Lead and demonstrate ownership of early stage (phase 1-2) clinical trial design for novel, first-in-class tri-specific antibodies or cytokine programs for treatment of cancer
- Write clinical trial synopsis and protocols and associated documents
- In collaboration with the clinical operations team, contribute to selection of investigators and oversee project-related education of investigators, study site personnel, and study staff
- Plan and direct all clinical aspects related to specific programs
- Lead clinical study teams, monitor clinical trials (medical monitoring), and review, analyze, interpret, and communicate safety and efficacy data
- Collaborate with pharmacovigilance in safety surveillance and reporting of critical safety data to regulatory authorities
- Prepare clinical reports and publications
- Present at scientific and medical advisory board meetings and at regulatory meetings
- Develop and maintain cross-functional relationships with academic investigators, pharmaceutical partners/sponsors, CROs, KOLs, and patient advocacy groups
- Contribute to company's planned regulatory filings including authoring clinical sections for INDs and other related documents
- Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
- Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards
- Participate in or lead clinical development contributions to due diligence or other business development activity
- As required by program needs, contribute in partnership with Discovery and Translational Medicine colleagues to the design and implementation of translational strategies
- Provide medical guidance to cross-functional team members such as Clinical Operations, Biostatistics, Program Leadership/Management, Clinical Operations, Translational Medicine, Discovery, and others
- MD (hematology/oncology) or MD/PhD (hematology/oncology), with at least 3-5years successful track record in biotech or pharma in Medical Director roles in oncology and cancer immunotherapy (title commensurate with experience)
- Fellowship training and Board certification in adult or pediatric hematology/oncology is preferred
- Significant pharmaceutical drug development experience gained through direct involvement in development of IO drugs to clinical PoC, and preferably to the market, in the US or EU
- Ability to run a complex clinical research program with diverse stakeholders
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
- Preferred candidates have both significant clinical experience and a solid research background in hematology/oncology and immunology/immunotherapy involving cytokines or other immune modulators
- Developed leadership skills such as working well with others, the ability to bring out the best in colleagues on a cross- functional team, and being highly collaborative, team oriented, and decisive after reviewing the requisite scientific evidence
- Excellent communication and presentation skills are essential
- Willingness to travel to clinical sites, congresses, regulatory interactions, and home office as required and necessary in support of the project(s)
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Medical Director
2 weeks ago
Precision Life Sciences Cambridge, United StatesProvide medical expertise and leadership in the design and implementation of clinical development strategies aligned with company objectives. This position will fill an open vacancy while an FTE is hired. · - Lead the development of clinical trial protocols, ensuring scientific r ...
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Medical Director
5 days ago
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Medical Director
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Mass General Brigham Community Physicians Waltham, MA, United States Full timeNewton-Wellesley Medical Group (NWMG), a member of Mass General Brigham Community Physicians, is seeking a Medical Director to oversee our outpatient primary care practice located in Waltham, MA. Candidates must be board certified or board eligible in FM or Med-Peds. · The Role: ...
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Medical Director/Executive Medical Director
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Medical Director
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Medical Director
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Medical Director, Translational Medicine
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Medical Director, Neuroscience Translational
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Novartis Cambridge, United States**About the Role**: · This role is located at our Cambridge, MA site and will not have the ability to be located remotely. · L1-Hybrid · About the role: · More than a billion people are affected by diseases of the nervous system having a dramatic impact on patients and families a ...
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Medical Director
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Medical Director
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Medical Director, Neurology
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Freeline Therapeutics Boston, United States**Benefits**: · - Generous holiday allowance- Life assurance- Gym membership- Medical cover- Pension- Shower at work- Sport clubs- GP consults- Why Freeline? · - Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work ref ...
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Director, Global Medical Research
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Medical Director
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Medical Director
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Executive Director, Medical Director
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Executive Director, Medical Director
1 week ago
Dyne Therapeutics Inc Waltham, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide ther ...
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Executive Director, Medical Director
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Dyne Tx Waltham, United StatesOur commitment to people with muscle diseases · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing m ...
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Executive Director, Medical Director
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Director of Field Medical Excellence
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medical director/executive medical director - Waltham, MA, United States - Dragonfly Therapeutics
Description
Medical Director/Executive Medical DirectorDragonfly Therapeutics seeks a knowledgeable, experienced and motivated individual to join our team and support clinical stage activities. Reporting to the SVP of Clinical Development, this role will be responsible for developing and implementing strategies for efficient high-value clinical development of cancer immunotherapy drug candidates, leading to clinical proof of concept. They will also be responsible for planning, managing, coordinating, and tracking all clinical activities associated with specific clinical development programs for novel drug candidates. Must be hands-on, clinical professional with extensive experience in clinical research/development who is nimble and thrives in a fast-paced, collaborative environment.
Responsibilities:
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
