Executive Medical Director/VP of Clinical Development

6 days ago

Waltham, United States Dragonfly Therapeutics, Inc. Full time

Executive Medical Director/VP of Clinical Development

Dragonfly Therapeutics seeks a knowledgeable, experienced and motivated individual to join our team and support clinical stage activities. Reporting to the Head of Clinical Development, this role will be responsible for developing and implementing strategies for efficient high-value clinical development of inflammation and immunology drug candidates, leading to clinical proof of concept. He/she 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 a hands-on, clinical operations professional with extensive experience in clinical research who is nimble and thrives in a fast-paced, collaborative environment.

Responsibilities: Lead the Clinical Development planning and strategy for Dragonfly's I&I portfolio Lead and demonstrate ownership of early stage (phase 1-2) clinical trial design for novel, first-in-class immune engagers for treatment of inflammation and immunology 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 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, KOL's, 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 for due diligence or other business development activity Qualifications:

MD or MD/PhD, with at least 7-10 years successful track record in biotech or pharma in Medical Director roles in inflammation and immunology (title commensurate with experience) Significant pharmaceutical drug development experience gained through front-line involvement in development of drugs to clinical PoC, and preferably to the market, in the US or EU Ability to run a complex clinical research program with minimal direction Extensive 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 inflammation or immunotherapy involving cytokines or other immune modulators Proven leadership skills, work well with others, and ability to bring out the best in others on a cross- functional team; highly collaborative, team oriented and decisive Excellent communication and presentation skills are essential Willingness to travel to clinical sites and home office as required and necessary in support of the project(s) Must live within driving distance of Waltham, and be willing to work on-site at 4 days/week

About Dragonfly

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. #J-18808-Ljbffr

  • Executive Director/VP, Clinical Development

    2 months ago

    Waltham, United States Zenas BioPharma Full time

    Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas...

  • Executive Director/VP, Clinical Development

    3 weeks ago

    Waltham, United States Zenas BioPharma Full time

    Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas...

  • Senior Medical Director, Clinical Development

    4 weeks ago

    Waltham, United States CURE Full time

    Senior Medical Director, Clinical Development 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...

  • Senior Medical Director, Clinical Development

    4 weeks ago

    Waltham, United States DynamiCure Biotechnology Full time

    Job DescriptionJob DescriptionSenior 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...

  • Senior Medical Director, Clinical Development

    4 weeks ago

    Waltham, United States DynamiCure Biotechnology Full time

    Job DescriptionJob DescriptionSenior 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...

  • Senior Medical Director, Clinical Development

    4 weeks ago

    Waltham, United States DynamiCure Biotechnology Full time

    Senior Medical Director, Clinical DevelopmentDynamiCure 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...

  • Senior Medical Director, Clinical Development

    3 weeks ago

    Waltham, United States DynamiCure Biotechnology Full time

    Senior Medical Director, Clinical DevelopmentDynamiCure 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...

  • Senior Medical Director, Clinical Development

    3 weeks ago

    Waltham, United States DynamiCure Biotechnology Full time

    Job DescriptionJob DescriptionSenior 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...

  • Medical Director/Clinical VP

    4 weeks ago

    Waltham, United States Alchemab Full time

    Job DescriptionJob DescriptionSalary: The Role  Reporting to the SVP of Development, this role will drive clinical development strategies for therapeutic antibodies in neurological disorders including Huntington’s Disease, ALS and Fronto Temporal Dementia. The Medical Director will be pivotal in shaping clinical trial strategy and execution, serving as...

  • Medical Director/Clinical VP

    4 weeks ago

    Waltham, United States Alchemab Full time

    Job DescriptionJob DescriptionSalary: The Role  Reporting to the SVP of Development, this role will drive clinical development strategies for therapeutic antibodies in neurological disorders including Huntington’s Disease, ALS and Fronto Temporal Dementia. The Medical Director will be pivotal in shaping clinical trial strategy and execution, serving as...

  • Medical Director/Clinical VP

    3 weeks ago

    Waltham, United States Alchemab Full time

    Job DescriptionJob DescriptionSalary: The Role  Reporting to the SVP of Development, this role will drive clinical development strategies for therapeutic antibodies in neurological disorders including Huntington’s Disease, ALS and Fronto Temporal Dementia. The Medical Director will be pivotal in shaping clinical trial strategy and execution, serving as...

  • Associate Director, Clinical Data

    5 days ago

    Waltham, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple,...

  • Late Clinical Development, Medical Director

    4 weeks ago

    Waltham, United States AstraZeneca Full time

    Job DescriptionThe Late Phase Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally, in a matrixed environment, with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The Global...

  • Executive Assistant

    2 weeks ago

    Waltham, United States Ophthalmic Consultants of Boston Full time

    Job DescriptionJob DescriptionOphthalmic Consultants of Boston (OCB) is currently searching for a dynamic Executive Assistant to join our team. The Executive Assistant provides high level administrative and organizational support to the Chief Operating Officer (COO), VP of Finance, VP of Human Resources, VP of Operations and VP of Revenue Cycle. As a...

  • Executive Director, Clinical Development

    13 hours ago

    Waltham, MA, United States Alkermes Full time

    This is a high impact position with great visibility across all levels of the Alkermes organization. The primary role is to drive Alkermes’s clinical development portfolio in neurology.   Specifically, this position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for neurology...

  • Executive Director, Clinical Development

    2 months ago

    Waltham, United States Alkermes Full time

    Position Overview This is a high impact position with great visibility across all levels of the Alkermes organization. This position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for neurology indications, including sleep disorders. Key domains include development of study...

  • Executive Director, Clinical Development

    3 weeks ago

    Waltham, United States Alkermes Full time

    Position Overview This is a high impact position with great visibility across all levels of the Alkermes organization. This position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for neurology indications, including sleep disorders. Key domains include development of study...

  • Associate Director, Clinical Data

    4 days ago

    North Waltham, United States Clinical Dynamix, Inc. Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start–up and execution of multiple,...

  • Executive Director, Medical Director

    2 months ago

    Waltham, United States Dyne Therapeutics Full time

    Company 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 therapeutics that are designed to overcome limitations in delivery to muscle...

  • Executive Director, Medical Director

    3 weeks ago

    Waltham, United States Dyne Therapeutics Full time

    Company 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 therapeutics that are designed to overcome limitations in delivery to muscle...