Senior Medical Director

3 weeks ago


Boston, United States Bicara Therapeutics Full time

Position Overview: The Medical Director/Senior Medical Director in Clinical Development at Bicara Therapeutics will play a pivotal role as the Clinical Lead for multiple oncology clinical trials. This individual will collaborate with cross-functional, multidisciplinary teams to shape clinical development strategies, design and execute clinical trials, provide medical monitoring, and support global regulatory interactions.


Key Responsibilities:


  • Leadership in Clinical Development: Lead cross-functional teams, driving program and clinical strategies to achieve registration in targeted populations and indications.
  • Medical Monitoring: Oversee the design, execution, and interpretation of study data, ensuring patient safety and adherence to Good Clinical Practices (GCP).
  • Document and Analysis Plan Development: Provide scientific and clinical input for study-related documents, including Informed Consent Forms (ICF), Clinical Research Forms (CRF), Statistical Analysis Plans (SAP), and clinical pharmacology and biomarker analysis plans.
  • Regulatory Support: Contribute to regulatory submissions by developing clinical sections of INDs and CTAs, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other relevant documents.
  • Cross-functional Coordination: Act as a liaison between Clinical Development and other internal departments such as clinical operations, pharmacovigilance, manufacturing, quality, and biomarker groups to ensure seamless coordination of study activities.
  • External Collaboration: Build strong relationships with study investigators and external medical experts, representing Bicara Therapeutics at investigator meetings and advisory boards.
  • Advisory Board Planning: Assist in the development and planning of Advisory Board meetings in relevant therapeutic areas.
  • Strategic Planning: Support the development of the Target Product Profile (TPP) and Clinical Development Plan (CDP).


Qualifications:


  • Educational Background: MD, DO, or equivalent ex-US medical degree.
  • Experience: 4-6 years of clinical development experience, including approximately 2 years of clinical trial experience.
  • Industry Experience: Previous experience in the pharmaceutical or biotech industry, particularly in clinical development and medical monitoring.
  • Communication Skills: Excellent oral and written communication skills with the ability to influence and collaborate effectively.
  • Collaborative Mindset: Proven ability to work in a fast-paced, team-based matrix environment and function independently as needed.
  • Problem-solving Skills: Capability to independently resolve challenges and drive projects to completion.
  • Join Bicara Therapeutics and contribute to our mission of advancing oncology treatments through innovative clinical trials and robust clinical development strategies.



  • Boston, United States Ironwood Pharmaceuticals Full time

    Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients.  One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant...


  • Boston, United States Ironwood Pharmaceuticals Full time

    Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients.  One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant...


  • Boston, United States Ironwood Pharmaceuticals Full time

    Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet...


  • Boston, United States Ironwood Pharmaceuticals Full time

    Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet...


  • Boston, United States Vertex Pharmaceuticals, Inc Full time

    Job Description General/Position Summary The Senior Medical Affairs Director, Hematology will be a recognized expert in the field, providing medical and scientific leadership in the Medical Affairs function for our Hematology therapeutic area. This role will report to the Executive Medical Director and will work with a cross-functional group to both align...


  • Boston, United States Vertex Pharmaceuticals, Inc Full time

    Job Description General/Position Summary The Senior Medical Affairs Director, Hematology will be a recognized expert in the field, providing medical and scientific leadership in the Medical Affairs function for our Hematology therapeutic area. This role will report to the Executive Medical Director and will work with a cross-functional group to both align...


  • Boston, United States Bicara Therapeutics Full time

    Position Overview: The Medical Director/Senior Medical Director in Clinical Development at Bicara Therapeutics will play a pivotal role as the Clinical Lead for multiple oncology clinical trials. This individual will collaborate with cross-functional, multidisciplinary teams to shape clinical development strategies, design and execute clinical trials,...


  • Boston, United States Bicara Therapeutics Full time

    Position Overview: The Medical Director/Senior Medical Director in Clinical Development at Bicara Therapeutics will play a pivotal role as the Clinical Lead for multiple oncology clinical trials. This individual will collaborate with cross-functional, multidisciplinary teams to shape clinical development strategies, design and execute clinical trials,...


  • Boston, United States Xenon Pharmaceuticals Inc. Full time

    Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...


  • Boston, United States Xenon Pharmaceuticals Inc. Full time

    Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...


  • Boston, MA, United States Only Medics Full time

    Senior Director Clinical Development Job Type: Permanent Senior Director Clinical Development Neurology (MDD) Location: US, Fully Remote The organization have an extremely advanced and healthy portfolio with multiple assets across phases I-III and are seeking a Senior Director Clinical Development. This novel product pipeline of neurology-focused...


  • Boston, United States Xenon Full time

    Who We Are:Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and...


  • Boston, MA, United States AMN Healthcare Full time

    Seeking a mission-focused physician leader to join Harbor Health Services Inc. as Senior Medical Director in Eastern Massachusetts! The Senior Medical Director, Community Health Centers, will be responsible for the direction and leadership of clinical practices across Harbor Health's Community Health Centers. Reporting to the Senior Vice President (SVP)...


  • Boston, United States Codman Square Health Center Full time

    Job Details Job Location Codman Square Health Center - Dorchester, MA Position Summary: Codman Square Health Center's mission is to be a resource for the physical, mental and social well-being of our community. The Health Center strives to deliver services that support the achievement of its mission, while creating a sustainable care model that adapts to the...


  • Boston, Massachusetts, United States Boston Medical Center (BMC) Full time

    POSITION SUMMARY:Under the direction of the VP of Communications, the Senior Director, Strategic Communications plans and oversees the implementation of comprehensive, integrated communications strategy and tactics to support Boston Medical Center Health System's (BMCHS) long-term goals, including, but not limited to, positioning and amplifying...


  • Boston, MA, United States Bicara Therapeutics Full time

    Position Overview: The Medical Director/Senior Medical Director in Clinical Development at Bicara Therapeutics will play a pivotal role as the Clinical Lead for multiple oncology clinical trials. This individual will collaborate with cross-functional, multidisciplinary teams to shape clinical development strategies, design and execute clinical trials,...


  • Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Clinical Development Senior Medical Director, T1D (Transplant Immunology/Endocrinology) page is loaded Clinical Development Senior Medical Director, T1D (Transplant Immunology/Endocrinology) Apply locations Boston, MA time type Full time posted on Posted 3 Days Ago job requisition id REQ–21783 Job DescriptionGeneral Summary:The Senior Medical Director,...


  • Boston, MA, United States AMN Healthcare Full time

    Job Details Seeking a mission-focused physician leader to join Harbor Health Services Inc. as Senior Medical Director in Eastern Massachusetts! The Position The Senior Medical Director, Community Health Centers, will be responsible for the direction and leadership of clinical practices across Harbor Health's Community Health Centers. Reporting to the...


  • Boston, United States Alexion Pharmaceuticals, Inc. Full time

    This is what you will do: The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...


  • Boston, United States Alexion Pharmaceuticals, Inc. Full time

    This is what you will do: The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...