Executive Medical Director, Clinical Development
4 days ago
We're partnered with a Pharmaceutical company to source an Executive Medical Director, they are currently focused on advancing a large early Oncology pipeline spanning several innovative technology platforms for more than a dozen tumor types.
If you're interested in this type of mission and would enjoy working in a fast paced environment look further down for more details...
Key Responsibilities:
- Participate in the development of product development plans and lead clinical trial strategy for given project/program
- Serve as an internal clinical expert in translational and clinical oncology.
- Ensures projects/programs are delivered in compliance with GCP requirements and global ethical and regulatory standards
- Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials
- Participate in pharmacovigilance activities including SAE evaluation and reporting and analysis of safety data
- Ensure appropriate training, recruitment, and development requirements for matrix team resources.
- Participate in preparation of protocols , Investigator Brochures, clinical study reports, safety reports, and the clinical sections of Annual Reports , INDs / IMPDs , NDAs / MAAs , SOPs , pediatric investigation plans , as well as abstracts and manuscripts
Experience/Knowledge:
- Experience with Regulatory Authorities such as FDA and/or EMA
- Cross functional team collaboration experience
- Experience in early to late phase clinical trials (phase 1, 2 and 3)
Requirements:
- Medical Degree (M.D) and Board Certified in Oncology (Preferred)
- 5+ years experience in Clinical Development within the pharmaceutical industry
- Willing to travel to Cambridge, Massachusetts on a hybrid basis
-
cambridge, United States ARTO Full timeWe're partnered with a Pharmaceutical company to source an Executive Medical Director, they are currently focused on advancing a large early Oncology pipeline spanning several innovative technology platforms for more than a dozen tumor types.If you're interested in this type of mission and would enjoy working in a fast paced environment look further down for...
-
Medical Director, Clinical Sciences
3 weeks ago
Cambridge, United States Takeda Full timeThe Director Clinical Science - M.D. is responsible for providing strategic direction and oversight in clinical research, ensuring the successful execution of major initiatives. This role focuses on designing clinical studies, managing safety protocols, and interpreting complex clinical data to support drug or device approvals.How you will contribute:*...
-
Medical Director, Clinical Sciences
3 weeks ago
cambridge, United States Takeda Full timeThe Director Clinical Science - M.D. is responsible for providing strategic direction and oversight in clinical research, ensuring the successful execution of major initiatives. This role focuses on designing clinical studies, managing safety protocols, and interpreting complex clinical data to support drug or device approvals.How you will contribute:*...
-
Medical Director, Clinical Sciences
2 weeks ago
Cambridge, United States Takeda Full timeThe Director Clinical Science - M.D. is responsible for providing strategic direction and oversight in clinical research, ensuring the successful execution of major initiatives. This role focuses on designing clinical studies, managing safety protocols, and interpreting complex clinical data to support drug or device approvals.How you will contribute:*...
-
Clinical Trials Director
4 weeks ago
Cambridge, Massachusetts, United States Garuda Therapeutics, Inc. Full timeJob DescriptionWe are seeking a highly skilled Clinical Trials Director to lead the planning, implementation, and execution of global clinical trials. As a key member of our team, you will be responsible for managing clinical trials from start-up through close-out, ensuring that all components of the trial deliverables are executed to specified quality...
-
Director, Dermatology, US Medical Lead
1 month ago
Cambridge, Massachusetts, United States Takeda Full timeAbout the Role:Takeda is seeking a highly skilled and experienced Medical Director to lead our Dermatology, US Medical Affairs team. As a key member of our US Medical Affairs organization, you will be responsible for developing and executing medical strategies for our dermatology products, working closely with cross-functional teams to drive business growth...
-
Medical Director, Medical Affairs
3 weeks ago
cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
Medical Director, Medical Affairs
3 weeks ago
cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
Medical Director, Medical Affairs
2 weeks ago
Cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
Medical Director, Medical Affairs
3 weeks ago
Cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
Senior Director of Clinical Operations
4 weeks ago
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeJob DescriptionJob Title: Senior Director, Clinical OperationsCompany: Akebia TherapeuticsJob SummaryAkebia Therapeutics is seeking a highly experienced Senior Director, Clinical Operations to lead our clinical development programs. The successful candidate will have a strong background in clinical trial management, with a proven track record of delivering...
-
Clinical Development Scientist
1 month ago
cambridge, United States Integrated Resources, Inc ( IRI ) Full timeJob Title: Clinical Development ScientistJob Location: Bothell, WA/ Cambridge, MA- HybridJob Duration: 8+ monthsYou are responsible for:Leading the development of evidence generation strategies for assigned projects, working within a cross-functional team, in line with the value proposition that addresses the evidence needs of all key stakeholdersDelivery of...
-
Clinical Development Scientist
2 months ago
Cambridge, United States Integrated Resources, Inc ( IRI ) Full timeJob Title: Clinical Development ScientistJob Location: Bothell, WA/ Cambridge, MA- HybridJob Duration: 8+ monthsYou are responsible for:Leading the development of evidence generation strategies for assigned projects, working within a cross-functional team, in line with the value proposition that addresses the evidence needs of all key stakeholdersDelivery of...
-
Director of Dermatology Medical Strategy
1 month ago
Cambridge, Massachusetts, United States Takeda Pharmaceutical Company Ltd Full timeAbout the Role:Takeda Pharmaceutical Company Ltd is seeking a highly skilled and experienced professional to fill the position of Director of Dermatology Medical Strategy. As a key member of the US Medical Affairs team, this individual will be responsible for developing and executing medical strategies for dermatology products, ensuring alignment with...
-
HQI Executive Director
7 months ago
Cambridge, United States Harvard University Full time• In consultation with the Faculty Co-Directors and Faculty Executive Committee, develop and implement the short-, medium-, and long-term strategic plans and identify potential roadblocks that might impede their execution.• Serve as an expert source of information and the primary point of programmatic contact for faculty and other program participants...
-
Cambridge, Massachusetts, United States Biogen Full timeAbout the RoleThe Medical Director - Alzheimer's role is a key position within Biogen's US Medical Affairs team, responsible for supporting the development and implementation of the US Medical Strategy for Alzheimer's. This strategic partner helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes.This...
-
Medical Director, Clinical Sciences
3 weeks ago
Cambridge, MA, United States Takeda Full timeThe Director Clinical Science - M.D. is responsible for providing strategic direction and oversight in clinical research, ensuring the successful execution of major initiatives. This role focuses on designing clinical studies, managing safety protocols, and interpreting complex clinical data to support drug or device approvals.How you will contribute:*...
-
Clinical Development Leader
4 weeks ago
Cambridge, Massachusetts, United States Sarepta Therapeutics, Inc. Full timeThe Director, Clinical Development is responsible for leading a clinical sciences team responsible for advancing Sarepta's clinical-stage programs. The individual is responsible for defining strategic priorities for the program and integrating cross-functional input in order to develop and execute the clinical development plan. The individual may be called...
-
Associate Director, Medical Communications
4 days ago
Cambridge, United States Integrated Resources, Inc ( IRI ) Full timeCan be hybrid in Cambridge, MA or Bridgewater, NJTitle: Associate Director –Global Scientific Communications Innovation Lead, Oncology This role reports into the Global Medical Oncology team that is part of the Medical Specialty Care organization serving as a key strategic partner with commercial, regulatory, clinical, and market access on therapeutic...
-
Associate Director, Medical Communications
4 days ago
Cambridge, United States Integrated Resources, Inc ( IRI ) Full timeCan be hybrid in Cambridge, MA or Bridgewater, NJTitle: Associate Director –Global Scientific Communications Innovation Lead, Oncology This role reports into the Global Medical Oncology team that is part of the Medical Specialty Care organization serving as a key strategic partner with commercial, regulatory, clinical, and market access on therapeutic...