Clinical Development Associate Medical Director, Type 1 Diabetes

4 weeks ago


Boston, Massachusetts, United States Vertex Pharmaceuticals Full time
Clinical Development Associate Medical Director, Type 1 Diabetes

Job Description

General Summary:

The Clinical Development Associate Medical Director will serve as the Medical Lead for clinical trials, working with cross–functional teams on trial strategy, design, execution, and reporting. In addition to oversight and accountability for the study as a whole, this role will serve as the internal primary Medical Monitor accountable for monitoring the safety of enrolled subjects and ensuring scientific integrity. The incumbent may participate in other projects to support the clinical development program.

Key Duties and Responsibilities:

Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key documents in conjunction with other line functions and with minimal guidance.Serves on cross–functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high–quality study execution.Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.Provides scientific and clinical input to study–related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reports.Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies.Represents Vertex to outside medical personnel in the development of clinical protocols, in study conduct, and in external reporting of study results.Performs other duties as assigned related to other aspects of Clinical Development.Travel: 20%.Knowledge and Skills:Strong oral and written communication skills.Ability to work collaboratively in a fast–paced, team–based matrix environment and to function independently as appropriate.Global clinical research experience and experience interacting with regulatory authorities is a plus.Working familiarity with analysis of research data, biostatistics, pharmacology and pharmacokinetics, international standards for Good Clinical Practice (GCP), clinical study design, ethics committee/Institutional Review Board review, preparation of manuscripts, abstract/posters, and oral presentations, overall drug/device clinical development.Board certification/eligibility, as well as clinical training in a relevant medical specialty is highly desired.Education and Experience:MD, DO or equivalent ex–US medical degree.8 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience.Flex Designation: In this Hybrid–Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On–Site: work five days per week on–site with ad hoc flexibility.Company Information Vertex is a global biotechnology company that invests in scientific innovation.

  • Boston, Massachusetts, United States Nimbus Therapeutics, Inc. Full time

    Senior Medical Director, Clinical Development (Oncology) Nimbus has an outstanding opportunity for a Senior Medical Director, Clinical Development to join our team. This person will serve as the primary Medical Monitor on a first–in–human study, establishing all the relevant relationships with site staff, CRO and relevant vendors. They are responsible...


  • Boston, Massachusetts, United States Medical Director Services PC Full time

    Job Summary:Medical Director Services PC is seeking an experienced Podiatrist to provide professional and medical podiatric services to patients with conditions affecting the foot, ankle, and related structures in skilled nursing facilities throughout Massachusetts. Inquire about availability in other states as well.Key Responsibilities:Provide essential...


  • Boston, Massachusetts, United States AbbVie Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...


  • Boston, Massachusetts, United States American Heart Association Full time

    OverviewAs we celebrate our Centennial year, we invite you to join us in shaping the next century of impact. Be a relentless force for a world of longer, healthier lives. Here at the American Heart Association, you matter and so does your career.The American Heart Association has an excellent opportunity for a Development Director, Boston covering the Boston...


  • Boston, Massachusetts, United States Suffolk University Full time

    About the RoleSuffolk University is seeking an experienced professional to serve as the Associate Director of Alumni Engagement and Development. This key role will be responsible for planning and implementing a variety of community-building, educational, and professional programs to successfully engage students and recent graduates with the university.Key...

  • Medical Director

    3 weeks ago


    Boston, Massachusetts, United States Proclinical Full time

    The successful candidate will be a key member of the clinical development team, contributing to both early and late-stage clinical studies. We value excellent communication skills, meticulous attention to detail, and the ability to thrive independently in a dynamic and innovative environment. This role is pivotal in advancing our clinical development...


  • Boston, Massachusetts, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Boston, Massachusetts, United States Department Of Veterans Affairs Full time

    Summary This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific individual eligibility requirements in accordance with VHA policy and submit your EDRP application within four months of appointment. Approval, award amount (up to $200,000) and eligibility period (one to...


  • Boston, Massachusetts, United States Boston University Full time

    The Director of Organizational Development and Learning in the Office of the Vice President and Associate Provost for Community and Inclusion will lead all aspects of Organizational Development and Learning for Boston University's 10,000 staff and faculty. The Director will join BU at a crucial time as the University looks to the future, aligning the OD&L...


  • Boston, Massachusetts, United States Boston Medical Center Full time

    About the RoleWe are seeking an exceptional clinician, leader, and innovator to serve as the Director of Hospital Medicine at Boston Medical Center. This is a unique opportunity to lead innovative program development and manage clinical operations for the Hospital Medicine Unit, reporting jointly to the Chief of General Internal Medicine and the Chief...


  • Boston, Massachusetts, United States Medical Director Services PC Full time

    Medical Director Services PC is seeking qualified Podiatrists to provide care in our skilled nursing facilities across Massachusetts. Incentives: We are pleased to offer a sign-on bonus for eligible candidates. Position Overview: As a Podiatrist, you will deliver comprehensive podiatric care to patients experiencing issues related to the foot, ankle, and...

  • Research Scientist

    5 days ago


    Boston, Massachusetts, United States Massachusetts General Hospital Full time

    Job SummaryThe Massachusetts General Hospital is seeking a highly skilled Research Scientist to join their team and contribute to their mission to improve health outcomes for pregnant and lactating individuals and their children. Working under the guidance of Dr. Camille E. Powe and the Diabetes Research Center Management, the Research Scientist will provide...


  • Boston, Massachusetts, United States Takeda Full time

    About the Role:Takeda, a leading pharmaceutical company, is seeking a highly skilled and experienced Biomarker Technology and Science Lead to join our team. As a key member of our Bioanalytical and Biomarker Sciences and Technologies (BST) department, you will play a critical role in the development and implementation of biomarkers for clinical trials.Key...

  • Clinical Director RN

    5 hours ago


    Boston, Massachusetts, United States Tufts Medical Center Full time

    Job SummaryTufts Medical Center is seeking a highly skilled Clinical Leader RN to oversee daily clinical and administrative operations of designated units or services. This role requires a registered nurse with three years of demonstrated clinical nursing practice, including progressive leadership responsibilities.Key ResponsibilitiesContribute to an...


  • Boston, Massachusetts, United States Cabot Corporation Full time

    About the RoleCabot Corporation is seeking an experienced Associate Director to lead our Business Development and Partnerships efforts in the Sustainable Solutions Business. This is an exciting opportunity to join a dynamic team and contribute to the company's growth and profitability objectives.The Associate Director will be responsible for driving...


  • Boston, Massachusetts, United States Joslin Diabetes Center Full time

    The Senior Financial Analyst within the Fiscal Services department plays a crucial role in providing financial and administrative assistance in the management of sponsored awards, grants, and contracts within the Research Finance Office (RFO). This position involves processing journal entries, reviewing sponsored agreements, and generating financial reports...


  • Boston, Massachusetts, United States Massachusetts General Hospital Full time

    Clinical Research Specialist OverviewThe Diabetes in Pregnancy Research Program is in search of a committed Clinical Research Specialist to become a vital part of their team, dedicated to enhancing health outcomes for pregnant and lactating individuals and their offspring. Under the mentorship of Dr. Camille E. Powe and the management of the Diabetes...


  • Boston, Massachusetts, United States PepGen Full time

    Associate Director, Quality Control Reporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen's pipeline. In addition, this position will be required to actively support the preparation of regulatory...


  • Boston, Massachusetts, United States AbbVie Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...


  • Boston, Massachusetts, United States OPEN Health Full time

    Job OverviewThe Senior Director of Medical Strategy is a key figure in steering the strategic medical initiatives within OPEN Health's Scientific Communications division. This position is responsible for leading the creation of detailed Medical Affairs strategies and their associated medical plans. The Senior Director will also nurture and strengthen vital...