Jobs
>
Cambridge

    Associate Director Clinical Science - Cambridge, United States - Bridgeway Professionals Inc

    Bridgeway Professionals Inc
    Bridgeway Professionals Inc Cambridge, United States

    1 week ago

    Default job background
    Description
    Global Biotech company with US Headquarters outside Boston, MA is expanding. Looking for Dynamic Leader to work hybrid (out of Lexington, MA office) 2 or 3 days a week

    The role of AD, Clinical Science is to guide and participate in all aspects of clinical development and study management.

    Reporting to the CMO and a high profile role.

    Responsible for Scientific input and writing, Clinical Evaluation planning, collaboration with key stakeholders and working with the head of clinical development.

    Leadership role responsibilities include scientific support to planned and ongoing clinical trials. May support more than one clinical protocol and portfolio. Works cross-functionally to ensure alignment across studies and to achieve the corporate objectives for programs.
    Main Areas of Responsibilities
    Authors, individually or in collaboration with internal and external partners, clinical materials, included but not limited to:
    Clinical Investigation Plans and Synopses based on completed Study Designs
    Patient Informed Consents
    Clinical Study Reports
    Clinical Evaluation Plans and Reports
    Clinical Literature Review Reports
    Additional Author additional clinical materials as needed
    Annual Reports and when needed, ISE/ISS
    Assist with reviewing topline results and preparing presentations for senior management as needed.
    Contributes to, and reviews relevant documents and plans, including but not limited to:
    Monitoring plan
    Statistical analysis plan.
    Reviews, tests, and approves specifications and edit checks for internal and external systems such as EDC and IVRS. As needed, reviews and trends clinical queries.
    Monitors and reviews aggregate clinical data for trends/errors during the course of assigned studies. Identifies potential clinical data issues and recommends to management means of risk mitigation. Collaborates with Medical Affairs and Clinical Affairs in the review and management of safety related observations and issues.
    Interacts with R&D and Clinical Operations to ensure adequate clinical supplies for the clinical trial. Oversees the shipment of Investigational Product supply, packaging, and labeling.
    Supports planning and conduct of investigator meetings, Advisory Boards, Steering Committees, and DMCs
    . Develop and deliver study specific training presentations as needed.
    Provides support of publications

    • Works with Project Management to establish, report, and update timelines and budgets.
    • Support the development and management of study budgets for clinical programs. Track and manage site budgets efficiently and provide timely resolution to financial inquires.
    • Evaluates potential vendors. Work with Contracts Management/Procurement to receive/review bid proposals, meet vendors, and contribute to vendor specifications development. Address any escalated issues related to contract negotiations as needed.
    • Contributes to the development and review of SOPs, training guidances, and templates as needed.
    May manage direct reports or supervise clinical study team member(s) as assigned. Recruits, develops, and supervises direct report(s). Conducts employee performance evaluations and provides direct report(s) with guidance on technical/project related issues and employee relations. Mentors and guides junior staff members to maintain team morale and high quality of deliverables.
    May develop and deliver training related to study execution and COMPANY policy and procedures within department and cross-functionally.
    Contributes to process improvement.
    May perform additional research and contribute to submissions activities and/or responses to FDA inquiries as needed.
    Education and Background Requirements
    10 years of experience in Medical Technology Industry or Biotechnology Industry
    PharmD, PhD, or MPH Preferred
    Must have managed team in past and have strategy experience
    Demonstrated experience supporting and managing the development, implementation, and completion of clinical trials and/or programs
    Experience with all stages of clinical development
    Site/vendor management and data review experience
    Knowledge of medical device development and relevant regulations, including but not limited to, FDA GCP/ICH regulatory guidelines
    Strong understanding of clinical trial design and basic knowledge of statistics
    Proficiency with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat

    Must possess excellent skill/ability in the following:
    Oral and Written Communication
    Planning and Organizing
    Decision Making, Judgment, and Problem Solving
    People Relationships, Team Building, Motivating Employees, and Influencing Others
    PEACE BEGINS WITH A SMILE – Mother Teresa

    FOR IT IS IN GIVING THAT WE RECEIVE – Francis of Assisi
    FAITH IS TAKING THE FIRST STEP EVEN WHEN YOU DON'T SEE THE WHOLE STAIRCASE – Martin Luther King, Jr.
    LET ME WIN, BUT IF I CANNOT WIN, LET ME BE BRAVE IN THE ATTEMPT – Motto of the Special Olympics
    NEVER TELL PEOPLE HOW TO DO THINGS. TELL THEM WHAT TO DO AND THEY WILL SURPRISE YOU WITH THEIR INGENUITY. – General George S Patton
    WE CAN'T HELP EVERYONE, BUT EVERYONE CAN HELP SOMEONE – Ronald Reagan
    THERE IS ONLY ONE WAY TO SUCCEED AT ANYTHING AND THAT IS TO GIVE EVERYTHING – Vince Lombardi
    NO ONE IS USELESS IN THIS WORLD WHO LIGHTENS THE BURDEN OF IT TO ANYONE ELSE – Charles Dickens
    LIFE IS 10% WHAT HAPPENS TO YOU AND 90% HOW YOU RESPOND TO IT – Lou Holtz
    ONE LEARNS PEOPLE THROUGH THE HEART, NOT THE EYES OR THE INTELLECT – Mark Twain
    BE THE CHANGE YOU WISH TO SEE IN THE WORLD – Mahatma Gandhi

    #J-18808-Ljbffr
  • Foghorn Therapeutics Inc.

    Director, Clinical Science

    1 week ago

    Foghorn Therapeutics Inc. Cambridge, United States

    Our Culture: Why work with us? · At Foghorn Therapeutics, we believe in "People First, Mission Always." · We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    1 week ago

    Bristol-Myers Squibb Cambridge, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    2 hours ago

    Bristol-Myers Squibb Cambridge, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    2 weeks ago

    Bristol-Myers Squibb Cambridge, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    1 week ago

    Bristol-Myers Squibb Cambridge, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Bristol-Myers Squibb

    Clinical Science Lead

    2 weeks ago

    Bristol-Myers Squibb Cambridge, United States

    **Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...

  • Solid Biosciences

    Director, Clinical Science

    1 week ago

    Solid Biosciences Charlestown, United States

    Job Title: · Director, Clinical Science · Reports to (title): · Senior Director, Clinical Science · Summary: · Solid Biotechnology is seeking a Director, Clinical Science to aid in the development of clinical strategy and lead the execution of clinical development. Clinical Scien ...

  • BlueRock Therapeutics

    Associate Director, Clinical Sciences

    1 week ago

    BlueRock Therapeutics Cambridge, United States

    The Associate Director, Clinical Sciences, Ophthalmology will be charged with providing medical and scientific support for BlueRock's Ophthalmology programs. Reporting to the Senior Director, Clinical Development, Ophthalmology, this role will work closely with clinical and progr ...

  • The Steely Group

    Sr. Manager, Clinical Science

    2 hours ago

    The Steely Group Cambridge, United States

    Reporting to the Director, Clinical Science, the purpose of the Senior Manager, Clinical Science role is to utilize the clinical development strategy to determine the efficacy and safety of candidate drug products in clinical development based on the Clinical, Manager, Science, C ...

  • Agios Pharmaceuticals

    Associate Director, Clinical Science

    5 days ago

    Agios Pharmaceuticals Cambridge, United States

    Associate Director, Clinical Science Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply Director, Clinical, Science, ...

  • ONO PHARMA USA

    Sr. Manager, Clinical Science

    1 day ago

    ONO PHARMA USA Cambridge, United States

    Responsibilities: · Utilizing company's clinical development strategy, while complying with pharmaceutical industry practices and regulatory guidelines, serves as a Sr. Manager of Clinical Science (Clinical Science Lead, Immunology) on the Clinical Research and Development team, ...

  • The Steely Group

    Sr. Manager, Clinical Science

    1 week ago

    The Steely Group Cambridge, United States

    Posted: · 09/22/2023 · Employment Type: · Direct Hire · Job Category: · Operations and Development · Job Number: · 3668 · Job Description · Reporting to the Director, Clinical Science, the purpose of the · Senior Manager, Clinical Science · role is to utilize the clinic ...

  • The Steely Group

    Sr. Manager, Clinical Science

    1 week ago

    The Steely Group Cambridge, United States

    Posted: · 09/22/2023 · Employment Type: · Direct Hire · Job Category: · Operations and Development · Job Number: · 3668 · Job Description · Reporting to the Director, Clinical Science, the purpose of the · Senior Manager, Clinical Science · role is to utilize the clini ...

  • ITech Consulting Partners

    Associate Director Clinical Science

    1 week ago

    ITech Consulting Partners Cambridge, United States

    Associate Director, Clinical Monitoring Oversight · Apply · Location · Cambridge, MA · Hybrid · Type · Direct Hire · ID · BN · Posted · Feb 5, 2024 · Global Biotech company with US Headquarters outside Boston, MA is expanding. Looking for Dynamic Leader to work remotely (pos ...

  • Corps Partners

    Associate Director Clinical Science

    1 week ago

    Corps Partners Cambridge, United States

    Associate Director, Clinical Monitoring Oversight · Apply · Location · Cambridge, MA · Hybrid · Type · Direct Hire · ID · BN · Posted · Feb 5, 2024 · Global Biotech company with US Headquarters outside Boston, MA is expanding. Looking for Dynamic Leader to work remotely (pos ...

  • Cameron Craig Group

    Associate Director Clinical Science

    1 week ago

    Cameron Craig Group Cambridge, United States

    Associate Director, Clinical Monitoring Oversight · Apply · Location · Cambridge, MA · Hybrid · Type · Direct Hire · ID · BN · Posted · Feb 5, 2024 · Global Biotech company with US Headquarters outside Boston, MA is expanding. Looking for Dynamic Leader to work remotely (pos ...

  • Lyra Therapeutics, Inc.

    director, clinical sciences

    1 week ago

    Lyra Therapeutics, Inc. Waltham, MA, United States

    Apply · Description · Lyra Therapeutics (Nasdaq: LYRA) is a late clinical stage company developing medicines precisely designed to target ear, nose, and throat (ENT) diseases. Our goal is to transform the ENT treatment paradigm by providing effective solutions for physicians and ...

  • Lyra Therapeutics

    Director, Clinical Sciences

    3 days ago

    Lyra Therapeutics Waltham, United States

    Lyra Therapeutics (Nasdaq: LYRA) is a late clinical stage company developing medicines precisely designed to target ear, nose, and throat (ENT) diseases. Our goal is to transform the ENT treatment paradigm by providing effective solutions for physicians and new treatment options ...

  • Scorpion Therapeutics

    Director/Sr. Director, Clinical Science

    2 weeks ago

    Scorpion Therapeutics Boston, MA, United States

    Job Summary · Our Clinical Development team has an exciting new opportunity for someone to join as a Director/Senior Director, Clinical Science (Early Development). This person will provide scientific and clinical expertise to develop, design, conduct, analyze, and report global ...

  • Partners Healthcare System

    sr. director, enterprise clinical data science

    1 week ago

    Partners Healthcare System Somerville, MA, United States

    General Summary/Overview · If you are passionate about leveraging data science to drive transformative changes in healthcare, and if you possess the expertise to lead a dynamic team in creating impactful solutions, we invite you to apply for this exciting opportunity as the Senio ...