- Contribute to oversight of trials in start-up, conduct, and close-out, for Phase I-III in close coordination with Clinical Operations
- Participate in critical site-facing activities (PSVs, SIVs, etc.); contribute to preparation of meeting materials in collaboration with the Clinical Trial Lead.
- Coordinate and conduct regular data/safety/efficacy reviews and identify trends across programs in collaboration with the Global Medical Monitor
- Contribute to the cross functional trial team as the clinical sciences lead.
- Participate with the study team to prepare for and execute regulatory milestones
- Contribute to the development of study documents for activities around study conduct (e.g., protocols, IBs, eCRFs, meeting abstracts, manuscripts, RECIST/IWG training materials), regulatory requirements (e.g., briefing documents), and IDMCs (e.g., charters)
- Work with statisticians/biometrics to develop the required tables/listings/figures and contribute to the interpretation of efficacy and safety data from clinical trials.
- Present safety findings and study status to internal stakeholders (e.g., safety working group/senior management meetings)
- Coordinate presentations at IDMC meetings, and other meetings, such as Investigator and Safety Review Meetings
- Participate in various initiatives and duties as required by the clinical development program.
- Advanced degree (PharmD, MD, DO, PA, NP, PhD, etc.) in science is required, and 3+ years of experience in clinical research and/or drug development within the pharmaceutical industry.
- Prior drug development experience in oncology is preferred
- Experience using Medidata EDC and data visualization programs (e.g., R-Shiny, SAS, SpotFire, Tableu, Excel Pivot Tables, etc.) is preferred
- Experience in developing relationships with key investigators and KOLs
- Knowledge of GCP/ICH, study design, statistics, and basic clinical operations required
- Experience writing, editing, and reviewing protocols, informed consent templates, study manuals, conference presentations, and journal publications
- Team oriented, goal-driven, organized, and highly collaborative
- Excellent written and oral communication skills
- Ability to adapt in a fast-paced, agile team environment
-
Clinical Science Lead
Found in: Lensa US 4 C2 - 1 day 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 ...
-
clinical science lead
Found in: Careerbuilder One Red US C2 - 1 day ago
Bristol Myers Squibb Cambridge Crossing, Jacobs St, Cambridge, MA , USA, United StatesWorking 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 lin ...
-
Clinical Science Lead
Found in: Lensa US 4 C2 - 3 days 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 ...
-
Clinical Science Lead
Found in: Lensa US 4 C2 - 2 days 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 ...
-
Clinical Science Lead
Found in: Lensa US 4 C2 - 7 hours 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 ...
-
Sr. Manager, Clinical Science
Found in: Lensa US 4 C2 - 3 days ago
The Steely Group Cambridge, United StatesPosted: · 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 ...
-
Sr. Manager, Clinical Science
Found in: Appcast Linkedin GBL C2 - 3 days ago
ONO PHARMA USA Cambridge, United StatesResponsibilities: · 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, ...
-
Associate Director Clinical Science
Found in: Lensa US 4 C2 - 3 days ago
Corps Partners Cambridge, United StatesAssociate 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 ...
-
Associate Director Clinical Science
Found in: Lensa US 4 C2 - 3 days ago
ITech Consulting Partners Cambridge, United StatesAssociate 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 ...
-
Associate Director Clinical Science
Found in: Lensa US 4 C2 - 2 days ago
Bridgeway Professionals Inc Cambridge, United StatesGlobal 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 ...
-
Associate Director Clinical Science
Found in: Lensa US 4 C2 - 3 days ago
Cameron Craig Group Cambridge, United StatesAssociate 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 ...
-
Director/Sr. Director, Clinical Science
Found in: Jooble US O C2 - 6 days ago
Atlas Venture Boston, MA, United StatesDirector/Sr. Director, Clinical Science (Early Oncology Development) · Company Address: 1 Winthrop Square, Suite 400, Boston, MA, 02110 · About Scorpion Therapeutics · Scorpion Therapeutics was founded to expand the reach of precision medicine to more people with cancer. The c ...
-
Director, Clinical Sciences
Found in: Careerbuilder One Red US C2 - 2 days ago
Lyra Therapeutics Waltham, United StatesApply · 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 an ...
-
Director, Clinical Sciences
Found in: Lensa US 4 C2 - 3 days ago
Lyra Therapeutics Waltham, United StatesLyra 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 ...
-
Clinical Assistant Professor of Health Sciences Health Data Science Sargent College of Health R
Found in: Jooble US O C2 - 3 days ago
OSI Group Boston, MA, United StatesAs one of the country's leading schools of health and rehabilitation sciences, Sargent College is committed to an interdisciplinary and collaborative approach to designing and delivering quality healthcare. We believe that the cultural and social diversity of our faculty, staff a ...
-
Clinical Assistant Professor of Health Sciences Health Data Science Sargent College of Health R
Found in: Jooble US O C2 - 3 days ago
OSI Group Boston, MA, United StatesAs one of the country's leading schools of health and rehabilitation sciences, Sargent College is committed to an interdisciplinary and collaborative approach to designing and delivering quality healthcare. We believe that the cultural and social diversity of our faculty, staff a ...
-
Director Clinical Science
Found in: Careerbuilder One Red US C2 - 1 day ago
Lantheus Bedford, United StatesLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. ...
-
Senior Medical Director, Clinical Science, Marketed Products Development
Found in: Careerbuilder One Red US C2 - 3 days ago
Takeda Pharmaceuticals Cambridge, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
-
Senior Medical Director, Clinical Science, Marketed Products Development
Found in: Lensa US 4 C2 - 3 days ago
Takeda Pharmaceutical Company Ltd Cambridge, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
-
Senior Medical Director, Clinical Science, Marketed Products Development
Found in: Lensa US 4 C2 - 3 days ago
Workday Cambridge, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that · the information I provide in my application will be processed in line with · Takeda's · Privacy Notice · and · Terms of Use . · I further attest that all ...
Director/Sr. Director, Clinical Science - Boston, MA, United States - Scorpion Therapeutics
Description
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 clinical trials in accordance with approved clinical development plans and Health Authority (e.g., FDA/EMA, etc.) regulatory requirements.
Key Responsibilities
Professional Experience/Qualifications