Clinical Research Associate Director
4 weeks ago
We are seeking an Associate Director, Clinical Research Scientist to join our team at Deciphera Pharmaceuticals. As a key member of our clinical development team, you will be responsible for managing multidisciplinary drug development projects and ensuring that clinical and scientific issues are appropriately considered in the development and execution of individual clinical studies and overall development plans.
Key Responsibilities:- Work closely with Medical Directors, Pharmacology, Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols
- Assist Medical Directors in creation of proposed concept sheets for clinical studies and may write protocols or work with medical writing to write protocols through incorporation of input from both internal and external experts
- Drive the clinical contribution to annual update of IB liaising with Toxicology, Pharmacology, Safety, Regulatory and Medical & Communication Experts
- Drive and integrate clinical contribution to answering regulatory queries and other submissions related to studies
- Monitor real time study data to ensure the integrity of the study and the study data and interact with investigators and internal and external experts to resolve any study issues as they arise
- Involved in high level data cleaning activities requiring clinical judgment
- Involved in analysis of complex data for regulatory submissions, publications and design of studies and programs
- Act as clinical/scientific expert on the products and studies in the therapy area
- Attend scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators, and advisors
- Work with investigative sites to answer protocol related questions, resolve study conduct and design issues
- May present data, protocol designs and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
- Advanced degree in Life Sciences (or BS plus equivalent experience); Pharm D, or BSN or other equivalent clinical qualifications
- At least 5 years' experience in product & clinical development in Biotech or Pharmaceutical company
- Understanding of GCP, ICH and regional/local regulations
- Experience in both early and late phase development
- Medical knowledge and experience in clinical development/ operations (Oncology preferred)
- Experience reviewing clinical data outputs
- Ability to perform literature searches and to utilize library services
- Ability to conduct basic data analyses using Excel and other tools
- Basic understanding of biostatistics to allow effective interaction with biostatistics expert
- May require approximately 15-30% travel
- Teaching capability
- Excellent communication skills, both verbal and in writing
- Strong presentation skills
- Team player
- Ability to proactively predict issues and solve problems
- Ability to drive decision-making within a multi-disciplinary, multi-regional matrix team
- Diplomacy and positive influencing abilities
- Experience building data presentation plans
-
Clinical Research Director
4 weeks ago
Watertown, Massachusetts, United States Dragonfly Therapeutics, Inc. Full timeJob Title: Director, Clinical Research ScientistDragonfly Therapeutics is seeking a highly skilled Clinical Research Scientist to lead the implementation, planning, and execution of clinical trial activities. As a key member of our clinical development team, you will be responsible for delivering high-quality trial execution, investigator engagement, data...
-
Clinical Operations Director
4 weeks ago
Watertown, Massachusetts, United States Management Business Solutions Full timeClinical Operations Director Job SummaryManagement Business Solutions is seeking a highly experienced Clinical Operations Director to lead our clinical development programs. The ideal candidate will have a strong background in clinical operations, with expertise in global regulatory and compliance requirements for clinical research.Key...
-
Clinical Research Scientist
3 weeks ago
Watertown, Massachusetts, United States Dragonfly Therapeutics, Inc. Full timeJob SummaryDragonfly Therapeutics is seeking a highly skilled Clinical Research Scientist to lead the implementation, planning, and execution of assigned clinical trial activities. This role will report to the Head of Clinical Science and be responsible for delivering high-quality trial execution, investigator engagement, data review, safety assessment, and...
-
Director of Clinical Operations
3 weeks ago
Watertown, Massachusetts, United States Stratacuity Full timeJob Overview:The Director, Clinical Operations will lead the clinical trial operations for Stratacuity's immunology program across all phases, ensuring successful collaboration and team management.Lead clinical trial execution for a key immunology project, ensuring it meets deadlines, budget, and quality metrics.Manage project plans, including protocols,...
-
Associate Director of Biostatistics
4 weeks ago
Watertown, Massachusetts, United States C4 Therapeutics Inc Full timeAbout C4 TherapeuticsC4 Therapeutics is a clinical-stage biopharmaceutical company dedicated to harnessing the power of targeted protein degradation science to create innovative medicines that transform patients' lives. Our TORPEDO platform enables us to design and optimize small-molecule medicines to address difficult-to-treat diseases, offering the...
-
Oncology Asset Lead Director
4 weeks ago
Watertown, Massachusetts, United States HireMinds Full timeJob Title: Sr. Director, Oncology Asset LeadHireMinds is seeking an experienced Sr. Director, Oncology Asset Lead to drive the vision, strategy, and execution of drug development programs with a well-positioned biotech local to Boston.Key Responsibilities:Lead cross-functional teams to develop and execute comprehensive program strategies, incorporating...
-
Research Scientist
4 weeks ago
Watertown, Massachusetts, United States Apellis Full timeJob DescriptionWe are seeking a highly motivated and talented individual to join our research team at Apellis Innovation Laboratory in Watertown, MA. The successful candidate will be part of the Non-Clinical Development bioanalytical group, contributing to the discovery of novel treatments for ocular and neurologic diseases by targeting the complement...
-
Marketing Director
3 weeks ago
Watertown, Massachusetts, United States Cambridge Network Full timeJob Title: Director, MarketingReports To: VP of Business DevelopmentDivision: MarketingDepartment:Program Operations Location: RemoteFLSA Status: FT Benefited positionPosition Overview: This role is responsible for the strategic planning and execution of all US marketing efforts, including creating long-term content strategies, social media strategies,...
-
Marketing Director
4 weeks ago
Watertown, Massachusetts, United States Cambridge Network Full timeJob Title: Director, MarketingReports To: VP of Business DevelopmentDivision: MarketingDepartment:Program Operations Location: RemoteFLSA Status: FT Benefited positionPosition Overview: This role is responsible for developing and executing the strategic marketing plan for the US market, including creating a long-term content strategy, social media strategy,...
-
Resource Development Associate
3 weeks ago
Watertown, Massachusetts, United States Sadoway Labs Foundation Full timeSadoway Labs Foundation is a nonprofit organization dedicated to discovering solutions for deployable technologies that can help reduce global carbon dependence. Our mission is to accelerate the development of extreme electrochemistry technologies through research, innovation, collaboration, and education.We are seeking a part-time Resource Development...
-
Resource Development Associate
4 weeks ago
Watertown, Massachusetts, United States Sadoway Labs Foundation Full timeResource Development AssociateSadoway Labs Foundation is a nonprofit organization dedicated to discovering solutions for deployable technologies that can help reduce global carbon dependence. We are seeking a part-time Resource Development Associate to join our team and help us achieve our mission.Key Responsibilities:Research and identify potential...
-
Director of Contract Negotiations
4 weeks ago
Watertown, Massachusetts, United States Dyne Therapeutics Inc Full timeJob Title: Director, Contracts CounselAt Dyne Therapeutics Inc, we are seeking a highly skilled and experienced Director, Contracts Counsel to join our team. This is a full-time position based in Waltham, MA.Job Summary:The Director, Contracts Counsel will be responsible for managing a wide range of contract negotiations and agreements to support our...
-
Watertown, Massachusetts, United States AbbVie Full timeJob DescriptionAbbVie is seeking a highly motivated individual to join our team as an Associate Director, Companion Diagnostics Strategy within the Precision Medicine Companion Diagnostics team. The successful candidate will have the opportunity to work in a highly collaborative environment and will be a key member of multidisciplinary development project...
-
Senior Toxicology Researcher
3 weeks ago
Watertown, Massachusetts, United States Stratacuity Full timeJob Title: Senior Toxicology ResearcherJob Summary: We are seeking a highly skilled Senior Toxicology Researcher to join our team at Stratacuity. As a key member of our team, you will be responsible for evaluating preclinical safety and assisting in drug development from discovery to clinical trials.Key Responsibilities:Supervise toxicology research at...
-
Senior Translational Research Scientist
4 weeks ago
Watertown, Massachusetts, United States Apellis Full timeJob SummaryThe Senior Translational Research Scientist will be responsible for developing cross-functional program-level strategies to identify novel fluid, digital, imaging, and/or technology-related endpoints for use in preclinical and early-stage clinical neurology programs. This role will entail demonstrating proof of concept for potential endpoints in...
-
Livestock Research Assistant
3 weeks ago
Watertown, Massachusetts, United States Alta Genetics Full timeJob OverviewAs a Livestock Research Assistant at Alta Genetics, you will play a key role in optimizing current livestock handling and semen collection practices. This hands-on experience will include activities associated with the daily care of bulls, compiling research data, and presenting findings to company leadership.Key Responsibilities Perform daily...
-
Behavioral Health Nursing Director
3 weeks ago
Watertown, Massachusetts, United States Boston Children's Hospital Full timeJob Title: Behavioral Health Nursing DirectorBoston Children's Hospital is seeking a highly skilled and experienced Behavioral Health Nursing Director to lead our Behavioral Health programs. The successful candidate will be responsible for providing 24-hour supervision of patient care operations, planning and organizing daily clinical services and...
-
Ocular Research Specialist
4 weeks ago
Watertown, Massachusetts, United States Talent Groups Full timeKey Responsibilities:Education and Experience: PhD or Master's degree in Ophthalmology or a related field, with extensive experience in ocular research.Vivarium Responsibilities: Proven experience in non-clinical ocular imaging, animal handling, intravitreal injections, eye dissection, and tissue perfusion.Sample Management: Hands-on experience managing...
-
Regional Director
1 month ago
Watertown, Massachusetts, United States Proclinical Staffing Full timeRegional Director - MSLs Job DescriptionProclinical Staffing is seeking a highly skilled Regional Director to lead a team of Medical Science Liaisons (MSLs) for an established biotech company.Key Responsibilities:Lead and manage a team of MSLs to deliver high-quality scientific support to healthcare professionals.Develop and implement strategic plans for the...
-
Clinical Diagnostic Operations Manager
4 weeks ago
Watertown, Massachusetts, United States AbbVie Full timeAbout the RoleAbsorb the opportunity to lead the implementation of clinical diagnostic strategies for therapeutic programs in early and late stage oncology clinical development at AbbVie.This role requires a highly motivated individual to work closely with CDx Strategy Leads and other clinical development team members to facilitate science-based CDx decision...