CCRA (Certified Clinical Research Associate), CCRC (Certified Clinical Research Coordinator), CPI (Certified Principal Investigator), CCRP (Certified Clinical Research Professional), CIP (Certified IRB Professional), RAC (Regulatory Affairs Certification)
Academic / Research
The Clinical Scientist / Senior Clinical Scientist will support Celldex’s clinical development programs by contributing to the design of development plans and clinical protocols, review and evaluation of clinical data, and reporting of clinical studies in a manner consistent with industry standards, applicable regulations and clinical development strategy. This position will be based in either Needham, MA or Hampton, NJ.
Author clinical documents including but not limited to: clinical protocols, Investigator's Brochures, briefing documents and other regulatory filings, IND annual reports, clinical study reports, product-specific safety language, manuscripts, abstracts and presentations.
Working with the medical director, develop clinical strategy (perform literature review/analysis, solicit/coordinate input from medical, statistical and operational resources).
Working with the study team, ensure quality and interpretability of clinical data consistent with program objectives (i.e., provide input to CRF design, data review/collection plans, statistical analysis plans and data displays).
Evaluate and investigate emerging clinical data; monitor events relating to protocol conduct rules; working with biostatistics, compile data to facilitate program-level decisions and/or abstracts, presentations and manuscripts.
Participate in planning for interim/final data analyses and periodic data reviews, including Data Safety Monitoring Board (DSMB) and Safety Review Team meetings.
Serve as resource for study team regarding interpretation and compliance to protocol; review study-specific documentation (informed consent forms, procedure manuals, etc.) to ensure protocol adherence.
Ability to develop collaborative working relationships with project teams, physicians, expert consultants, and contracted vendors.
Strong analytical mind, excellent written/verbal communication skills, attention to detail, organizational skills, and ability to work independently and as part of a team.
Strong document management skills.
BA/BS degree or equivalent in a scientific or health care field required.
At least 5 years of experience in clinical development, including medical writing responsibilities and close collaboration with operational staff including data management, biostatistics, and regulatory functions.
Celldex Therapeutics recruits highly motivated and talented people in order to build a strong and diverse workforce, which is working to develop targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline of drug candidates is comprised of therapeutic antibodies, antibody drug conjugates, immune system modulators and vaccines that we believe ha...ve a higher probability of success because they are targeted to specific patient populations with high unmet medical need whose diseases express specific markers. This has created a leading pipeline in immunotherapy with seven company-led clinical trials across five product candidates, including a pivotal study in triple negative breast cancer and six Phase 1 and Phase 2 cancer immunotherapy combination trials in a range of difficult-to-treat indications, and a robust preclinical engine.