- Working with CMO, VP, Clinical Science and medical directors, contribute to the development of clinical protocols/amendments by performing literature review/analysis and soliciting input from medical, statistical and operational, as well as pre-clinical, resources.
- Ensure clinical data collection proceeds in a manner consistent with strategic objectives and regulatory requirements for reporting (i.e., collaborate with statisticians to produce statistical analysis plans and data displays; provide input to CRF design and data management processes; perform periodic review of clinical data).
- Participate in planning for interim data analyses and reviews, including Data Safety Monitoring Board (DSMB) meetings.
- Working with the medical director, monitor and evaluate emerging clinical data.
- Review/interpret data to produce strategically relevant abstracts, presentations and manuscripts.
- Author (and/or work with medical writer to develop) clinical documents including but not limited to: clinical protocols, briefing documents, IND annual reports, Investigator's Brochures, clinical protocols and amendments, clinical study reports, scientific manuscripts and abstracts, posters and scientific presentations.
- 5-10 years of experience in clinical research setting, including medical writing and oversight of (or close collaboration with) data management/analysis/reporting functions.
- MS/MA degree or equivalent in a scientific or health care field required. PhD's preferred.
- Experience authoring clinical protocols, regulatory documents (IND sections, clinical study reports, investigator brochures), as well as scientific publication and presentations.
- Ability to collaboratively develop relationships with physicians, expert consultants, and contracted vendors.
- At least 2 years of experience in immunology & inflammation preferred.
- 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, including proficiency with MS Office Suite.
- Strong medical writing skills: takes ownership of document, organizes timeline, works with other co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar
- Knowledge and experience in clinical development
- Ability to multitask to meet timelines under changing conditions.
-
Director, Clinical Science
2 days ago
Progenics Pharmaceutical Inc Bedford, United StatesJob Description · Job DescriptionLantheus 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 have helped physicians enhance patient care wi ...
-
Registered Nurse
5 days ago
Lower Bucks Hospital Bristol, United States**Overview**: · Join an award-winning team of dedicated professionals committed to our core values of quality, compassion and community Lower Bucks Hospital, a member of Prime Healthcare, offers incredible opportunities to expand your horizons and be part of a community dedicated ...
-
Associate Director/Director, Clinical Sciences
2 weeks ago
Stealth BioTherapeutics Massachusetts, United StatesIn this newly created position, the Associate Director/Director, Clinical Sciences will report to our Executive Director, Clinical Sciences with primary responsibility to further advance progress of our expanding ophthalmology program. In addition to planning, implementing, and m ...
-
Clinical Risk Specialist
4 days ago
Thundermist Health Center Warwick, United StatesThundermist's Mission - To improve the health of our patients and communities by delivering exceptional health care, removing barriers to that care, and advancing healthy lifestyles. · Please note, effective September 1,2021, all Thundermist employees are required to have an init ...
-
Midwife-ob-gyn
3 days ago
Southcoast Health System, Inc. New Bedford, United StatesOverview: · **Find out for yourself why Southcoast Health has been voted 'Best Place to Work' for 6 years in a row** · Join Southcoast Health, where your future is as promising as the care we provide. Our commitment to each other, our patients, and our community is more than a mi ...
-
Scheduler
1 week ago
VNA of Care New England Warwick, United States**Job Summary**: · Responsible for all patient schedules. In conjunction with the Clinical Managers coordinates, monitors, verifies, and accounts for all required patient admissions/visits. Checks all work for accuracy and completeness. Ensures a timely and effective flow of sche ...
-
Registered Nurse
3 days ago
The Edinburg Center Bedford, United States**Registered Nurse (RN)** · **Mental Health** · **Mobile position in the surrounding communities of Bedford, MA** · The Edinburg Center is seeking a Registered Nurse for our Program of Assertive Community Treatment (PACT) Services group. · If you feel burnt out and are looking fo ...
-
Steppingstone Inc. New Bedford, United States**SUMMARY**:The Director of Medication Assisted Treatment (MAT) works as an integral part of the Executive Team. The Director of MAT will perform, but is not limited to, the following duties: oversight of project, conduct supervision of assigned personnel, provide in-service trai ...
-
Clinical Laboratory Assistant
3 days ago
Rhode Island Hospital Providence, United StatesSummary: · The Clinical Lab Assistant reports to a senior tech or manager. Under general supervision and with appropriate training and documented competency can perform various complex laboratory testing in the assigned lab section. The CLA may have tasks in all phases of lab tes ...
-
Project Manager-cro
4 days ago
LOTUS CLINICAL RESEARCH LLC New Providence, United States**Job Title: Project Manager** · **Location: Remote** · The Project Manager is a proven leader in clinical program management in the clinical research industry, and manages, executes, and reports on clinical study operations. This position provides leadership and support to membe ...
-
Board Certified Behavior Analyst
3 days ago
Butterfly Effects Fall River, MA, United StatesThis is not just another place to work, Butterfly Effects is led by BCBAs with Dr. Steve Woolf, PhD., BCBA-D, as our President and Molly McGinnis, M.Ed., BCBA, as our Vice President of Clinical Services and Practice Development. We make every effort to ensure that you as the BCBA ...
-
Quality Assurance Technician Imrt
1 week ago
Rhode Island Hospital Providence, United States**Summary**: · Reports to the Associate Physicist in charge of QA and second year Physics Resident. · **Responsibilities**: · Performs clinical patient dosimetry to verify and assure that patient is receiving precisely the prescribed dose. · Measures radiation dose using an array ...
-
Research Assistant 24d
6 days ago
Women & Infants Hospital Providence, United States**Job Summary**: The research assistant performs duties related to research projects directed by MD's, PhD's and other professional staff members. Responsible for data collection, accurate recording, and other related duties in assisting study team. · **Specifications**: Nursing ...
-
Clinical Research Assistant Pd
1 day ago
Rhode Island Hospital Providence, United States**Summary**: · Under the general supervision of the Principal Investigator(s) and Clinical Research Coordinator assist in acquisition and analysis of patient information for multiple clinical research projects. Interviews patients to gather information prepares and maintains stud ...
-
Onsite Cybersecurity Analyst
1 week ago
Canopy Life Sciences LLC Bridgewater, United StatesL1 Cybersecurity Analyst · - Bridgewater, NJ (On-site) · - Full Time · Company Description · Headquartered in Danbury, CT, Canopy Life Sciences is an end-to-end Life Sciences partner to help speed sciences from pipeline to people. We provide clinical to commercial solutions to Li ...
-
Manager, Clinical Supplies
1 week ago
Ortho Dermatologics Bridgewater, United StatesBausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on ...
-
Clinical Trial Associate
4 days ago
Ortho Dermatologics Bridgewater, United StatesBausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on ...
-
Clinical Supplies Associate
1 week ago
Ortho Dermatologics Bridgewater, United StatesBausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on ...
-
Charge Nurse
1 day ago
Brockton Neighborhood Health Center Brockton, United States**Charge Nurse** · **$80,498 - $94,704.00** · **$5,000 Sign-on Bonus** · **REPORTS TO: Assistant Director of Nursing** · ***: · The Charge Nurse is responsible for the oversight of all nursing activities within a POD/ Clinical Team. Oversees all the nursing areas, ensures efficie ...
-
Phlebotomist Pd
1 day ago
The Miriam Hospital Providence, United States**Summary**: · Under supervision of the Manager Laboratory Outreach Services or guidance of the Lead Phlebotomist performs responsibilities associated with obtaining blood and various other patient specimens in accordance with department procedures. Obtains samples ordered by phy ...
Associate Director/Director Clinical Sciences - Fall River, United States - Celldex Therapeutics
Description
OverviewJoin a growing Clinical Science team where you will work directly with the VP, Clinical Science.
You will support Celldex's clinical development programs by contributing to the design, data collection, and reporting of clinical studies in a manner consistent with industry standards, applicable regulations and clinical development strategy.
This position assembles, interprets, and presents scientific and medical data. Responsibilities will also include evaluation of clinical outcome measures, data review and trial startup activities.Responsibilities
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion.
