ASSOCIATE DIRECTOR/DIRECTOR CLINICAL SCIENCES

2 weeks ago

MA United States Celldex Therapeutics Full time
Overview

Join 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

* 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.

Qualifications

* 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.

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

  • Outpatient Clinic Director- Cape

    5 days ago

    Hyannis, MA, United States Bay Cove Human Services Full time

    Bay Cove Human Services' mission is to partner with people to overcome challenges and realize personal potential. Bay Cove pursues this mission by providing individualized and compassionate services to people facing the challenges associated with developmental disabilities, mental illness, substance use disorders, and homelessness at more than 175 program...

  • Outpatient Clinic Director- Cape

    7 days ago

    Hyannis, MA, United States Bay Cove Human Services Full time

    Bay Cove Human Services' mission is to partner with people to overcome challenges and realize personal potential. Bay Cove pursues this mission by providing individualized and compassionate services to people facing the challenges associated with developmental disabilities, mental illness, substance use disorders, and homelessness at more than 175 program...

  • Outpatient Clinic Director- Cape

    2 weeks ago

    Barnstable, MA, United States Bay Cove Human Services Full time

    Bay Cove Human Services’ mission is to partner with people to overcome challenges and realize personal potential. Bay Cove pursues this mission by providing individualized and compassionate services to people facing the challenges associated with developmental disabilities, mental illness, substance use disorders, and homelessness at more than 175 program...

  • Associate Director for Women and Infants

    4 weeks ago

    Philadelphia, PA, United States Temple University Hospital Full time

    Associate Director for Women and InfantsAssociate Director for Women and Infants 40hrs Evening 3-11 -Temple Hospital Under the direction of the Director, Nursing, the Associate Director provides oversight of the nursing care provided to patients on a nursing unit. Maintains standards of service excellence and nursing practice. Develops evidenced based...

  • Project Director

    7 days ago

    Boston, MA, United States Mass General Brigham Full time

    DescriptionBipolar Disorder Learning Health Network Project DirectorJob Description:The Bipolar Disorder Learning Health Network’s (BD LHN) mission is to ensure that every person living with bipolar disorder is part of a system that reduces morbidity and improves the health and well-being of people with bipolar disorder. The Network will bring together a...

  • Director Clinical Pharmacology

    4 days ago

    Waltham, MA, United States AstraZeneca Full time

    Director Clinical Pharmacology & Pharmacometrics (Clinical Pharmacology)Introduction to role:Join us as a Director Clinical Pharmacology & Pharmacometrics, a scientific role that works closely with the clinical team to create a clinical pharmacology development program. This role provides differentiated medicine and the right dose to patients. You will apply...

  • Anesthesia Associate SRNA Program Director

    1 day ago

    Boston, MA, United States Partners Healthcare System Full time

    GENERAL OVERVIEW Assistant SRNA Program Director is responsible for the development, implementation and evaluation of the SRNA educational program. The Assistant SRNA Program Director provides clinical and didactic support to the School of Nurse Anesthesia student population (SRNA's). Assures the smooth day-to-day clinical responsibilities required by the...

  • Director Data Science

    1 week ago

    Marlborough, MA, 01752, Middlesex County, MA, United States BJ's Wholesale Club Full time

    Join our team of more than 34,000 team members, supporting our members and communities in our Club Support Center, 235+ clubs and eight distribution centers. BJ’s Wholesale Club offers a collaborative and inclusive environment where all team members can learn, grow and be their authentic selves. Together, we’re committed to providing outstanding service...

  • Outpatient Clinic Director- Cape

    1 week ago

    Barnstable, MA, United States Bay Cove Human Services Full time

    Bay Cove Human Services’ mission is to partner with people to overcome challenges and realize personal potential. Bay Cove pursues this mission by providing individualized and compassionate services to people facing the challenges associated with developmental disabilities, mental illness, substance use disorders, and homelessness at more than 175 program...

  • Clinical Director RN

    24 hours ago

    Houston, TX, United States The Pediatric Connection Full time

    Clinical Director RNDon't just work, thrive! Thrive SPC, a national provider of Pediatric Private Duty Nursing, is seeking an Area Clinical Director RN to join our team in Houston. We seek a dynamic Clinical Leader who is passionate about improving the lives of the children in the communities we serve. This person would serve as the clinical resource for...

  • Staff Dentist or Dental Director

    6 days ago

    Berkshire, MA, United States Specht & Associates Full time

    DENTAL DIRECTOR (DENTIST) - MA/DENTAL Dental Center Director (Dentist) 20% Administrative. Our client is a network of health centers and caring professionals that provide outstanding primary and preventive care for patients of all ages. What's truly unique to them is their broad spectrum of support services that extend beyond medical and dental issues...

  • Clinical Director

    4 weeks ago

    San Antonio, TX, United States CHRISTUS Health Full time

    Summary:Manages the nursing services and staff for a department; ensures quality and full compliance with relevant policies and standards.CHRISTUS Santa Rosa Hospital - Westover Hills (CSRH-WH) is a 150-bed hospital serving the fastest growing area of San Antonio. Specialized care includes orthopedic and surgical services, ICU, women’s services, a newborn...

  • Clinical Director

    1 week ago

    Cleveland, OH, United States Connections In Ohio Full time

    Connections in Ohio, Inc. is a growing company that has been providing community supports to individuals with intellectual and developmental disabilities in community settings, for over 26 years. We are seeking a highly organized problem solver for a great opportunity! We are hiring a Clinical Director to support our teams within the areas of all Clinical...

  • Director, Analytical Sciences

    2 weeks ago

    Lexington, MA, United States Kiniksa Pharmaceuticals Full time

    Reporting to the Senior Director, AS&QT, the Director, AS&QT will be responsible for managing the analytical sciences needs of Kiniksa’s pipeline, from discovery to commercial stages. In partiocularm, this position will be responsible for methods and products characterization and comparability. Technical collaboration and integrated planning with...

  • Clinical Director

    2 days ago

    Somerville, MA, United States Bay Cove Human Services Full time

    Bay Cove Human Services’ mission is to partner with people to overcome challenges and realize personal potential. Bay Cove pursues this mission by providing individualized and compassionate services to people facing the challenges associated with developmental disabilities, mental illness, substance use disorders, and homelessness at more than 175 program...

  • Director of Administration

    3 weeks ago

    Washington, DC, United States American Sugarbeet Growers Assn Full time

    Description: Manage a four-person office and support a professional team consisting of the CEO, VP Government Relations and VP of Science and Innovation, along with a 50-member Board of Directors. This position is in a small and very professional organization, with strong support by its farmer membership. The applicant will be replacing our retiring...

  • Surgical Technologist Clinical Director

    1 week ago

    Tucson, AZ, United States Pima Medical Institute Full time

    ESSENTIAL FUNCTIONSSecure new clinical sites and contractual agreements.Review student success rates by class and implement plan to reduce student withdrawals. Meet with students to encourage them to stay in the program. Maintain an 80% student success rate for all classes taught in the program.Monitor competency evaluations and clinical records with...

  • RN DIRECTOR SURGICAL OPERATIONS

    2 weeks ago

    Cocoa, FL, United States Clinical Management Consultants Full time

    Are you ready to lead the surgical services team of a prestigious hospital while living a charming coastal lifestyle? A renowned 150 bed hospital on the beautiful Canaveral Coast of Florida is seeking a dynamic and experienced RN Director Surgical Op Director, Operations, Surgical, RN, Nurse Manager, Operation, Healthcare, Staffing

  • Physician- Associate Program Director Internal Medicine

    4 weeks ago

    Riverdale, GA, United States Southern Regional Medical Center Full time

    With oversight and direction from the Program Director(s), the Assistant Program Director is responsible for the operational functions of the accredited GME training programs. The position requires a comprehensive and detailed understanding of the national accreditation policies and hospital policies, as well as a high degree of initiative and independent...

  • Physician Clinic Medical Director

    1 week ago

    Sarasota, FL, United States Concentra Full time

    Overview:Are you ready to take your career to new heights? At Concentra, you will be a vital member of our patient care team and play a crucial role in providing exceptional care to our patients. Our mission is to improve the health of America's workforce, one patient at a time. Join us at Concentra and see how your clinical competency and compassion can...