Associate Director/Director Clinical Sciences

4 weeks ago


Hampton, 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.



  • Hampton, United States Celldex Full time

    Celldex Therapeutics, Inc Associate Director/Director Clinical Sciences Hampton , New Jersey Apply Now 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...


  • Hampton, United States Celldex Therapeutics Full time

    Overview Long term interest in New Product Planning? Join a high growth clinical-stage biotechnology company focused on the development of immunotherapies for the treatment of inflammatory diseases and cancer. Lead market research and analytics projects, uncover insights, and shape the direction of the company. Join us at a critical time as we enter into...

  • Director of Nursing

    4 weeks ago


    Hampton Cove, United States Brookdale Senior Living Full time

    Director of Nursing Overview Health & Wellness Director (DON) -Brookdale Hampton Cove is a stand alone Memory Care community in Huntsville, AL. We are seeking a passionate & compassionate clinical leader to be our trusted care support for residents, families and staff. The qualified candidate must have prior leadership experience within a Long Term Care...


  • Hampton, New Jersey, United States Celldex Full time

    OverviewLong term interest in New Product Planning? Join a high growth clinical-stage biotechnology company focused on the development of immunotherapies for the treatment of inflammatory diseases and cancer. Lead market research and analytics projects, uncover insights, and shape the direction of the company. Join us at a critical time as we enter into...


  • Hampton, Virginia, United States Celldex Therapeutics Full time

    OverviewLong term interest in New Product Planning? Join a high growth clinical-stage biotechnology company focused on the development of immunotherapies for the treatment of inflammatory diseases and cancer. Lead market research and analytics projects, uncover insights, and shape the direction of the company. Join us at a critical time as we enter into...


  • Hampton, New Jersey, United States Celldex Therapeutics Full time

    OverviewLong term interest in New Product Planning? Join a high growth clinical-stage biotechnology company focused on the development of immunotherapies for the treatment of inflammatory diseases and cancer. Lead market research and analytics projects, uncover insights, and shape the direction of the company. Join us at a critical time as we enter into...


  • Hampton, United States Restart Services Full time

    Job DescriptionJob Descriptionb Title: Program Director/QMHP Job Category: Human ServicesLocation: Hampton Roads Travel Required: Community-BasedReports to: Executive Director Position Type: Full- TimeDESCRIPTION: The Program Director will be directly supervised by the Director and shall provide direct clinical supervision to all Day Treatment Clinicians and...

  • Foodservice Director

    4 weeks ago


    Hampton, United States Gecko Hospitality Full time

    Foodservice Director Location: Hampton, VA Salary: Up to $115 K plus benefits We have an exciting opportunity for a Foodservice Director in the Hampton, VA area. This is your chance to elevate your career with a national contract foodservice company. Director, Food, Hospitality, Restaurant, Staffing

  • area director

    2 weeks ago


    Hampton, Virginia, United States Gecko Hospitality Full time

    Area Director of Restaurant Operations Hampton Chesapeake, Virginia market. We operate in the full service segment, nationwide and have an immediate opening for a multi-unit manager Area Director position. Our brand is built on the highest qualit Director, Operations, Restaurant, Operation, Hospitality, Manufacturing, Staffing


  • Hampton, Virginia, United States ChenMed Full time

    We're unique. You should be, too.We're changing lives every day. For both our patients and our team members. Are you innovative and entrepreneurial minded? Is your work ethic and ambition off the charts? Do you inspire others with your kindness and joy?We're different than most primary care providers. We're rapidly expanding and we need great people to join...


  • East Hampton, United States The Retreat Full time

    What's the difference between a job and a rewarding profession? One is simply a means to an end; the other provides meaningful work with a sense of purpose and belonging. At The Retreat, we believe the work we do is meaningful and rewarding. We are committed to ending intimate partner violence in our community by providing no-fee counseling, legal services,...


  • Hampton, United States Gecko Hospitality Full time

    Director of Foodservice Operations Base salary up to $110KFull benefitsFive-day work week.  We are seeking a Director Of Food Services to join our team! You will be responsible for providing customers with a memorable dining experience. This is an excellent opportunity for someone with a strong contract foodservice background to assume a senior role...


  • East Hampton, United States The Retreat Full time

    Job DescriptionJob DescriptionWhat's the difference between a job and a rewarding profession?One is simply a means to an end; the other provides meaningful work with a sense of purpose and belonging.At The Retreat, we believe the work we do is meaningful and rewarding. We are committed to ending intimate partner violence in our community by providing...

  • Director of Quality

    4 weeks ago


    Hampton, United States Howmet Aerospace Full time

    Responsibilities Howmet Engine Systems (HES) seeks a highly qualified Director of Quality. They will be responsible for all aspects of Quality for multiple manufacturing facilities, including systems (Management System) and results (delivered quality measured in ppm and financial impact) through ensuring appropriate and functioning system of checks and...

  • Director of Quality

    4 weeks ago


    Hampton, United States Howmet Aerospace Full time

    Responsibilities Howmet Engine Systems (HES) seeks a highly qualified Director of Quality. They will be responsible for all aspects of Quality for multiple manufacturing facilities, including systems (Management System) and results (delivered quality measured in ppm and financial impact) through ensuring appropriate and functioning system of checks and...


  • Hampton, United States Hampton University Full time

    **Hampton University Staff**: The Assistant Director of Compliance is responsible for assisting with the implementation and management of a comprehensive athletics compliance program including enforcement of policies and procedures to ensure compliance with applicable NCAA, Colonial Athletic Association and Hampton University rules and...

  • Food Service Director

    4 weeks ago


    Hampton, United States Gecko Hospitality Full time

    Food Service Director Hampton, Va. Monday- Friday! Full Benefits Salary Range $100 k Bonus Opportunity The Food Service Director will serve as the companys representative and direct all dining service operations. The Food Service Director will work Food Service, Director, Service, Operations, Food, Restaurant, Staffing


  • Hampton, United States Gecko Hospitality Full time

    Foodservice Director Wanted: Contract Foodservice Expertise - Norfolk, Hampton, or Chesapeake, Virginia Are you an experienced Foodservice Director with a passion for delivering exceptional contract foodservice? We're looking for a dedicated professi Director, Food Service, Food, Client Relations, Operations, Restaurant, Staffing

  • Aquatics Director

    2 weeks ago


    Hampton, Virginia, United States Eastern Sports Management Full time

    The Hampton Aquaplex is accepting applications for Aquatics Director. The Aquatics Director is responsible for the overall direction, coordination, and supervision of the Aquatics Department. Under the direction of the General Manager, the Aquatics Director is responsible for creating community recreational aquatics opportunities for the general public,...

  • Music Director

    4 weeks ago


    Hampton, United States Ladgov Corporation Full time

    Job DescriptionJob DescriptionJob Title: Music DirectorLocation: Langley, VATravel: N/A Duties: The applicant shall perform for all regularly scheduled Gospel Services, choir rehearsals, and special services as determined by the Wing Chaplain. The applicant shall coordinate with other service music directors, musicians, and chaplains as necessary.The...