Clinical Research Director jobs in Trenton, NJ

Clinical Research Director directs and oversees the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Clinical Research Director ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Requires an advanced degree. Additionally, Clinical Research Director typically reports to top management. The Clinical Research Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Clinical Research Director typically requires 5+ years of managerial experience. (Copyright 2024 Salary.com)

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Executive Director Clinical Research
  • AMICUS
  • Princeton, NJ FULL_TIME
  • Executive Director Clinical Research

    Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

     

    Position Summary

    The Executive Director Clinical Research will be responsible for all phases of Clinical Development from the continued development of marketed product(s) as well as assets in early development. The incumbent will be responsible for leading the generation of the clinical development plans and the clinical trial protocols that will lead to successful submissions of novel treatments. This individual may also have significant early-on interaction with clinical/preclinical teams and will collaborate with other functions in the Development Organization and across Amicus Therapeutics to optimize the strategy and to plan, implement, execute, analyze and report the clinical studies, culminating in global regulatory submissions.

     

    Roles and Responsibilities

    1.           Lead the clinical development strategy and the Clinical Development Plan (“CDP”) preparation for clinical programs and clinical trial protocols.

    2.           Responsible for assets from early phase through to registration and the approval process.

    3.           Play a significant leadership role with the potential to oversee junior member(s) of the clinical team, as well as providing hands on tactical work, in project teams and working in collaboration with relevant team members and peers, to ensure the highest level of execution for clinical programs.

    4.           Work with Clinical Trial Investigators and Clinical Research Organizations to collaborate on trial site selection, training and ongoing conduct of the study.

    5.           Ensure that studies are performed with the highest quality. Perform data review and analysis, presentations (oral and written) of clinical data, and lead the generation of clinical study reports.

    6.           Successfully interact with experts and other external partners in a manner consistent with Amicus’ beliefs.

    7.           Participate in preparation of regulatory documents (e.g. Investigator Brochures, CSRs, Briefing documents) and in face-to-face meetings with the regulatory agencies.

    8.           Maintain highest level of medical science and clinical development expertise in Amicus’ fields of interest.

    9.           Collaborate on business development activities

    10.        Perform all responsibilities in compliance with company policies, SOP and guidelines.

    11.        Share, within the Development Organization and the Company, his/her knowledge and expertise in drug development to broaden and update the current level of awareness and practice in the field.

     

    Requirements

    Educational Requirements

                M.D. degree. Post residency training is preferred.

    Professional Work Experience Requirements

                A minimum of 8 years’ industry experience is preferable, though consideration will be given to exceptional candidates with less time in industry.

     

    Experience and Skills

                Completion of a residency, preferably in either pediatrics or internal medicine and, ideally, a fellowship in a related subspecialties area (e.g., neurology, gastroenterology, genetics, immunology, etc).

                A drug development professional with experience derived from a career in a major pharmaceutical company, or in a biotechnology or biopharmaceutical company environment, including, preferably, a key role in the submission of successful NDA/BLAs and/or MAAs. The ideal candidate will have experience spanning the phases of drug development, preferably from proof- of concept studies to medical affairs.

                Experience with rare and orphan diseases or knowledge of lysosomal storage disorders is not requisite, but is a plus.

                Experience on teams with early and late stage development products.

                Desire and ability to work in a fast-paced, mission-driven environment.

                Strong project management skills; the ability to oversee multiple, complex programs.

                Flexibility and adaptability; ability to thrive successfully in a small biotechnology company environment.

                Excellent oral and written communication skills.

                Clear alignment with Amicus values and culture. Strong interpersonal skills, a collaborative team player who is open minded to the diverse opinions of others.

                Clear alignment with Amicus values and culture.

                Ability to produce highest quality and timely clinical development work product/ documents with limited direction.

                Hands-on performer, ensuring strong execution of clinical trials and other drug development activities.

                A strong sense of personal and professional ethics.

                A good balance of confidence and humility.

                Must be passionate about developing treatments for patients with rare/orphan diseases.

    Other skills/Attributes

                Demonstrated alignment with Amicus Mission Focus Behaviors

                Passion for rare disease and patient focused

    Travel

                Ability to travel, both domestic and international (± 25%).

    Location

                Preferred location is Princeton, NJ (with a hybrid work approach)

     

    We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.  Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence.  Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

    Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.

     

    #LI-HYBRID

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  • 10 Days Ago

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Director Clinical Research
  • System One
  • Princeton, NJ OTHER
  • Title: Director of Clinical Research Location: Must be local Princeton, NJ Type: Perm Start Date: ASAP Leading Pharmaceutical Company located in NJ is hiring a Director of Clinical Research w/ 10 year...
  • Just Posted

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Associate Director, Patient Centered Research & Clinical Outcome Assessments
  • Otsuka Pharmaceuticals, Inc
  • Princeton, NJ FULL_TIME
  • Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures...
  • 8 Days Ago

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Lead Clinical Research Associate
  • Actalent
  • Pennington, NJ FULL_TIME
  • Description:Lead CRACRA oversight- tracking metrics of 5-7 CRAsVendor OversightResponsible for 2 sites independently as well as oversight Location: Mountain timeThe candidate will be primarily respons...
  • 6 Days Ago

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Clinical Research Associate
  • Katalyst Healthcares & Life Sciences
  • Plainsboro, NJ FULL_TIME
  • Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have ...
  • 14 Days Ago

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Research Director, Qualitative Market Research
  • Omnicom Health Group
  • Doylestown, PA OTHER
  • Overview Title: Research Director, Qualitative Market Research Location: The Planning Shop - Remote in New York/New Jersey/Pennsylvania Department/Discipline: Research Are you ready for a new challeng...
  • Just Posted

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0 Clinical Research Director jobs found in Trenton, NJ area

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Director Clinical Development
  • Green Key Resources
  • Princeton, NJ
  • Must be available to come onsite 2x a week Responsibilities: • Provide scientific and clinical expertise to support the ...
  • 3/28/2024 12:00:00 AM

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IDN Key Account Director, Midwest Region - Sintetica US
  • Sintetica US
  • Princeton, NJ
  • IDN Key Account Director, Midwest Region Sintetica US Sintetica US, Princeton, New Jersey, On site or Remote Full-time M...
  • 3/28/2024 12:00:00 AM

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IDN Key Account Director, Northeast Region - Sintetica US
  • Sintetica US
  • Princeton, NJ
  • IDN Key Account Director, Northeast Region Sintetica US Sintetica US, Princeton, New Jersey, On site or Remote Full-time...
  • 3/28/2024 12:00:00 AM

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Associate Sales Representative - Patient Resuscitation & Treatment
  • Strykermeded
  • Trenton, NJ
  • **Associate Sales Representative Patient Resuscitation & Treatment** **Remote** **COVID-19 vaccination requirements** St...
  • 3/28/2024 12:00:00 AM

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Director, Oncology Medical Engagement Lead (MD required) - REMOTE
  • Bristol Myers Squibb
  • Lawrence Township, NJ
  • **Working with Us** Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. Bu...
  • 3/27/2024 12:00:00 AM

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Director, Dermatology Medical Engagement Lead (MD required) - REMOTE
  • Bristol Myers Squibb
  • Lawrence Township, NJ
  • **Working with Us** Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. Bu...
  • 3/26/2024 12:00:00 AM

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Director, Specialty Clinical Solutions- REMOTE
  • Careerbuilder
  • Trenton, NJ
  • Prime Therapeutics Director, Specialty Clinical Solutions- REMOTE Trenton , New Jersey Apply Now Our work matters. We he...
  • 3/25/2024 12:00:00 AM

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Senior Director, Immunology TA
  • CSL Behring
  • King of Prussia, PA
  • CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around t...
  • 2/28/2024 12:00:00 AM

According to the United States Census Bureau, the city had a total area of 8.155 square miles (21.122 km2), including 7.648 square miles (19.809 km2) of land and 0.507 square mile (1.313 km2) of water (6.21%). Several bridges across the Delaware River – the Trenton–Morrisville Toll Bridge, Lower Trenton Bridge and Calhoun Street Bridge – connect Trenton to Morrisville, Pennsylvania, all of which are operated by the Delaware River Joint Toll Bridge Commission. Trenton is located near the exact geographic center of the state, which is 5 miles (8.0 km) located southeast of Trenton. The city is so...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Director jobs
$155,430 to $209,828
Trenton, New Jersey area prices
were up 1.5% from a year ago

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Clinical Research Director in Springfield, IL
During the Clinical Research Operations Forum a few weeks ago, Stephen Sonstein, Ph.D., Professor & Program Director for Clinical Research Administration at Eastern Michigan University spoke on the shift in clinical research going from a focus on regulatory compliance to a standardization of competencies for professionals working in the field.
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Clinical Research Director in Olympia, WA
You might occasionally be able to enter from the administration side - for example, you could start as a study-site coordinator in the NHS or as a clinical trials administrator.
January 28, 2020