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Become A Clinical Research Director

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Working As A Clinical Research Director

  • Getting Information
  • Establishing and Maintaining Interpersonal Relationships
  • Making Decisions and Solving Problems
  • Organizing, Planning, and Prioritizing Work
  • Updating and Using Relevant Knowledge
  • Mostly Sitting

  • $120,160

    Average Salary

What Does A Clinical Research Director Do At Sanofi Group

* Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project
* Ensures clinical data meets all necessary regulatory standards
* Supports registrations, label submissions and modifications
* Participates in Advisory Committee preparation
* Scientific data dissemination:
* Ensures timely submission and dissemination of clinical data
* Supports the planning of advisory board meetings
* Establishes and maintains appropriate collaborations with knowledge experts
* In addition to the above activities the CRD must ensure that all activities of the GPT are conducted in compliance with current regulations, laws and guidance from FDA, EMeA, and CHMP, as well as with Sanofi’s policies and procedures

What Does A Clinical Research Director Do At Fred Hutchinson Cancer Research Center

* Work directly with the Consortium Director to inform clinical research strategic goals and ensure that the Consortium’s clinical research infrastructure is aligned to support these goals.
* Provide leadership to promote central oversight of study teams and help identify models that provide efficient division of responsibilities between CRS and study teams.
* Work closely with CRS administrative Director to ensure that CRS meets the NCI requirements of the Clinical Protocol and Data Management (CPDM) functions; in collaboration with Consortium partners, ensure that the overall Consortium clinical research infrastructure meets the NCI expectations of a Comprehensive Cancer Center.
* Serve as primary point-of-contact for faculty communications regarding CRS and Consortium clinical research infrastructure; work closely with Research Group Directors to stay abreast of clinical research-related issues as they arise.
* Escalate compliance issues and corrective and preventative action plans to PIs, leadership and the Clinical Research Oversight Committee (CROC) as appropriate; serve as faculty representative on the Compliance Sub-committee.
* Advise CRS Quality and Compliance on new policies and processes; provide interpretive support of new federal, state and local regulations.
* Represent faculty interests on Consortium improvement efforts and communicate potential impacts back to faculty.
* Ensure Consortium is compliant with ClinicalTrials.gov result reporting; ensure that sufficient resources are available to faculty.
* Provide direction and oversight to CRS-led faculty trainings.
* Collaborate with faculty and administrative leadership across Consortium partner institutions to ensure alignment of resources and priorities where appropriate, including:
* Serving as faculty advisor to the UW’s Institute of Translational Health Sciences, a Clinical and Translational Science Award (CTSA) Program;
* Liaising with Seattle Children’s oncology programs to ensure efficient integration with CRS and other Consortium functions;
* Advocating research integration into the clinical sites of practice across the Consortium including the UW and SCCA; and
* Working with the SCCA’s Network Research Office Medical Director to vet new Network sites and physicians for clinical trial participation

What Does A Clinical Research Director Do At Sanofi Group

* The CRD is a principal team member within the development group. (S)he provides medical and scientific leadership in the development of new therapies.
* The CRD is responsible for the medical aspects of the Global Clinical Development Plan (GCDP) and is accountable for the appropriate design, execution, and analyses of clinical trials within the GCDP. (S)he will work with a team composed of clinical development experts, statisticians, clinical operations personnel, medical writers, safety experts, regulatory affairs and external thought leaders to elaborate the best studies to show safety and efficacy, ultimately to obtain approval around the globe.
* S)he will become an expert in the disease and experimental therapy for which he/she is responsible.
* This expertise should be developed and maintained through background medical education, proficiency in current scientific literature, attendance and participation in scientific conferences and relationships with external experts. (S)he will maintain up to date knowledge of practices and scientific literature in the therapeutic area and communicate developments to appropriate internal staff.
* S(he) will act as an internal consultant/expert working closely with Medical Affairs, Business Development, Regulatory and Science organizations and may perform medical due diligence for external opportunities. (S)he will also support training on the disease to various internal stakeholders and present at internal governance and other meetings as well as external scientific meetings.
* S)he will present at regulatory meetings in various geographies to support the agreed-upon plan, and oversee the Medical Monitors responsible for monitoring clinical trials. (S)he will assist in regulatory activities including:
* A.
* Development of a working knowledge of regulatory aspects of the drug approval process including drugs, biologics, devices, as applicable
* B.
* Development of the regulatory strategy for the product consistent with the GCDP (orphan designation, use of surrogate endpoints, fast track designation, number and types of clinical trials, etc)
* C.
* Contributions to regulatory documents (INDs, NDAs, BLA’sMAAs, IDEs.
* Annual reports) and other written communications to regulatory bodies
* D.
* Preparation and participation in meetings with FDA, EMA and other regulatory authorities
* The candidate will also contribute their medical expertise in drug development to other project teams.
* Specifically, s(he) will be a member of the team developing therapies using various technologies such as gene therapy, anti-sense oligonucleotides, enzyme replacement therapy, small molecules among other treatment modalities

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How To Become A Clinical Research Director

Natural sciences managers usually advance to management positions after years of employment as scientists. Natural sciences managers typically have a bachelor’s degree, master’s degree, or Ph.D. in a scientific discipline or a related field, such as engineering. Some managers may find it helpful to have an advanced management degree—for example, a Professional Science Master’s (PSM) degree, a Master of Business Administration (MBA), or a Master of Public Administration (MPA).

Education

Natural sciences managers typically begin their careers as scientists; therefore, most have a bachelor’s degree, master’s degree, or Ph.D. in a scientific discipline or a closely related field, such as engineering. Scientific and technical knowledge is essential for managers because they must be able to understand the work of their subordinates and provide technical assistance when needed. 

Natural sciences managers who are interested in acquiring postsecondary education in management should be able to find master’s degree or Ph.D. programs in a natural science that incorporate business management courses. A relatively new type of degree, called the Professional Science Master’s (PSM), blends advanced training in a particular science field with business skills, such as communications and program management, and policy. Those interested in acquiring general management skills may pursue a Master of Business Administration (MBA) or a Master of Public Administration (MPA). Some natural sciences managers will have studied psychology or some other management-related field to enter this occupation.

Sciences managers must continually upgrade their knowledge because of the rapid growth of scientific developments.

Work Experience in a Related Occupation

Natural sciences managers usually advance to management positions after years of employment as scientists. While employed as scientists, they typically are given more responsibility and independence in their work as they gain experience. Eventually, they may lead research teams and have control over the direction and content of projects before being promoted to an administrative position.

Licenses, Certifications, and Registrations

Although certification is not typically required to become a natural sciences manager, many relevant certifications are available. These certifications range from those related to specific scientific areas of study or practice, such as laboratory animal management, to general management topics, such as project management, and are useful to natural sciences managers regardless of the organization being managed.

Important Qualities

Communication skills. Natural sciences managers must be able to communicate clearly to a variety of audiences, such as scientists, policymakers, and the public. Both written and oral communication are important.

Critical-thinking skills. Natural sciences managers must carefully evaluate the work of others. They must determine if their staff’s methods and results are based on sound science.

Interpersonal skills. Natural sciences managers lead research teams and therefore need to work well with others in order to reach common goals. Managers routinely deal with conflict, which they must be able to turn into positive outcomes for their organization.

Leadership skills. Natural sciences managers must be able to organize, direct, and motivate others. They need to identify the strengths and weaknesses of their workers and create an environment in which the workers can succeed.

Problem-solving skills. Natural sciences managers use scientific observation and analysis to find solutions to complex technical questions.

Time-management skills. Natural sciences managers must be able to do multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule.

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Clinical Research Director jobs

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Real Clinical Research Director Salaries

Job Title Company Location Start Date Salary
Clinical Research Medical Director Amgen Inc. Thousand Oaks, CA Sep 21, 2016 $250,016
Clinical Research Director, Global Oncology Sanofi-Aventis U.S. Inc. Cambridge, MA Mar 05, 2012 $215,000
Clinical Research Director, Global Oncology Sanofi-Aventis Us Inc. Cambridge, MA May 28, 2012 $215,000
SR. Clinical Scientist & Clinical Research Director Amgen Inc. Thousand Oaks, CA Aug 02, 2016 $212,000
VST Assoc Clinical Research Info Ofcr & DIR for BI University of Illinois at Chicago Chicago, IL Sep 26, 2011 $185,000
Clinical Research Director Medtronic, Inc. Santa Rosa, CA Sep 30, 2010 $184,320
Clinical Research Director West Coast Clinical Trials, LLC Cypress, CA May 17, 2012 $183,352

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Top Skills for A Clinical Research Director

ClinicalTrialParticipationRegulatoryDocumentsProceduresIRBFDACROOversightGCPVendorManagementResearchStaffBusinessDevelopmentLaboratoryCRAICHPharmaceuticalCompaniesDiabetesPhaseII-IVAdministrativeTrialManagementAccountabilitySampleP

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Top Clinical Research Director Skills

  1. Clinical Trial Participation
  2. Regulatory Documents
  3. Procedures
You can check out examples of real life uses of top skills on resumes here:
  • Interviewed and screened patients for clinical trial participation.
  • Handled Source Documents, Regulatory Documents, and case report forms.
  • Revised policies and procedures to ensure regulatory compliance and incorporate research compliance standards in research sites and facilities.
  • Communicated, submitted and executed IRB documents and requirements.
  • Direct contact with FDA to resolve any questions with BLA submission, limited to Clinical Study Report

Top Clinical Research Director Employers