Director of Clinical Affairs

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Sterling-Hoffman Executive Search Located in: North Carolina

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JOB DESCRIPTION

Partial Job Description

1) Coordinate/perform routine and specially assigned laboratory tasks in the laboratory, including product testing and data analysis

2) Ensure such information correctly conveyed into the appropriate documentation required to satisfy company?s quality standards and compliance commitments

3) Perform trending of data as needed and provide quality control representation at cross-functional meetings

4) Act as the Technical lead for method validations, project execution, and company initiatives

5) Provide clinical trial expertise in complex medical outcome studies in infectious disease and oncology that deliver results, thereby advancing the company?s market position and reputation for scientific and technological innovation

6) Be accountable for the preparation, conduct and monitoring of complex clinical trials at a global level and a key person in decision making within projects and programs and within the department

7) Lead development of complex clinical trials, including selecting and qualifying sites, reviewing and writing trial plans/protocols and reports, setting-up, equipping and training sites, as well as negotiating site contracts

8) Ensure compliance in conduct and monitoring clinical trials, coordinating all contact with the sites, problem solving, analyzing data, as well as building and maintaining relationships with investigators and the sites

9) Review status of trials in order to keep management informed

10) Make technical and strategic decisions about the progress of trials and problem-solving for teams

11) Serve as an expert in the field, participate in external industry groups

12) Generate publications and posters

13) Negotiate with authorities and participate on ethics boards

14) Ensure that procedures, protocols, training and reports developed in compliance with regulatory requirements and updated regularly

15) Ensure the development of teams and technical competence of the department

16) Ensure the auditing clinical trial files to support regulatory compliance and submissions

17) Prepare teams for audit responses

18) Assist with preparation of department budgets

CRITICAL REQUIREMENTS

  • Qualifications / Skills Required


    1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)


    2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)


    3) Life sciences industry experience

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Director / VP
Function:
  Clinical Research / Affairs
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.