At ProClinical, we are seeking an individual to fill the role of Director/Associate Director of Clinical Development, based in Boston, MA. The successful individual will work closely with the head of development and will independently lead clinical development of our novel biological candidates with an emphasis on nephrology and immunology/rheumatology indications.
- Provide leadership and medical/basic science insight to clinical development group functions.
- Develop, write and execute clinical development plans and protocols from phase 1 through 3.
- Work with regulatory personnel to develop strategy and file necessary documentation
- Collaborate with clinical operations team and CROs to successfully execute studies
- Integrate pharmacokinetics, biomarkers, pharmacogenetics and pharmacogenomics, biostatistics and regulatory strategy into clinical development plans with appropriate cross-disciplinary support.
- Supervise and be accountable for the production of clinical study reports.
- Provide guidance for clinical data organization and interpretation.
- Monitor clinical trials for safety and, when appropriate, efficacy.
- Assist in the development of case report forms used to capture data from clinical protocols
- Identify clinical investigators and coordinate their activities in the conduct of clinical trials and advisory board meetings
- Manage the preparation of data presentations for manuscripts, and congress presentations.
- Present clinical trial data and development plans to senior management team.
Skills And Qualifications
- Medical degree (MD, DO) with Nephrology or Rheumatology Board Certification. Candidates who are completing or have recently completed fellowship training welcome.
- Additional clinical research or statistics training reflected in M.S. or M.P.H. degree preferred but not required.
- Firm grasp of immunopathologic renal disease or basic immunology expertise.
- Excellent written, verbal, and interpersonal communication skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Herman Bradford, Jr. at (+1) 6463671088 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.