Director, GI Clinical Development & Medical Affairs in San Diego, CA at Apex Life Sciences

Date Posted: 5/13/2018

Job Snapshot

Job Description


Client Job Description:

The Director, Clinical Development & Medical Affairs will provide strategic direction to the Clinical Development and Medical Affairs functions for the Company's GI diagnostics and therapeutic product lines. S/he will provide clinical and technical information to enable ongoing clinical programs in the area of GI diagnostics and therapeutics.   He/she will liaise closely with research and development, regulatory and commercial/reimbursement functions to design and implement clinical studies that help drive successful market and patient access for diagnostic and therapeutic products.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Direct the development of clinical sections of regulatory documents, and represent the clinical line-function in meetings with regulatory agencies

  • Develop, implement, and maintain clinical evidence development plans for all promoted diagnostic and therapeutic products
  • Develop and execute a clinical publication plan to support the promotional efforts of the products
  • Develop and maintain relationships with Key Opinion Leaders (KOLs) to deliver high value clinical studies, and medical and scientific presentations that help further awareness of products
  • Make medical and scientific presentations to key stakeholders in academia, managed care and reimbursement to help establish medical value and clinical utility of  products
  • Support thought leaders in developing concepts for investigator supported clinical and outcomes studies.
  • Moderate peer discussions and reviews through regional and national advisory panels and diagnostic education programs.
  • Serve as a clinical leader on Product Review Committees by providing insight to support advancement of programs.
  • Respond to and supply necessary clinical data to key internal stakeholders including commercial, clinical development and regulatory affairs, as well as to external stakeholders.
  • Oversee coordination with brand teams to develop and implement superior product and training programs to support the educational needs of field teams.
  • Able to work successfully within a matrix environment, as a member of several teams, including development and commercial, during all phases of product (diagnostic and drug) development
  • Lead internal clinical review of both sponsored and external clinical studies, and assist with the development of clinical study documents.
  • Assist in the development of clinical sections of regulatory documents, and lead the clinical interface with regulatory authorities relating to GI diagnostic and drug products
  • Provide medical/promotional reviews for internal customer groups (such as Sales, Marketing, and Managed Care).
  • Participate in cross functional projects as required.
  • Other duties as assigned.


EDUCATION AND/OR EXPERIENCE

  • MD, PhD or Pharm D degree with minimum of 10 years of direct experience within the pharmaceutical, diagnostic, or biotechnology industry is required.
  • Previous experience in clinical diagnostics tests and the device industry is highly desired. 
  • In depth experience with designing and managing clinical trials, data analysis and publication planning especially related to diagnostic test development, is critical. 
  • Expertise in scientific/technical writing, such as study protocols, meeting abstracts, clinical summary reports including clinical data analysis to support either FDA submissions or peer-reviewed publications is required. 
  • Experience in medical information and in overseeing field-based activities is highly desirable. 
  • Must be familiar with the application and implementation of basic statistical analysis methods as they apply to clinical trial data. 
  • Good computer skills including Word, PowerPoint, Excel, ACCESS, SAS, or a comparable statistical database and Prism or similar graphical program. 
  • Experience in building relationships with external investigators or partners and cross-functional internal departments to execute development programs is essential.

For additional information or to apply for this position please contact:

Vickie Dagit, Recruiter

vdagit@apexlifesciences.com

919-334-0178

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.