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Manager, Clinical Development

Inspiration, imagination, and innovation. Here at Aerie Pharmaceuticals, we share this passion for finding new approaches to protecting vision. United by great science, deep clinical insight, and a singular focus on your ophthalmic needs, we see the possibilities ahead and invite you to join us in creating the future of eye care.


Aerie Pharmaceuticals seeks qualified candidates for a full-time position in our Clinical department is for the West Coast Region.
 
Overall Purpose: 
Responsible for collaborating closely with the Director(s), Clinical Development, as well as cross-functional study teams to design, plan and interpret data from published research and clinical trials; support Clinical Operations in the activities associated with execution of clinical trials and data collection activities.  Works with clinical leadership on the design and authoring of clinical protocols and final study reports.  May assist Clinical Operations in the selection and recruitment of clinical investigators and negotiate study design and appropriate endpoints /outcomes with investigators and KOLs.  Responsible for assigned clinical trials from Phase 1-3 as a member or leader of a cross-functional Clinical Sub-Team.  Responsibilities may include ongoing data listings reviews in collaboration with Clinical Operations and the Biostatistician /Data Manager. 
 
Duties & Responsibilities, Essential Job Functions:

  • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. 
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations. 
  • May be required to manage activities of two or more clinical projects through subordinate managers.
  •  May need to travel (up to 20%) including investigative site co-monitoring visits with CRAs. Responsible for assisting with the preparation of clinical sections of Regulatory submissions.

 
Qualification Requirements:
Knowledge & Abilities:
·         Knowledge of regulatory requirements and ICH guidelines.  Knowledge of and experience in drug development process through all phases.  Excellent verbal and written ability.  Requires the ability to interact across functional areas.  Ability to gain cooperation of others and to provide direction, leadership and supervision to subordinates.  Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
Education & Experience:
Med Affairs Mgmt II:

  • M.D. or Ph.D. or O.D. or PharmD, or M.Sc. (with 2+ years of pharmaceutical drug development experience) in a scientific discipline. Requires previous project coordination or management experience.  Relevant pharmaceutical experience also required. Experience in ophthalmology and/or drug development preferred.

 
Med Affairs Mgmt III:

  • M.D. or Ph.D. or O.D. or PharmD, or M.Sc. (with 5+ years of pharmaceutical drug development experience) in a scientific discipline. Requires previous project coordination or management experience.  Relevant pharmaceutical experience also required. Experience in ophthalmology and/or drug development preferred.

 
Training Requirements:
Training to pertinent clinical research procedures, documents, and methodologies, safety, GCP/ICH requirements.
Work Environment
Standard office environment, multiple floors with stairs.
Travel required.
To perform this job successfully, and individual must be able to perform each essential duty satisfactorily.  The requirements listed above are representative of the knowledge, skills and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 

Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.

Manager, Clinical Development

Irvine, CA
Full Time

Published on 03/11/2020