Director, 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 in our Irvine, CA office.
The Director, Clinical Development is responsible for collaborating closely with the clinical and cross-functional team leads to design, plan and interpret data from published research and clinical trials; and support Clinical Operations in the activities associated with execution of clinical trials and data collection activities.
Duties & Responsibilities, Essential Job Functions:
- Works with senior management and clinical leadership to design, author and implement clinical protocols, data collection systems and final 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 directing and leading assigned clinical trials from Phase 1-3 as a member or leader of a cross-functional Core Team.
- Responsibilities may include adverse event reporting and safety monitoring, in collaboration with Medical Monitor and ongoing data listings reviews in collaboration with Clinical Operations and the Biostatistician /Data Manager.
- Driver of clinical research activities to complete studies on time and within budget.
- Responsible for assisting in authoring the clinical sections of regulatory documentation.
- 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 influence the thinking of, or gain acceptance of concepts, novel ideas, exploratory evaluations and others that maybe new or new to Aerie.
- May be required to manage activities of two or more clinical projects with or without support from clinical scientists.
- Responsibilities may include site visits with CRAs with up to 30% travel to build relationships with investigators and KOLs, particularly in new-to-Aerie therapy areas.
- Responsible for the authoring and review planning /preparation of clinical sections of Regulatory submissions.
Knowledge & Abilities:
· Knowledge of regulatory requirements and ICH guidelines. Knowledge of and experience in drug development processes through all phases.
· Excellent verbal and written communication skills. Must be able to interact across functional areas and serve as a “hub” within a cross-functional team, understanding the research data and able to translate that into a clinical study then report the data to regulators.
· Ability to gain cooperation of others and to provide direction, leadership and supervision to subordinates. Ability to work with limited supervision and must be able to demonstrate good attention to detail
· May also be involved in the generation and review of scientific manuscripts for publication or presentation of Aerie data.
Education & Experience:
- Advanced degree (M.D., Ph.D., O.D. or PharmD.) in a scientific discipline. Experience in ophthalmology preferred
- Previous project coordination or management experience, and supervisory experience are preferred. Strong organizational skills are required
- Corporate pharmaceutical /device /biological development experience required. Experience with the drug approval process through marketing authorization would be a plus.
Relevant training pertinent to clinical research procedures, documents, and methodologies, safety, GCP/ICH requirements is desirable but not required.
Standard office environment, multiple floors with stairs and elevator.
Travel required (up to ~30%).
To perform this job successfully, an 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.