Executive Medical Director

GENERAL

SUMMARY:

Reporting to the VP, clinical development or the CMO, the Executive Medical Director is accountable for the design, execution, and analysis of clinical trials in the Ophthalmology Therapeutic Area.

MAJOR

DUTIES & RESPONSIBILITIES:

* Provides clinical leadership to multidisciplinary study execution teams drawn from clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharm/tox, drug safety, commercial, and alliance partners

* Has lead accountability on the study teams for delivery of study protocols, study conduct, and study readouts

* Organizes and leads scientific advisory board meetings. Interacts with external experts and stakeholders to gather input.

* Serves as medical monitor on clinical studies.

* Serves as the primary clinical author of development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory submissions / correspondence, and project-related documents. Accountable for the accuracy of all medical content of such documents.

* Works with the research organization and the portfolio management team to identify and support new project opportunities.

* Collaborates to identify program risks, and to create and implement mitigation strategies

* Other duties as assigned

QUALIFICATIONS:

Education:

* Medical Degree (M.D.)

* Residency training in Ophthalmology with a preference for subspecialty training in retina

* Board certification/retina fellowship training are a plus

Experience:

* 9+ years of clinical ophthalmology research in the biopharmaceutical industry

* Experience with medical monitoring and oversight of Phase 3 retina clinical trials

* Experience with gene therapy clinical studies

* Experience in other phases (Phase 1, 2,
4) of clinical research.

* Experience with NDA/BLA/MAA submission planning and execution

* Experience in data analysis, data interpretation, and medical writing

Other Qualifications/

Skills:

* Knowledge of ICH-GCP and FDA regulatory guidelines.

* Knowledge of international regulatory guidelines

* Effective written and verbal communication skills, including public speaking

Travel: up to 20%

Physical Requirements and

Working Conditions:

* Physical Activity - Repetitive motions:
Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering:
Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking:
Expressing or exchanging ideas by means of the spoken word.

* Physical Requirements - Sedentary work:
Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

* Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $352,000 - $422,000/yr

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.