Senior Director/Vice President, Clinical Development

Job Description
At Elan, we hold a fundamental belief that our science has the potential to improve patients' lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the areas of neurodegenerative diseases, autoimmune diseases and severe pain.

Elan's commitment to patients is reflected in all that we do; we are a company driven by the knowledge that our work is important and the desire to make a difference. Elan offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.
Primary Objective of Position:

To expand Elan's capabilities for design, conduct, and execution of clinical trials in diseases of the neurological system.

Responsibilities:

Design, conduct, generate clinical study reports, and file to regulatory agencies Phase1, 2 and Phase 3 Clinical trials of products in development

Serve as primary and/or backup medical directors to all phases of clinical trials with respect to site and vendor communications and medical monitoring

Responsible for successful completion of clinical trials, participation in interpretation of results, writing final reports, and filing them to regulatory agencies

Responsible for concept development and design of clinical trials for products moving from research to development. Also provides scientific and medical expertise for protocol development and study conduct.

Serve as medical representative on project teams for compounds in development, including clinical teams, core teams, and liaising with clinical operations

Able to generate multi-year clinical development plans in neurological indications

TRAVEL:
20-30%

Requirements:

MD Degree; PhD with exceptional credentials will also be considered

5+ years of relevant industry experience

Residency training in Neurology, Psychiatry, or a related-field required; fellowship training in a neurodegenerative disease area preferred

Familiarity with CFR part 11 and ICH regulations and guidelines;

Knowledge of pharmaceutical clinical development and ability to effectively apply technical principles, theories, and concepts to clinical drug development and successful execution of clinical trials.

Knowledge of FDA requirements and good clinical practices.

Ability to interpret, evaluate, and present clinical data.

Ability to review and edit written summaries of data reports, presentations, or publications.

Company

Elan

Job Code

State or Province

California

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