Executive Medical Director - Neuroscience Clinical Development - Toxins

AbbVie•Waltham, MA

31d•$234,000 - $444,000

About The Position

Leads the direction, planning, execution, and interpretation of clinical trials or research activities for one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. The role is focused on neuroscience clinical development involving toxins. The position owns the design and implementation of clinical development programs, leads clinical study teams, monitors study integrity, and reviews, interprets, and communicates accumulating safety and efficacy data. It is responsible for the scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. The role may oversee Medical and/or Scientific Directors and Clinical Scientists, and may chair Clinical Strategy Teams. As an in-house clinical expert, the role coordinates scientific and medical activities with internal stakeholders, solicits opinion-leader interactions, and partners with functions including Medical Affairs and Commercial. It also represents clinical development in regulatory discussions, supports translational strategies and business development activities as needed, and ensures that research complies with Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards. Travel is required 25% of the time.

Requirements

M.D., D.O., or non-U.S. equivalent M.D. degree with relevant therapeutic specialty in an academic or hospital environment.
At least 5 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
Ability to independently run a complex clinical research program.
Proven leadership skills and ability to bring out the best in others on a cross-functional global team; must be able to lead through influence.
Ability to interact internally and externally to support a global scientific and business strategy.
Extensive knowledge of clinical trial methodology and regulatory and compliance requirements governing clinical trials.
Experience developing clinical strategy and designing study protocols.
Excellent oral and written English communication skills.
Ability to exercise judgment, address complex problems, and create solutions for one or more projects.

Nice To Haves

Completion of a residency program is strongly preferred.
Completion of a subspecialty fellowship is desirable.
Seven years of clinical trial experience is preferred.

Responsibilities

Lead the design and implementation of multiple clinical development programs, or one large, complex program, in support of the overall product development plan.
Oversee project-related education of investigators, study-site personnel, and AbbVie study staff.
Lead clinical study teams and monitor overall study integrity; review, interpret, and communicate accumulating safety and efficacy data.
Work with Clinical Operations to support agreed-upon study enrollment and timelines for key deliverables.
Assess and report serious adverse events in accordance with corporate policy and regulations for assigned protocols.
Own the design, analysis, interpretation, and reporting of scientific content in protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
May oversee Medical and/or Scientific Directors and Clinical Scientists working on the same or related programs.
May serve on or chair Clinical Strategy Teams and develop a rigorous, cross-functionally aligned Clinical Development Plan that considers contingencies and alternative approaches.
As Clinical Strategy Team Chair, may supervise matrix team members and represent Clinical Research on Asset Development Teams and Asset Development Team Leadership Boards.
Serve as an in-house clinical expert for molecules and diseases in the therapeutic area, coordinating and leading relevant scientific and medical activities with internal stakeholders.
May contribute to due diligence or other business development activities and, as needed, partner with Discovery colleagues on translational strategies.
Act as clinical lead and solicit opinion-leader interactions, partnering with Medical Affairs, Commercial, and other functions as appropriate and consistent with corporate policies.
Maintain therapeutic-area expertise through conferences, medical literature, and training; may represent AbbVie at external meetings.
Understand and comply with regulatory requirements for clinical studies and global drug development, and serve as a clinical representative in key regulatory discussions.
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.