Senior Medical Director, Clinical Development Neurology

AbbVie•Waltham, MA

12h

About The Position

Oversees the direction, planning, execution, and interpretation of clinical trials or research activities for one or more clinical development programs. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting product scientific and business strategy. Manages the design and implementation of clinical development programs in support of the overall Product Development Plan, using medical and scientific principles and knowledge of compliance, regulatory requirements, customers, markets, business operations, and emerging issues. Provides clinical expertise for the molecule and disease area, coordinates scientific and medical activities with internal stakeholders, and serves as a clinical representative in regulatory discussions. May contribute to business development and translational strategy activities, and may serve as or chair an Integrated Evidence Strategy Team. The role is accountable for clinical study oversight, study integrity, safety and efficacy data review and communication, enrollment and timelines in partnership with Clinical Operations, serious adverse event assessment and reporting, and the scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, responses, and other program documents. It also supports investigator and study staff education, external opinion-leader engagement, and adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality and regulatory requirements. The position requires an M.D., D.O., or non-U.S. equivalent with a relevant therapeutic specialty, and at least two years of clinical trial experience. Experience with psychedelic drug development is highly preferred. The position offers a comprehensive benefits package that includes paid time off, medical, dental, and vision insurance, a 401(k), and eligibility to participate in long-term incentive programs.

Requirements

M.D., D.O., or non-U.S. equivalent of an M.D. degree with a relevant therapeutic specialty in an academic or hospital environment.
At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
Ability to run a clinical research program of moderate complexity with minimal supervision.
Ability to perform effectively and bring out the best in others on a cross-functional global team.
Ability to interact externally and internally to support a global scientific and business strategy.
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.

Nice To Haves

Completion of a residency program is strongly preferred.
Completion of a subspecialty fellowship is desirable.
Experience with psychedelic drug development is highly preferred.

Responsibilities

Manage the design and implementation of one or more clinical development programs in support of the overall Product Development Plan.
Oversee education of investigators, study site personnel, and AbbVie study staff on project-related matters.
Oversee clinical studies, monitor study integrity, and review, interpret, and communicate accumulating safety and efficacy data.
Partner with Clinical Operations to oversee study enrollment and timelines for key deliverables.
Assess and report serious adverse events for assigned protocols in accordance with corporate policy and regulations.
Design, analyze, interpret, and report scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
Provide in-house clinical expertise for the molecule and disease area, coordinating scientific and medical activities with internal stakeholders.
As program needs require, partner with Discovery colleagues on the design and implementation of translational strategies.
May serve on or chair an Integrated Evidence Strategy Team and develop a rigorous, cross-functionally aligned Clinical Development Plan that considers contingencies and alternative approaches.
When serving as IEST Chair, may supervise matrix team members and represent Clinical Research on an Asset Strategy Team.
Act as a clinical interface and solicit opinion-leader interactions related to the molecule and disease area, partnering with Medical Affairs, Commercial, and other functions as appropriate and consistent with corporate policies.
Stay current in the therapeutic area through conferences, medical literature, and other training.
Understand regulatory requirements for clinical studies and global drug development, comply with those requirements, 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.
May oversee Medical Directors, Scientific Directors, and Clinical Scientists working on the same or related programs.
May participate in due diligence or other business development activities.