Senior Medical Director, Clinical Development Neurology

AbbVie•Waltham, MA

1d•$160,500 - $305,000

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 the product’s scientific and business strategy. Manages the design and implementation of clinical development programs in support of an overall Product Development Plan, using medical and scientific principles and knowledge of compliance and regulatory requirements, customers, markets, business operations, and emerging issues. Provides education on project matters to investigators, study-site personnel, and AbbVie study staff. Oversees clinical studies, monitors study integrity, and reviews, interprets, and communicates accumulating safety and efficacy data. In partnership with Clinical Operations, oversees study enrollment and timelines for key deliverables. Assesses and reports serious adverse events for assigned protocols in accordance with corporate policy and regulations. Provides scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents, including their design, analysis, interpretation, and reporting. May oversee Medical Directors, Scientific Directors, and Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating scientific and medical activities with internal stakeholders. May participate in due diligence or other business development activities and, as program needs require, partner with Discovery colleagues on translational strategies. May serve on or chair an Integrated Evidence Strategy Team (IEST), developing a rigorous, cross-functionally aligned and vetted Clinical Development Plan that considers contingencies and alternatives. An IEST Chair may supervise matrix team members and represent Clinical Research on an Asset Strategy Team (AST), contributing clinical development and medical expertise. Acts as a clinical interface and solicits opinion-leader input related to the molecule and disease area. Partners with Medical Affairs, Commercial, and other functions as appropriate and consistent with corporate policies. Keeps current with professional information and technology through conferences, medical literature, and other training. Understands and complies with regulatory requirements for clinical studies and global drug development, and serves as a clinical representative in key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.

Requirements

M.D., D.O., or non-US equivalent M.D. degree with 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 in 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 Product Development Plan.
Oversee project-related education of investigators, study-site personnel, and AbbVie study staff.
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.
May oversee Medical Directors, Scientific Directors, and Clinical Scientists working on the same or related programs.
Provide in-house clinical expertise for the molecule and disease, coordinating scientific and medical activities with internal stakeholders.
May participate in due diligence or other business development activities and contribute to translational strategies with Discovery colleagues as program needs require.
May serve on or chair an IEST and develop a cross-functionally aligned Clinical Development Plan that considers contingencies and alternative approaches.
As IEST Chair, may supervise matrix team members and serve as the Clinical Research representative on an AST.
Solicit opinion-leader input and partner with Medical Affairs, Commercial, and other functions to incorporate cross-functional perspectives into Clinical Development Plans and protocols.
Stay current with professional information and technology through conferences, medical literature, and training.
Understand and comply with regulatory requirements for clinical studies and global drug development, and represent Clinical Research in key regulatory discussions.
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.