Sr Medical Director, Hematology Clinical Development

AbbVie•Waltham, MA

1d•$211,000 - $400,500

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 that supports product scientific and business strategy. Manages clinical development programs in support of the overall Product Development Plan, applying 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, and may contribute to translational strategies, due diligence, and business development activities. Has overall responsibility for clinical study oversight, including study integrity, safety and efficacy data review and communication, enrollment and timelines in partnership with Clinical Operations, and reporting serious adverse events as required. Leads the design, analysis, interpretation, and reporting of 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. May serve on or chair a Clinical Strategy Team and, as chair, help develop a cross-functionally aligned Clinical Development Plan, supervise matrix team members, and represent Clinical Research on asset development bodies. Engages with opinion leaders and partners with Medical Affairs, Commercial, and other functions to incorporate broad cross-functional perspectives into development plans and protocols. Keeps current with professional information and technology, understands regulatory requirements for clinical studies and global drug development, serves as a clinical representative in key regulatory discussions, and ensures compliance with 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 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 internally and externally 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.

Responsibilities

Manage the design and implementation of one or more clinical development programs in support of an overall Product Development Plan.
Oversee investigator, study-site personnel, and AbbVie study-staff education related to assigned projects.
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 in accordance with corporate policy and regulations for assigned protocols.
Lead the design, analysis, interpretation, and reporting of 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 and coordinate scientific and medical activities with internal stakeholders.
May participate in due diligence or other business development activity and contribute to translational strategies with Discovery colleagues as program needs require.
May serve on or chair a Clinical Strategy Team and help develop a rigorous, cross-functionally aligned Clinical Development Plan.
When serving as Clinical Strategy Team Chair, may supervise matrix team members and represent Clinical Research on an Asset Development Team or ADT Leadership Board.
Act as a clinical interface and solicit opinion-leader interactions related to the molecule and disease area; partner with Medical Affairs, Commercial, and other functions as appropriate.
Maintain professional expertise through conferences, medical literature, and other training.
Understand and comply with regulatory requirements related to 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.