Sr Medical Director, Hematology Clinical Development

AbbVie•Waltham, IL

19h

About The Position

The Sr Medical Director, Hematology Clinical Development oversees the direction, planning, execution, and interpretation of clinical trials or research activities for one or more clinical development programs. The role participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data that supports product scientific and business strategy. The position manages clinical development program design and implementation in support of product development plans, based on medical and scientific principles and knowledge of compliance and regulatory requirements, customers, markets, business operations, and emerging issues. It provides clinical expertise for the molecule and disease area, supports global drug development and regulatory discussions, and ensures research is conducted in accordance with Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards. The role may lead a Clinical Strategy Team, oversee other medical or scientific directors and clinical scientists, contribute to translational strategies and business development activities, and serve as a clinical representative to product development leadership. It also engages with external opinion leaders and internal partners to bring cross-functional perspectives into clinical development plans and protocols.

Requirements

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-U.S. 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 in support of 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.

Responsibilities

Manage the design and implementation of one or more clinical development programs in support of an overall 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 in accordance with corporate policy and regulations for assigned protocols.
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 related scientific and medical activities with internal stakeholders.
May participate in due diligence or other business development activities.
As program needs require, partner with Discovery colleagues on translational strategy design and implementation.
May serve on or chair a Clinical Strategy Team and develop a rigorous, cross-functionally aligned Clinical Development Plan that considers contingencies and alternative approaches.
When serving as Clinical Strategy Team Chair, may supervise matrix team members and represent Clinical Research on an Asset Development Team and Asset Development Team 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 and consistent with corporate policies.
Maintain therapeutic-area expertise through conferences, medical literature, and other training.
Understand regulatory requirements for clinical studies and global drug development and comply with those requirements.
Serve as a clinical representative in key regulatory discussions.
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards in research.