Sr Medical Director, Hematology Clinical Development

AbbVie•North Chicago, IL

17h

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 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, coordinates scientific and medical activities with internal stakeholders, and may contribute to due diligence, business development, and translational strategies. The role oversees clinical studies and study integrity, reviews and communicates accumulating safety and efficacy data, and partners with Clinical Operations on enrollment and timelines. It is responsible for serious adverse event assessment and reporting, as well as the scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. Depending on program needs, the role may oversee Medical Directors, Scientific Directors, or Clinical Scientists; chair a Clinical Strategy Team; supervise matrix team members; and represent clinical research on asset development leadership teams. The role engages with opinion leaders and partners across Medical Affairs, Commercial, and other functions to incorporate cross-functional perspectives into clinical development plans and protocols. It stays current on relevant professional information and technology, represents the clinical function in regulatory discussions, and ensures compliance with global regulatory requirements, Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.

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 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 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 clinical development programs supporting the Product Development Plan.
Oversee investigator, study-site personnel, and AbbVie study-staff education related to 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 applicable regulations for assigned protocols.
Design, analyze, interpret, and report the scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
Provide in-house clinical expertise for the molecule and disease and coordinate related scientific and medical activities with internal stakeholders.
Contribute to due diligence or other business development activities as appropriate.
Partner with Discovery colleagues on translational strategy design and implementation as program needs require.
Potentially serve as 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, potentially supervise matrix team members and represent clinical research on an Asset Development Team or Asset Development Team Leadership Board.
Solicit opinion-leader input and partner with Medical Affairs, Commercial, and other functions on molecule- and disease-area activities, consistent with corporate policies.
Maintain therapeutic-area expertise through conferences, medical literature, and other training.
Understand and comply with regulatory requirements for clinical studies and global drug development, and represent the clinical function in key regulatory discussions.
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.