Sr Medical Director, Hematology Clinical Development

Responsibilities

• Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan.
• Oversees project-related education of investigators, study site personnel, and AbbVie study staff.
• Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
• Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
• Designs, analyzes, interprets, and reports scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
• May oversee the work of Medical Directors and/or Scientific Directors, and of Clinical Scientists working on the same or related programs.
• Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects.
• May participate in due diligence or other business development activity.
• Contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
• Serves as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
• Understands the regulatory requirements related to the clinical studies and global drug development and is accountable for complying with those requirements.
• Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment.
• Completion of a residency program strongly preferred.
• Completion of a subspecialty fellowship is desirable.
• 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 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, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
• Excellent oral and written English communication skills.