Medical Director/Sr. Medical Director, Neuroscience Clinical Development - Psychiatry

About the role

With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities

• Manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues.
• Oversees project-related education of investigators, study site personnel, and AbbVie study staff.
• Oversees study integrity, reviews, interprets, and communicates accumulating data pertaining to safety and efficacy of the molecule. Responsible for assessing and reporting serious adverse events per corporate policy and regulations.
• Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
• Serves on a Clinical Strategy Team as the clinical representative for the protocols for which the incumbent has responsibility. Develops a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members.
• Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
• 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 in Psychiatry is desirable.
• Ability to run a clinical research study with appropriate supervision.
• Strong desire to collaborate in a cross-functional setting.
• Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred. Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.
• Ability to interact externally and internally to support global scientific and business strategy.
• Must possess excellent oral and written English communication skills.

Senior Medical Director 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 Psychiatry residency program strongly preferred.
• At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent. Experience in translational research is preferred.
• 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.
• Must possess excellent oral and written English communication skills.

Pay

$192,500 - $327,000 USD

Where We Work

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.