Medical Director, Neuroscience Clinical Development
AbbVie
2 months ago
Remote friendly (North Chicago, IL)
United States
$200,500 - $380,500 USD yearly
Clinical Research and Development
Leads the direction, planning, execution, and interpretation of clinical trials or research activities for one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data.
Responsibilities:
- Lead and implement multiple clinical development programs (or one large complex program) in support of the product development plan; oversee project-related education for investigators, site personnel, and AbbVie study staff.
- Lead clinical study teams; monitor study integrity; review/interpret/communicate accumulating safety and efficacy data. Ensure agreed enrollment and timelines for key deliverables with Clinical Operations. Assess and report serious adverse events per policy and regulations.
- Own design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions/responses, and other program documents.
- May oversee Medical/Scientific Directors and Clinical Scientists on related programs.
- May serve on or chair Clinical Strategy Teams; develop a cross-functionally aligned Clinical Development Plan. As CST Chair, may supervise matrix team members and act as Clinical Research representative to ADTs/ALBs.
- Serve as in-house clinical expert for one or more molecules/diseases; coordinate scientific/medical activities with internal stakeholders; contribute to due diligence/business development and translational strategies.
- Act as clinical lead; solicit opinion leader interactions with Medical Affairs/Commercial/other functions.
- Stay current via conferences/literature/training; may represent AbbVie externally.
- Understand and comply with regulatory requirements for clinical studies and global drug development; serve as clinical representative for regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.
Qualifications:
- M.D., D.O., or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
- At least 5 years (7 preferred) clinical trial experience in pharma/academia/equivalent.
- Ability to run a complex clinical research program independently.
- Proven leadership; ability to lead through influence on cross-functional global teams.
- Ability to interact externally and internally to support global scientific and business strategy.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, and clinical strategy/protocol design.
- Excellent oral and written English communication skills.
- Judgment to address complex problems and create solutions.
Benefits (if applicable to role):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligibility for short-term incentive and long-term incentive programs.
Responsibilities:
- Lead and implement multiple clinical development programs (or one large complex program) in support of the product development plan; oversee project-related education for investigators, site personnel, and AbbVie study staff.
- Lead clinical study teams; monitor study integrity; review/interpret/communicate accumulating safety and efficacy data. Ensure agreed enrollment and timelines for key deliverables with Clinical Operations. Assess and report serious adverse events per policy and regulations.
- Own design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions/responses, and other program documents.
- May oversee Medical/Scientific Directors and Clinical Scientists on related programs.
- May serve on or chair Clinical Strategy Teams; develop a cross-functionally aligned Clinical Development Plan. As CST Chair, may supervise matrix team members and act as Clinical Research representative to ADTs/ALBs.
- Serve as in-house clinical expert for one or more molecules/diseases; coordinate scientific/medical activities with internal stakeholders; contribute to due diligence/business development and translational strategies.
- Act as clinical lead; solicit opinion leader interactions with Medical Affairs/Commercial/other functions.
- Stay current via conferences/literature/training; may represent AbbVie externally.
- Understand and comply with regulatory requirements for clinical studies and global drug development; serve as clinical representative for regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.
Qualifications:
- M.D., D.O., or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
- At least 5 years (7 preferred) clinical trial experience in pharma/academia/equivalent.
- Ability to run a complex clinical research program independently.
- Proven leadership; ability to lead through influence on cross-functional global teams.
- Ability to interact externally and internally to support global scientific and business strategy.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, and clinical strategy/protocol design.
- Excellent oral and written English communication skills.
- Judgment to address complex problems and create solutions.
Benefits (if applicable to role):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligibility for short-term incentive and long-term incentive programs.