Senior Medical Director, Immunology Clinical Development
AbbVie
10 hours ago
Remote friendly (North Chicago, IL)
United States
Clinical Research and Development
Responsibilities:
- Manage the design and implementation of one or more clinical development programs supporting the Product Development Plan; oversee project-related education of investigators, study site personnel, and AbbVie study staff.
- Oversee clinical studies to monitor study integrity; review, interpret, and communicate accumulating safety and efficacy data; manage study enrollment and key deliverable timelines (with Clinical Operations); assess and report serious adverse events per policy and regulations.
- Design, analyze, interpret, and report 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.
- Provide in-house clinical expertise for the molecule and disease; coordinate scientific/medical activities with internal stakeholders; may support due diligence/business development; contribute with Discovery on translational strategy.
- May serve on or chair a Clinical Strategy Team (CST) to develop a cross-functionally aligned, vetted Clinical Development Plan; may supervise matrix team members and act as a Clinical Research representative to an Asset Development Team (ADT).
- Serve as a clinical interface; solicit opinion leader input and partner with Medical Affairs/Commercial/other functions to incorporate perspectives into plans and protocols.
- Stay current on medical literature, conferences, and training.
- Understand and comply with regulatory requirements for global clinical development; represent clinical perspectives in key 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 in an academic or hospital environment; residency strongly preferred; fellowship desirable.
- At least 2 years of clinical trial experience in the pharmaceutical industry/academia/equivalent.
- Ability to run a moderate-complexity clinical research program with minimal supervision.
- Ability to perform and elevate others on a cross-functional global team.
- Ability to interact externally and internally to support global scientific and business strategy.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; experience developing clinical strategy and designing study protocols.
- Excellent oral and written English communication skills.
- Manage the design and implementation of one or more clinical development programs supporting the Product Development Plan; oversee project-related education of investigators, study site personnel, and AbbVie study staff.
- Oversee clinical studies to monitor study integrity; review, interpret, and communicate accumulating safety and efficacy data; manage study enrollment and key deliverable timelines (with Clinical Operations); assess and report serious adverse events per policy and regulations.
- Design, analyze, interpret, and report 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.
- Provide in-house clinical expertise for the molecule and disease; coordinate scientific/medical activities with internal stakeholders; may support due diligence/business development; contribute with Discovery on translational strategy.
- May serve on or chair a Clinical Strategy Team (CST) to develop a cross-functionally aligned, vetted Clinical Development Plan; may supervise matrix team members and act as a Clinical Research representative to an Asset Development Team (ADT).
- Serve as a clinical interface; solicit opinion leader input and partner with Medical Affairs/Commercial/other functions to incorporate perspectives into plans and protocols.
- Stay current on medical literature, conferences, and training.
- Understand and comply with regulatory requirements for global clinical development; represent clinical perspectives in key 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 in an academic or hospital environment; residency strongly preferred; fellowship desirable.
- At least 2 years of clinical trial experience in the pharmaceutical industry/academia/equivalent.
- Ability to run a moderate-complexity clinical research program with minimal supervision.
- Ability to perform and elevate others on a cross-functional global team.
- Ability to interact externally and internally to support global scientific and business strategy.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; experience developing clinical strategy and designing study protocols.
- Excellent oral and written English communication skills.