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About the Role

Manages Medical and/or Scientific Directors, leading the planning, execution, and interpretation of clinical trials or research activities. Participates in cross-functional teams to generate high-quality clinical data supporting product strategy.

Responsibilities

• Leads the design and implementation of clinical development programs based on medical and scientific principles, compliance, and regulatory requirements.
• Oversees project-related education of investigators and study site personnel.
• Leads and mentors clinical study teams, monitors study integrity, and reviews/interprets accumulating data on safety and efficacy.
• Ensures study enrollment and timelines for key deliverables in conjunction with Clinical Operations.
• Assesses and reports serious adverse events per corporate policy and regulations.
• Owns the design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions, and responses.
• Manages Medical and Scientific Directors and/or Clinical Scientists, overseeing clinical development activities and personnel.
• Responsible for hiring, onboarding, mentoring, training, and career development of direct reports.
• May chair Clinical Strategy Teams, developing Clinical Development Plans with consideration for contingencies.
• Supervises matrix team members and serves as the Clinical Research representative to Asset Development Teams.
• Acts as the in-house clinical expert for molecules and diseases within the therapeutic area.
• Coordinates and leads scientific activities with internal stakeholders.
• May participate in or lead clinical development contributions to due diligence or business development activities.
• Contributes to the design and implementation of translational strategies in partnership with Discovery colleagues.
• Acts as clinical lead and solicits opinion leader interactions related to the disease area.
• Partners with Medical Affairs, Commercial, and other functions to incorporate cross-functional perspectives into Clinical Development Plans and protocols.
• Stays abreast of professional information and technology to augment therapeutic area expertise.
• Represents AbbVie at key external meetings.
• Understands and complies with regulatory requirements for clinical studies and global drug development.
• Serves as a clinical representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and quality standards.

Requirements

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent degree with relevant therapeutic specialty required.
• Completion of a residency program strongly preferred.
• Completion of a subspecialty fellowship is desirable.
• At least 7 years (9+ years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to run a complex clinical research program independently.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team.
• Must be able to lead and manage through influence.
• Demonstrated commitment to training and development of junior-level staff.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Extensive 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.
• Ability to exercise judgment and address complex problems and create solutions across multiple projects.

Skills

• Clinical trial methodology
• Regulatory and compliance requirements
• Clinical strategy development
• Study protocol design
• Leadership
• Mentoring
• Communication (oral and written English)
• Problem-solving

Location

• US

Work Type

• Full-time
• Travel 20% of the Time

Experience Level

• 7+ years of clinical trial experience
• 9+ years preferred

Education Level

• Medical Doctor (M.D.) or equivalent
• Residency program completion preferred
• Subspecialty fellowship desirable

Salary/Compensations

• USD 248000 - USD 471500 - yearly

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Long-term incentive programs

About the Company

• AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
• We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
• For more information about AbbVie, please visit us at www.abbvie.com.
• Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Equal Opportunity

• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
• Equal Opportunity Employer/Veterans/Disabled.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html