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About the Role

Leads the direction, planning, 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 supporting overall product scientific and business strategy.

Responsibilities

• Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan.
• Oversees project-related education of investigators, study site personnel, and AbbVie study staff.
• May have responsibility for leading clinical study teams, monitoring overall study integrity, and reviewing, interpreting, and communicating accumulating data pertaining to safety and efficacy.
• Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables.
• Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
• May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
• May serve on or co-chair Integrated Evidence Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan.
• Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders.
• May participate in or lead clinical development contributions to due diligence or other business development activity.
• As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
• Acts as clinical lead and actively solicits 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, to ensure broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training to augment expertise in the therapeutic area.
• May represent AbbVie at key external meetings.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and 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 all other quality standards in conducting research.

Requirements

• At least 8 years 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 through influence.
• 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 for one or more projects.

Skills

• Hematology experience preferred
• Non-Hodgkin Lymphoma (NHL) experience strongly preferred

Location

• US & Puerto Rico

Work Type

• Travel: Yes, 20% of the Time

Experience Level

• 8 years of clinical trial experience

Education Level

• Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) preferred.

Salary/Compensations

• USD 206500 - USD 393000 - yearly

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• Eligible to participate in our short-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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
• For more information about AbbVie, please visit us at www.abbvie.com.
• Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

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