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About the Role

Oversees the direction, planning, execution, and interpretation of clinical trials or research activities for a clinical development program in hematology, solid tumors, or cell therapy. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting the overall product scientific and business strategy.

Responsibilities

Manages the design and implementation of one or more clinical development programs supporting an 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.
Has overall responsibility for oversight of 1-2 clinical studies, monitoring overall study integrity, and responsibility for data review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
Overall responsibility for data review / medical monitoring to ensure quality data for both in-house and outsourced studies.
Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
Responsible for 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 Associate Scientific Directors and/or Clinical Scientists working on the same or related programs; provide oversight of Contract Research Organization (CRO) and other vendors on the trials.
Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects.
May participate in 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.
Will serve on an Asset Study Team (AST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial, and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
Stays abreast of professional information and technology through conferences, medical literature, and other available training to augment expertise in the therapeutic area.
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

Bachelors degree in the sciences; advanced degree (e.g., MS, PhD, PharmD) preferred.
Ability to provide input and direction to clinical research with appropriate supervision.
At least 5+ years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
Ability to oversee 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.

Experience Level

5+ years of clinical trial experience

Education Level

Bachelors degree in the sciences
Advanced degree (e.g., MS, PhD, PharmD) preferred

Salary/Compensations

USD 160500 - USD 305000 - 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 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