Has responsibility for review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, may be responsible for oversight of study enrollment and overall timelines for key deliverables.
Contributes to design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents.
May be asked to contribute to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members.
Participates in 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.
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. May be asked to contribute to regulatory responses and discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) preferred.
Ability to provide input and direction to clinical research with appropriate supervision.
Strong desire to collaborate in a cross-functional setting.
Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.
Ability to interact externally and internally to support global scientific and business strategy.
Must possess excellent oral and written English communication skills.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.
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
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Dental insuranceVision insurance401(k)Paid time offPerformance bonus
Additional Information
Purpose:
With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall product scientific and business strategy.
Abbvie · San Francisco, CA