Manager, Aesthetics Clinical Development

Regulatory Toolkit; Irvine (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

AbbVie seeks a seasoned professional to prepare scientific reports for clinical trials, review protocols, and ensure data integrity across studies. You will lead documentation and contribute to presentations, with emphasis on accuracy and regulatory alignment.

The role requires advanced degrees in science and substantial experience in pharmaceutical research, with strong communication and project leadership skills. On-site in Irvine, CA.

Qualifications

• Bachelor's/Master’s degree in Science or related field.
• PharmD/PhD with 1+ year in pharma or related field.
• Ability to analyze clinical study data and generate reports.

Responsibilities

• Prepare scientific reports/presentations for clinical trials using standard templates.
• Coordinate advisory meeting agendas, activities and slide decks.
• Ensure compliance with IQS and study protocols; manage timelines.

Skills

Scientific reporting

Data interpretation

Literature searches

Team collaboration

Education

Bachelor's/Master's in Science

PharmD/PhD with 1+ year

Job description

About AbbVie

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.

Purpose:

To build all necessary data/information needed in preparing internal documents/scientific reports
related to clinical trials and; to keep multiple reports moving forward simultaneously through multi-tasking.

Responsibilities:

• Prepare scientific reports/presentations related to clinical trials using available software and templatesand; review/contribute to clinical protocols, by utilizing expertise, to assist in interpretation of data.
• Coordinate advisory meeting agendas, activities and slide decks and consulting agreements
• Comply with procedures set forth in relevant IQS documents and Study protocols and other directivesissued by the management regarding clinical studies.
• Lead the study development by applying most current electronic document conventions/processesmost consistently/accurately to ensure scientific integrity of all processes.
• Responsible for receiving and completing tasks and assignments from function, Therapeutic Area MDor Scientific Staff within timeline with minimal supervision and; maximizing individual,function/therapeutic area and team productivity.
• Participate on teams for process improvement initiatives and review key decisions impacting projecttimelines with management.
• Apply experience to analyze clinical study data, including statistical data using available software toassist with ongoing blinded/un-blinded PK, safety and efficacy reviews and ensure the scientific integrityof all processes.
• Perform literature/competitive intelligence searches to recognize/resolve scientific and technicalproblems by applying the most current electronic document conventions and processes consistently andaccurately.
• Provide/present key clinical study information to function/therapeutic area and management.
• May lead teams within therapeutic area and supervise exempt and/or non-exempt direct reports andmentor function/-therapeutic area personnel.

• Bachelors/Master’s degree, in Science related to Field with 11+ years’ experience in thepharmaceutical industry or Pharm-D/PhD with 1+years
• Ability to understand more complex clinical study principles
• Advanced understanding of appropriate technology necessary to analyze clinical study data, generatereports and create presentations, posters and manuscripts
• Experience in team, drug development, and scientific project leadership or related.
• Experience supporting clinical research, drug development and/or function/therapeutic areaoperations.
• Must have a proven record of successful projects.
• Experience in multi-faceted, broad-based multiple functions/therapeutic areas or clinical functions within depth knowledge of clinical study issues.
• Ability to appropriately and effectively use resources to complete tasks and meet required timelines.
• Ability to produce work of the highest quality by paying attention to detail
• Must possess good oral and written communication skills

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

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