Manager, Clinical Development
Manager, Clinical Development
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Job Description
To build all necessary data/information needed in preparing internal documents/scientific reports related to clinical studies and research activities for aesthetic clinical development programs. Participates in cross-functional teams to keep multiple deliverables moving forward supporting overall botulinum toxin and aesthetic franchise scientific and business strategy.
Responsibilities:
- Prepare scientific reports/presentations related to aesthetic clinical studies using available software and templates. Review/contribute to clinical protocols assist in data interpretation.
- Coordinate advisory meeting agendas activities slide decks and consulting agreements.
- Comply with procedures set forth in relevant operational quality documents investigative protocols with all accompanying regulatory documentation and other directives issued by the management regarding clinical studies.
- Lead study development by applying current electronic document conventions/processes most consistently/accurately to ensure scientific integrity of all processes.
- Receive and complete tasks/assignments from Therapeutic Area MD/SD and Clinical Development leadership with minimal supervision maximizing individual contribution for Therapeutic Area and clinical study team productivity.
- Participate on teams for process improvement initiatives and review key decisions impacting project timelines with management.
- Review clinical study data quality and analyze results including statistical data using available software to assist with ongoing blinded/un-blinded safety and efficacy reviews ensuring scientific integrity of all processes.
- Perform literature/competitive intelligence searches to recognize/resolve scientific and technical problems by applying the most current electronic document conventions and processes consistently and accurately.
- Provide/present key clinical study information to Therapeutic Area and management.
- May lead teams within Therapeutic Area and supervise exempt and/or non-exempt direct reports and mentor function/-therapeutic area personnel.
Qualifications :
- Bachelors/Masters degree in Science related to Field with 11 years experience in the pharmaceutical industry or Pharm-D/PhD with 1years.
- Ability to understand more complex clinical study principles.
- Advanced understanding of appropriate technology necessary to analyze clinical study data generate reports 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 Area operations.
- Must have a proven record of successful projects.
- Experience in multi-faceted broad-based multiple functions/therapeutic areas or clinical functions with in 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.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
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 short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
