Company Description
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 (https://www.tiktok.com/@abbvie) .
Job Description
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more.
With our own research and development team focused on driving innovation in aesthetics, we're committed to providing the most comprehensive science-based product offerings available.
Uses strong medical and scientific principles to oversee long-term strategy for clinical trial design activities across multiple indications and products in Aesthetics, with special focus on safety planning and monitoring, from early development to post-market studies.
Contributes to the review of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
Has responsibility for oversight of clinical studies safety monitoring, with special attention to the planning, collection, monitoring, interpretation and dissemination of clinical data.
Leads the work of clinical trial medical monitors, including performance and talent management, coaching and development.
Collaborates with clinical-trial-related education of investigators, study site personnel, and AbbVie staff
Represents CDSI-SC in cross-functional discussions related to the collection and interpretation of data in clinical trials.
Contributes to the development of rigorous, scientifically sound, cross-functionally-aligned, Clinical Development Plan and Integrated Evidence Plan in collaboration with matrix team members.
Understands and applies pharmacology, immunology, dermatology, anatomy and toxicology as needed to advise clinical study design and interpretation of results.
Analyzes and interprets aggregate clinical trial safety data in partnership with biostatistics and communicates these analyses and interpretation to internal and external stakeholders.
Participates in key opinion leader interactions; partners with Medical Affairs, Commercial (including AMI) 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 areas.
Responsible for understanding the regulatory requirements related to the clinical studies and global clinical development and accountable for complying with those requirements.
May be asked to contribute to regulatory responses and discussions with Health Agencies.
Participates in meetings with health agencies to discuss safety and efficacy data related to clinical trials.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Proactively engages, inspires, coaches and mentors scientific teams to foster team development and innovation in trial design.
Qualifications
Medical Doctor (M.D), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
Strong desire to collaborate in a cross-functional setting.
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols.
Clinical trial experience in the pharmaceutical or medical device industry, academia, or equivalent is preferred.
Experience running a clinical research study.
Ability to interact externally and internally to support global scientific and business strategy, including global health agencies.
Proven ability to lead cross-functionally in a collaborative environment expected.
Must possess excellent oral and written English communication skills.
Medical Device or Pharmaceutical safety experience a plus.
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?
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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 Company's sole and absolute discretion unless and until paid and may be modified at the Company's 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, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Salary: $200,500 - $382,000
