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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTube andLinkedIn.
Job Description
The Sr. Manager, Clinical Development (Devices) will have global or regional responsibilities and fulfill the role of Clinical Scientist and/or Clinical Science Lead within the Integrated Evidence Strategy Team (IEST). The Clinical Scientist II should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members.
The position may be based in Irvine, CA (preferred) or Branchburg, NJ. We are looking for a first class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.
Responsibilities:
- In collaboration with a Therapeutic Area Scientific Director (TA-SD), the Clinical Scientist and/or Clinical Science Lead will contribute to the design, conduct, analysis, and reporting of clinical trials. The Clinical Scientist and/or Clinical Science Lead will apply scientific training and clinical research experience to support all aspects of device and product development, from facilitating the transition from pre-clinical discovery to supporting the registration and commercialization of a product.
- Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of products in development. Attend congress and review literature to develop and augment expertise in therapeutic area.
- Help develop program strategy including the clinical development plan, Integrated evidence plan, product lifecycle plans, target product profiles and draft labels. Review competitive landscape and help identify and evaluate business development opportunities.
- Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).
- Participate in scientific education of internal and external stakeholders on the pre-clinical and clinical data relevant to program. Engage opinion leader interactions to build pipeline awareness and foster research collaborations.
- Contribute to the scientific content of Study Protocols, Investigator Brochures, IDFUs, Clinical Study Reports, Informed Consent Forms, and regulatory documents.
- Contribute to creation of electronic database, investigator meetings, and associated training documents and review data completeness and fidelity throughout study conduct.
- Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.
Qualifications
- Relevant science degree (e.g., Masters, MD, PharmD, PhD); Scientific knowledge and experience in the relevant Therapeutic Area (Devices) preferred.
- Minimum 5 years of overall work experience or equivalent combination of experience and education.
- Minimum 4 years of clinical/research experience in the pharmaceutical/device industry preferred.
- Ability to travel up to 15% of time, including international travel.
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 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.
US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html.
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