Clinical Scientist II - Aesthetics

---

Job description

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 he/she 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.

The position supports the Global Development Lead and TA-SD through the following responsibilities:

•Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of products in development. Attends congress and reviews 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. Reviews 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.

<!– job description page –>