Job DescriptionDescription Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. The Manager, Clinical Development (Devices) will have global or regional responsibilities and fulfill the role of Clinical Scientist within the Integrated Evidence Strategy Team (IEST). The Manager, Clinical Development 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 will be based in Irvine, CA.
YOU ARE more than just a title, YOU ARE...First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.
You Will In collaboration with a Therapeutic Area Scientific Director (TA-SD), the
Clinical Scientist will contribute to the design, conduct, analysis, and reporting of clinical trials. The Clinical Scientist 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, 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
- Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).
- Participate in scientific dialogue with internal and external stakeholders on the clinical data relevant to program.
- 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.
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
In this role, we're looking for a leader who will: - Act as an Owner
- Be Excellence Focused
- Act as an Influencer
Additional InformationApplicable 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 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.
