Johnson & Johnson Careers
ASSOCIATE DIRECTOR MEDICAL AFFAIRS
Requisition ID: 0596190328
CERENOVUS is currently recruiting for an Associate Director, Medical Affairs to be located in Irvine, CA.
CERENOVUS is a global neurovascular company that offers a broad portfolio of devices including aneurysm coils, vascular reconstruction devices, stent retrievers and other technologies used in the endovascular treatment of cerebral aneurysms and stroke, minimally invasive solutions for stroke prevention and management, and the treatment of cerebral arteriovenous malformations. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding. We are one of the fastest growing businesses within J&J medical devices.
Every six seconds someone dies from a stroke. Stroke can be caused either by a clot obstructing the flow of blood to the brain (ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (hemorrhagic stroke). CERENOVUS is committed to changing the trajectory of stroke by providing physicians with innovative technologies to push the boundaries of what’s possible in neurovascular intervention. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.
The Medical Affairs Associate Director is a key executional partner with colleagues in neurovascular product development by providing medical and scientific input to internal product ideation & development, risk-benefit analyses, and conceptual and hands-on product evaluation as well as medical and clinical research insights. This role collaborates closely with the cross-functional teams (e.g., medical operations, R&D, clinical research, regulatory affairs) throughout the product lifecycle to support and ensure product safety, effectiveness, and evidentiary needs are met for successful commercialization and adoption of products.
DUTIES & RESPONSIBILITIES
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position’s responsibilities include, but are not limited to:
· Serving as the primary medical representative for new product development projects. The main responsibilities include being the medical core team member on all product development project teams.
· Supporting the generation of the preclinical & clinical evidence strategies to support clinical claims and participating in characterizing the product's capabilities and clinical workflows in collaboration with the Marketing, R&D, and other development team members.
· Working with cross-functional partners, e.g., R&D, Clinical Research, Regulatory Affairs, Quality & Compliance, Pre-Clinical, Health Economics & Market Access and Professional Medical Education on product development and pre- and post-approval clinical evidence activities.
· Partnering with Clinical Research in the development and execution of product and/or procedural evidence generation and dissemination strategies.
· Supporting early product introduction to the market supporting launches as well as internal & external training.
· Responsible for communicating business related issues or opportunities to next management level.
· Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
· Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
· Performs other duties assigned as needed.
• A minimum of a bachelor’s degree is required, Master of Science or PhD are preferred.
• A minimum 8 years relevant experience in medical affairs/related functionsis required.
• Significant experience with preclinical and clinical research is required.
• Neurovascular experience is preferred.
• 3 years people leadership experience is preferred.
• Previous industry experience working with Medical/Clinical/R&D teams in a highly regulated, commercial medical device business is highly preferred.
• Demonstrated success in medical data generation, interpretation and preclinical testing is highly preferred.
• This positions is located in Irvine, CA and relocation is available.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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