Seeking a Senior Medical Director - Neurovascular to join our client?s Neurovascular Division (CNV), a member of the Medical Device group within Cardiovascular & Specialty Solutions (CSS) in Irvine, CA.
The Cardiovascular & Specialty Solutions (CSS) Group consists of six diverse businesses aside from Neurovascular which serve a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, and Reprocessing.
Neurovascular (CNV) Division is one of the leaders in the medical device industry. Our client?s implants and instruments are used by interventional neuroradiologists, neurosurgeons and neurologists, to treat patients with conditions resulting from hemorrhagic and ischemic stroke. Our client?s environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
The Senior Medical Director will have global medical affairs responsibility in support of the of diagnosis and treatment of vascular disease in the central nervous system to co-develop and deliver global innovation and life cycle business strategy. This role will also establish long term product opportunities, as well as unmet medical needs, and evidence needed for development programs and post market products. The Senior Medical Director will Shape the industry and build strong relationships externally with key customers and stakeholders (Key Opinion Leaders, Surgeons, Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends, understand clinical/medical insights, unmet medical needs and global standards of care to deliver quality products/solutions.
The Senior Medical Director will:
- Ensure the development and execution of product and/or procedural evidence generation and dissemination strategies for company sponsored and investigator initiated research.
- Chair the Clinical Research Committee to ensure medical scientific alignment between Clinical Research and the company?s strategic needs.
- Participate in Key Governance Forums, including Global Management Boards, Cross Functional Leadership Teams, Portfolio Management Teams, Protocol Review Committee, Safety and Quality Review Boards.
- Engage Key Opinion leaders, Professional Societies, Payers and Providers to understand trends in care, uncover critical insights.
- Provide support to Franchise Marketing, R&D, Communications, Legal, QA/Risk Management/Product Safety and Commercial teams by providing medical and scientific insights to drive optimal business strategic direction and tactical business activities.
- Collaborate with evidence generation colleagues from Preclinical Research, Clinical Research and Evidence-Based Medicine (EBM) teams in the USA and internationally to develop global strategies for evidence generation for new and existing products in order to support regulatory approval/clearance, health technology assessment, customer access and post-marketingsupport.
- Provide scientific and medical expertise, medical oversight and approval for clinical trial concept, design, analysis and reporting of clinical research in assigned areas.
- Provide medical oversight for the development of materials to be used by Clinical Operations for study execution (investigator brochures, training materials, etc.).
- Oversee MDs (internal MDs or consultants) who perform the role of medical monitor for company sponsored clinical studies. May perform the role of medical monitor for certain company sponsored pre-approval clinical studies.
- Provide medical input and expertise in the analysis of study results.
- Work with Regulatory and Clinical partners to prepare report on clinical investigations in preparation for submission to regulatory agencies and/or for publication, to meet evidence requirements.
- Provide medical insights/expertise to the development teams for the risk assessment review for new products and reviews and approves the final risk management report for all new products.
- Account for the medical content of internal product documentation and regulatory submissions for new products and for renewals.
- Approve Design History Files, Technique Guides and Clinical EvaluationReports (CERs) as part of the creation of product-specific design dossiers/technical files.
- Provide expert medical response to unsolicited medical information requests.
- Experience and focused training in neurovascular and neuroendovascular disease processes and therapeutics is required
- A minimum of 7years relevant experience in post graduate medical education (beyond initial licensure) including: specialty residency, fellowship or subspecialty training, clinical practice, dedicated research, or other related advanced training/experience is required
- A current license to practice is preferred and Board Certification or an equivalent is strongly preferred
- Two or more years?experience in clinical practice as an attending level physician is strongly preferred
- Significant experience with clinical research is required
- Strong leadership skills and demonstrated ability to build successful relationships with internal and external partners globally is preferred
- Strong communication and negotiation skills to successfully influence and implement policy with key customers and partners is preferred
- Must be able to collaborate well with multiple partners and work effectively in a matrix environment
- Previous industry experience leading Medical/Clinical/R&D teams in a regulated, commercial biomedical or medical device business is preferred
- Membership and leadership roles in specialty Professional Societies is desirable
- Capability, expertise and success in building teams to meet the needs of a global set of businesses serving different clinical specialties or therapeutic areas will be needed
- Demonstrated success in medical data generation, interpretation and publication highly preferred
- Experience in product risk evaluation and mitigation is preferred
- A minimum of a MD/MB/DO or equivalent is required. Additional advanced degrees are preferred
OCSI.co is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, arrest and conviction records, or any other characteristic protected by law. OCSI.co is a participant in the U.S. Federal E-Verify program. Women, minorities, disabled and veterans are encouraged to apply.