Job Description

　　Company Information

　　Thermo Fisher Scientific is the world leader in serving science, with revenues of $45 billion, 130,000 employees and one of the largest investments in R&D in the industry. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, tackle sophisticated analytical challenges, improve patient diagnostics and increase laboratory efficiency. When you are part of the team at Thermo Fisher Scientific, you'll do important work, such as helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals! You will be part of a successful, growing global organization that values performance, quality and innovation.

　　Position Summary

　　Our Genetic Sciences Division (GSD) based in South San Francisco is at the forefront of innovation for genetic analysis research and clinical applications. The Genetic Testing Solutions (GTS) Business within GSD is a cross-platform organization designed to accelerate growth in the clinical space. We develope products/solutions for key applied clinical markets such as infectious disease, oncology Pharmacogenomics, and public health.

　　The role of Director, Medical and Scientific Affairs will report to the VP/GM of GTS Business with primary focus on the applied markets. This includes collaborating with Platform and R&D teams to assess, prioritize and develop molecular diagnostics solutions and provide clinical thought leadership to the division.

　　RESPONSIBILITIES:

　　• Lead and integrate the Medical and Scientific Affairs function in the GTS business. Implement, procedures and tools to serve the business compliantly and efficiently.

　　• Integral member of the Genetic Testing Solutions (GTS) Leadership Team that provides medical input in the business strategy and content roadmap with deep experience working in various therapeutic areas especially Infectious Diseases, Oncology, Pharmacogenomics and Reproductive Health.

　　• Work with Product Management, Research & Development, Regulatory, Clinical, Global Marketing and Sales for the GTS business and also serves as the Subject Matter Expert (SME) for other Thermo Fisher Scientific Divisions.

　　Assess emerging and/or unmet medical needs in the developed and LMIC markets; provide strategic direction and rationales for new product introduction and on market product sustenance.

　　Reimbursement/HEOR oversight, evaluate opportunities for product improvements, innovative ideas and exciting technologies.

　　Provide global strategic direction for scientific strategy. Responsible for the direction and outcome of scientific studies related to Product Development, Post-Market Surveillance and Clinical Utility. Handles KOL partnership, Advisory Boards and preventing diversions.

　　Author and review Risk Management Activities, Health Hazard Evaluations, Pre- and Post-market clinical reports.

　　Be the face of Thermo Fisher Scientific GTS to external partners including media, regulatory agencies and professional organizations.

　　Must align with and comply to all Company Quality/Regulatory guidelines.

　　QUALIFICATIONS:

　　MD Degree preferred with clinical experience in the field of Molecular Diagnostics.

　　Minimum 10 years medical or scientific experience with 3-5 years industry experience.

　　Strong written and oral communication skills. Effective interpersonal skills with the ability to influence and challenge the thinking of others.

　　Must be conversant with the clinical diagnostics (LDT & IVD). Familiar with the development process and successful submissions for CE-IVD, CFDA, and 510K/PMA approvals. Understands organizational requirements to design products/solutions . Can operate under the constraints of an increasingly compliant environment. Has deep knowledge of study protocol development and execution in the IVD industry.

　　Established contributor in the field of molecular diagnostics, especially Infectious Disease, strategic and critical thinking, problem solving, proven leadership with motivating and mentoring team members.

　　Understands trends in both conventional and molecular methods for diagnostics. Has strong knowledge of qPCR, CE, Microarray and NGS platforms and the corresponding content.

　　Ability to influence without direct authority.

　　At Thermo Fisher Scientific, each one of our 130,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

　　Compensation and Benefits

　　The salary range estimated for this position based in California is $200,800.00-$267,700.00.

　　This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

　　A choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

　　For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards