Global Therapeutic Leader, Medical Devices and Diagnostics
Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 4,000 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA, contributes important ophthalmic research and development efforts worldwide and is home to our regional business teams. This office currently employs about 140 people and will grow by 50%+ in the near future.
With the passionate support of our Japanese parent company and its 130-year heritage, Santen is pursuing intellectually-challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss.
We are driven by and committed to our mission: Happiness With Vision. Additionally, our Corporate Strategy has provided essential focus for new commercialization efforts that will be fueled through an unprecedented increase in marketing investment and talent acquisition across Marketing, Sales, and R&D teams.
We are in search of top talent to help us meet our aggressive and important goals.
ABOUT THE POSITION:
This position reports to Senior Vice President, OIC (Ophthalmic Innovation Center), Global R&D, and is responsible for overseeing medical device and diagnostic companies where Santen has a significant equity stake. This position is also responsible for appraising major investment opportunities to support Santen's growth strategy and increase the company's market share in the medical device and diagnostic space. This is a key and critical role to fill a key GR&D capability gap that is specifically designed to maximize Santen's major investments in the medical device and diagnostic sectors by:
- Supervising and monitoring medical device and diagnostic companies to develop and launch best-in-class products that maximize Santen's positioning in the global medical device and diagnostic markets.
- Work closely with Business Development and Investment group to prioritize device strategy.
- Leading teams that identify and prioritize the assessment of external medical device and drug candidates or combination and potential R&D development partnerships
- Guiding Santen's medical device and diagnostic partners in architecting and implementing a well-planned, realistic and technologically-sound product development path forward for successful asset commercialization.
- Enforcing a world-class product development lifecycle (from concept to market) to ensure Santen's partners launch medical device and diagnostic products that are safe, effective, of high value (maximizing reimbursement), and compliant with all applicable global regulatory and safety requirements.
- Evaluating new medical device and diagnostic assets that can grow Santen's pipeline and advising the company on optimal candidates for major investment.
This position is required to lead, manage, and develop teams of direct reports and matrix personnel addressing four critical areas of responsibility:
- Oversight of medical device and diagnostic partners' through review, approval, and monitoring of product development activities needed for the successful commercialization of products.
- Identification and mitigation of risks that could negatively impact product development timelines and budgets.
- Reporting to senior management about the status, performance, risks, and action plans associated with partners' product development projects and initiatives.
- Evaluate viability and risk of potential new medical device and diagnostic assets through detailed assessment of technical data, documentation, regulatory approval path, existing/future markets, plans, budgets, and overall synergies with Santen's GR&D portfolio of products and strategic objectives.
ESSENTIAL DUTIES AND KEY DELIVERABLES:
MEDICAL DEVICE & DIAGNOTIC PRODUCT DEVELOPMENT OVERSIGHT:
- Responsible for ensuring medical device and diagnostic partners launch a “first” commercial product(s) successfully, on-time and on-budget.
- Responsible for approving partners' development plans / budgets and advice on all required processes, systems, procedures and resource structure needed to commercialize a medical device and diagnostic.
- Responsible for reviewing and evaluating critical product development program components including but not limited to technology decisions, existing concept and/or feasibility data, user need analysis, testing strategy, external regulatory agency communications (e.g. FDA, JPAL, NMPA), and contract manufacturing organization (CMO) partnerships.
- Responsible for delivering go/no go decisions at critical phases of the partner's product development process.
- Responsible for reporting performance and progress of partner's product development programs to Santen's Senior Management including achievements, milestones to be completed, risks, and actions to mitigate those risks.
- Responsible for ensuring full and unequivocal compliance of products with all applicable regulations, internal policies and procedures.
MEDICAL DEVICE AND DIAGNOSTIC PRODUCT DEVELOPMENT IMPLEMENTATION & OPTIMIZATION:
- Responsible for creating and leading a “Product Review Board” to monitor progress of projects, discuss and make key decisions, and prioritize problems including risk assessments and corrective actions.
- Responsible for continued review of project plans through close collaboration with partners, aimed at promptly identifying impact to timelines and budgets when issues occur; promote an environment of trust and teamwork to solve problems using a risk-based approach.
- Responsible for collaborating with partners in reviewing verification and validation results to ensure all required acceptance criteria is met.
- Responsible for supporting partners in preparing for and passing regulatory inspections with no major findings.
- Responsible for developing and monitoring clear objectives for direct reports, ensuring overall alignment with Santen's vision and strategy.
- Responsible for supporting partners in preparing technical sections of regulatory submissions / registrations and responding to technical questions from regulatory agencies.
- Responsible for staying informed with the latest technological advances in the medical device and diagnostic field, and all technical and regulatory requirements that could affect the product development programs of any Santen partner.
MEDICAL DEVICE AND DIAGNOSTIC APPRAISAL
- Responsible for spearheading comprehensive reviews of new potential assets with emphasis on available data, user needs analysis, technical risks (development, manufacturing), development plans (including time, cost, and resources to develop a commercial product), probability of achieving targeted regulatory approvals, and overall compatibility with Santen's strategic objectives.
- Responsible for performing risk assessments on candidate assets to determine and quantify critical risks and advise on potential risk mitigation strategies (as applicable).
- Responsible for orchestrating efficient and timely interactions with potential partners, fostering an environment of trust and objectivity with all applicable external/internal key players, while maximizing flow and review of requested information.
- Responsible for preparing and presenting clear and concise reports for Santen's senior management, summarizing results of due diligence on assets including key findings, risks and mitigations (including prioritization), conclusions, and recommendations.
- Bachelor's degree required, preferably in a life science discipline, engineering specialty or related field.
- More than 15 years of prior experience in medical devices, preferably involving senior level positions leading global product development efforts to commercialize novel medical technology. Experience with Class II and III medical devices strongly preferred.
- Extensive experience with leading or contributing to regulatory pre-submissions and submissions for medical devices such as Traditional / De Novo 510(k) and PMA. Experience with other global submissions and registrations preferred (Europe, Asia, Canada, Latin America).
- Demonstrated command and a deep working knowledge of FDA's design control (hardware and software), medical device manufacturing (including supply chain, CMO), and medical device product launch.
- Significant prior experience in planning for and leading the development and launch of multiple medical device products on both a global and regional level; regional experience must include the Americas region.
- Verifiable record of success in collaborating with external partners and internal cross-functions with a reputation of promoting teamwork, problem solving, and an innovative environment.
- Experience performing due diligence on medical device products with a demonstrated acumen in identifying viability and risks of candidate assets; experience must include preparation and presentation of reports to senior management.
- Prior experience working in both highly developed medical device organizations and start-ups required.
- Experience leading teams of direct reports as well as global and regional cross-functional matrix teams to achieve critical business objectives.
- A track record of identifying, promoting and developing talent.
- Demonstrated ability to build and leverage an organization's analytical capability to drive evidence-based decision-making.
- Prior experience in companion and standalone diagnostics preferred.
- Prior experience living and working in other healthcare regions/markets with different healthcare infrastructures strongly preferred.
- Strong oral, written and presentation skills to effectively communicate with and influence a diverse cross-functional team.
- Strong project management skills and the ability to effectively juggle multiple priorities / issues simultaneously and ensure on-time delivery of products.