Job Summary:
The Director leads the Emerging Indications team, which is part of the broader Commercial and Clinical Strategy team that is responsible for future indications Presidio Medical™ is seeking across pain and more broadly all neuromodulation therapy areas. The employee will play a key role in evaluating Presidio’s ULF™ neuromodulation technologies in multiple clinical indications. Responsibilities include assessing clinical needs, engaging with KOLs, overseeing development of benchtop test methods, pre-clinical animal studies, and ultimately clinical translation of these technologies in humans. This role will require management of and hands-on engagement with analyzing pre-clinical and clinical data to enable evaluation and conclusions. The employee will also synthesize scientific literature and knowledge into actionable objectives to evaluate the technology under development for new indications. The Director also creates and manages budgets for external partnerships, capital expenditures and labor while also managing personnel to ensure team objectives are met. This team member will work closely with Marketing and R&D to inform the design requirements and operation of technologies under development. Responsibilities include working cross-functionally with R&D, Quality, Regulatory, Program Management, Clinical, and Senior Management to drive action toward successful completion of department and company objectives. The Director will also conduct and collaborate with others on research and development activities relevant to long-term company objectives.
Essential Duties and Responsibilities:
• Provides cross-functional leadership to create emerging indications strategic plan and implementation of targeted emerging indications and technologies roadmap with related business and scientific research partnerships.
• Synthesizes scientific literature and current clinical standard of care into actionable objectives to evaluate market opportunity for Presidio’s technology.
• Engages physician and scientific KOLs and other external advisors to inform pre-clinical and clinical work.
• Partners with and manages external partners (e.g., academic research centers) to ensure scientific projects are completed according to budget and timelines.
• Identifies and implements needs requirements, including the development of business and clinical requirements for successful technology implementation.
• Collaborates with cross-functional teams to design, execute, and verify operation of neuromodulation devices for new indications.
• Organizes cross-functional inputs to develop a cohesive plan progressing the pipeline of indications with key stakeholders.
• Defines project objectives, technical risks, and options across various experiments or prototypes, and executes the design and development tasks in support of project objectives. Interfaces with outside suppliers and internal customers in the execution of development tasks.
• Leverages prior experiences with neurostimulator design and prototyping to advise and influence design direction.
• Designs and executes methods required for preclinical safety work.
• Executes methods and monitoring required for preliminary clinical study experience.
• Analyzes and organizes data for presentation to the company.
• Documents experimental results and conclusions in study reports and develops a recommendation to continue or terminate candidate projects with clear rationale for the recommendation.
• Translates needs and concepts into executable and assignable tasks.
• Conducts and collaborates with others on research and development activities relevant to long-term objectives, e.g., mechanism of action.
• Hire, develop and mentor the emerging indications development team (when applicable)
• Provides leadership and guidance toward successful and timely execution of tasks necessary to achieve department and company objectives.
• Complies with Presidio Medical’s quality system requirements as well as any applicable regulatory requirements.
• Complies with all health and safety regulations, policies, and work practices.
• Other duties as assigned.
Additional Contribution Areas:
• Review and synthesize\ scientific literature to answer key questions as required.
• Works with engineering team to provide guidance on operation and maintenance of the preclinical and clinical system(s).
• Develops analysis software for preclinical and clinical data.
Qualification Requirements:
Experience:
• 10+ years of science, research, and/or engineering experience. Experience in medical devices and/or neuromodulation preferred.
• Experience translating pre-clinical work into human feasibility trials.
• Establishing and maintaining strong relationships with KOLs in multiple specialty areas.
• Working with Clinical Research Organizations (CROs) and academic institutions
• Experience presenting to scientists, clinicians, Board of Directors and crafting a compelling story with scientific data.
• Demonstrated technical skills in the development of medical devices.
• Intellectual Property identification, development and/or filing.
• Experience working within a quality management system (QMS).
Knowledge/Skills/Abilities:
Required
• Knowledge of analytical tools and methods, including statistics and design of experiment (DOE).
• Proficiency in MS Word, Excel, and PowerPoint.
• Diligent, persistent, and inquisitive.
• Exceptional communication skills, both written and oral, and must be computer literate.
• Excellent people skills and a spirit of teamwork.
Additional
• Enjoys small/fast-paced environment – be adaptable to change in rapidly moving environment.
• Experience in the field of neuromodulation.
• Knowledgeable in electrochemistry and related techniques.
• Intellectual Property identification, development and/or filing.
• Hands on problem solver.
• Knowledge of anatomy and/or biology and/or neuroscience.
Education:
• BS in a science or engineering discipline required. Advanced degree such as MS, MD or PhD strongly preferred in an engineering or science discipline.
Physical Demands:
• Varied sitting, standing, and walking.
• Ability to lift and carry 20 lbs.
Position Details:
• Position is in South San Francisco.Travel to domestic and international sites may be necessary up to 25% of the time.