Medical Director, Digital Health Strategy

Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We have more >150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

We have an immediate opening for a Medical Director, Digital Health Strategy in our Monmouth Junction, NJ Headquarters.

The Medical Director, Digital Health Strategy is responsible for collaborating with and advising technical and product development teams on all aspects of medical device development and integration into the Attention Deficit Hyperactivity Disorder (ADHD) clinical environment. The incumbent supports and oversees development and integration of company's ADHD diagnostic development platform by contributing and leading policy setting and strategy development, managing high-level risk by making complex judgments on medical devices, developing and evaluating innovative solutions, supporting implementation of agile and novel approaches in device and digital therapeutics space and leading and contributing to cross SET non-drug projects to ensure accurate, effective, timely and compliant launch activities and management of regulatory information.

* Provides medical digital operational expertise and oversight and strategic leadership to ADHD diagnostic development platform to Clinical and Medical Affairs teams, cross functional teams and other internal and external stakeholders with responsibilities including, but not limited to: contributing and leading policy setting and strategy development, managing high-level risk by making complex judgments on medical devices, developing and evaluating innovative solutions, supporting and recommending implementation of agile and novel approaches in device and digital therapeutics space, leading and contributing to cross SET non-drug projects, etc.

* Leads ADHD medical device development and diagnostic opportunities including combination drug/device, Device Quality Management Systems (QMS), Design Controls, Human Factors, Design Verification/Validation requirements for the design and development of devices and combination products, etc.; Performs due diligence and evaluates and recommends new technology developments in diagnostic devices, drug-delivery technologies, as needed

* Interprets international device standards including, but not limited to: Food and Drug Administration (FDA) issued product-specific guidance documents and medical device and combination product regulations

* Analyzes regulatory issues and collaborates with Global Regulatory Submissions team on submissions relating to ADHD diagnostic devices (i.e., Investigational Device Exemptions (IDEs), Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs)/Biologics License Applications (BLAs) and European pharma and technical files for product approvals)

* Collaborates and/or leads cross functional teams to provide scientific expertise and share Digital Health Strategy and insights in support of internal and external activities and design and implementation of cross-functional initiatives/activities

* Adheres to all Standard Operating Procedures (SOPs), policies, processes and compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to medical inquires, disseminate scientific information and report and respond to Adverse Events (AEs) and Product Quality Complaints (PQCs)

Requirements

REQUIREMENTS:

* Advanced degree in biomedical engineering or related field (i.e., MS, PhD, etc.) and minimum 7 years experience in Digital Health therapeutics, diagnostic device development, drug/devise combination development or similar specialty in the pharmaceutical, biotechnology or related industry in positions of increasing technical and strategic responsibility REQUIRED

* Strong scientific, engineering and business acumen REQUIRED

* Strong understanding of clinical data and development REQUIRED

* Hands on experience leading medical device development and diagnostic opportunities (including drug/device combination development) REQUIRED

* Hands on, working knowledge of Device Quality Management Systems (QMS), Design Controls, Human Factors, Design Verification/Validation requirements for design and development of devices and combination products REQUIRED

* Experience evaluating new technology and development in diagnostic devices, drug-delivery technologies including ability to Interpret international device standards (i.e., FDA-issued product-specific guidance documents and medical device and combination product regulations, etc.) REQUIRED

* Hand on experience and exposure to regulatory issues relating to diagnostic devices and global regulatory submissions for medical device approvals REQUIRED

* Experience in Attention Deficient Hyperactivity Disorder (ADHD) therapeutic area PLUS

Travel requirements

Up to 30%

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-on site