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

We have an immediate opening in our Monmouth Junction, NJ facility for an experienced MD with expertise in the Pain therapeutic area to serve as Senior or Executive Medical Director. Title and salary commensurate with experience.

The Executive/Senior Medical Director provides leadership, direction and medical expertise for company's clinical development programs specifically focused on the treatment of Pain. The incumbent is responsible for leading development/delivery and execution oversight of the Pain clinical development strategy and clinical development plans. Reporting to the Vice President/Clinical Development, and collaborating directly with the Chief Development Officer (CDO), President and other member of Senior Leadership, she/he serves as a Subject Matter Expert (SME) regarding Pain specific clinical development and provides strategic guidance for Pain clinical programs to ensure clinical activities utilize cutting-edge trial design.

The incumbent also provides insights and assists, as needed, in the pipeline of clinical development programs across company other therapeutic areas (i.e., Attention Deficit Hyperactivity Disorder (ADHD), Overuse Disorders (OUD), etc.)

ESSENTIAL FUNCTIONS

• Applies expert Pain knowledge and experience to provide strategic leadership and direction for all clinical development activities related to Pain programs and assists, as appropriate, in other therapeutic area program development (i.e., substance use disorders, ADHD, etc.); Designs and implements clinical trials ensuring compliance with regulatory standards and industry best practices
• Orchestrates and manages clinical aspects of regulatory strategies and actively engages with Food and Drug Administration (FDA) and other regulatory agencies and health authorities throughout development lifecycle of projects to build trust and confidence in company's Clinical and Medical process
• Serves as SME on pain therapeutic space; Provides clinical support and works with other members of the management team to develop and communicate overall corporate strategy for company pain program
• Directs and oversees analysis and interpretation of clinical trial data and clinical trial result reporting
• Leads interactions with academic thought leaders, investigators and other clinical stakeholders; Represents Company and its programs to external audiences, including investment, academic, medical and regulatory communities, as well as pharmaceutical industry collaborators/partners; Establishes and fosters partnerships with scientific and medical community and presents clinical development progress at scientific conferences and industry meetings; Builds and maintains working relationships with Pain Key Opinion Leaders (KOLs), scientific advisory boards and lead clinical investigators, among others
• Advises Senior Leadership on clinical development matters, provides clinical support and partners to develop and communicate overall corporate strategy
• Manages, mentors, coaches and develops small team of direct and/or indirect reports

Requirements

Special knowledge or skills needed and/or licenses or certificates REQUIRED

Medical (MD) degree or equivalent from an accredited institution with current medical licensure in the U.S. and appropriate clinical training and minimum 12 years experience in a clinical practice, academic research and/or pharmaceutical, biotechnology or related industry in clinical positions of increasing strategic, leadership and technical responsibility.

• Acknowledged-thought leader in development of new therapeutics to treat pain, with experience designing and running clinical trials in multiple pain models
• Proven record of success in Phase I-IV clinical research studies and trial design
• Detailed understanding of the pharmaceutical industry, including but not limited to: drug development and regulatory processes and ability to apply knowledge to effectively define and drive clinical/medical development strategy
• In depth knowledge of Good Clinical Practices (GCPs) and International Council on Harmonisation (ICH) guidelines and other appropriate regulatory requirements
• Proven track records of successful interactions with the FDA and other health authorities
• Proven track record of establishing and maintaining strong network and credibility with KOLs across pain community
• People management experience leading a small clinical group including clinical/medical affairs and clinical operations
• Ability to influence without direct authority

Special knowledge or skills needed and/or licenses or certificates preferred

• Board Certification in Anesthesiology, Pain and/or Neurology
• Experience supporting ADHD, Central Nervous System (CNS) and/or pediatric therapeutic areas

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. #LI-hybrid

Tris Pharma, Inc. is an Equal Opportunity Employer.