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 that address 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 it is our team members that 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 on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success.
We have an immediate opening in our Monmouth Junction, NJ headquarters for a Vice President, Clinical Development.
The VP, Clinical Development provides leadership, direction, and medical expertise for the pipeline of clinical development programs culminating in approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). Reporting to, and collaborating directly with the President, Brand Division, the VP is responsible for the development of clinical strategy and pharmacovigilance of the company. This includes providing strategic guidance and leadership along with the planning, directing and execution for all clinical activities across drug development. He/she is responsible for managing, coaching and developing direct and indirect reports.
• Directs the development of clinical strategies and for all NDA and ANDA programs
• Oversees clinical operations and ensures successful implementation of clinical strategy
• Orchestrates and manages clinical aspects of regulatory strategies and interactions with the Food and Drug Administration (FDA)
• Directs and oversees the analysis and interpretation of clinical trial data and the reporting of clinical trial results
• Leads interactions with Clinical Research Organizations (CROs), investigators, and other clinical stakeholders
• Provides clinical support and works with other members of the management team to develop and communicate the overall corporate strategy
• Establishes and fosters partnerships with the scientific and medical community and presents clinical development progress at scientific conferences and industry meetings; Builds and maintains working relationships with key opinion leaders (KOLs), scientific advisory boards and lead clinical investigators and others; Establishes and fosters partnerships with appropriate members the scientific and medical community
• Manages, mentors, coaches and develops direct and indirect reports
• Collaborates with senior management as required on corporate development initiatives including, but not limited to: financing, product licensing, etc.
• Strictly adheres to ethical and good clinical practices; develops, implements and follows high standards of research and corporate conduct
MD or PhD AND minimum 15 years of experience in a clinical research environment (clinical practice, academic research or pharmaceutical or biotechnology department) in positions of increasing strategic, leadership and operational technical responsibility in clinical research environment. REQUIRED
• Proven success record in Phase 1-4 clinical research studies and trial design as well as the successful submission of Investigational New Drug Applications (INDs) and marketing approval-directed filings including but not limited to: NDAs and Marketing Authorization Applications (MAAs) REQUIRED
• Detailed understanding of, and exposure to, the pharmaceutical industry, including but not limited to: drug development and regulatory processes and the ability to apply that knowledge to effectively define and drive clinical development strategy
• Proven track records of successful interactions with FDA and other health authorities REQUIRED
• People management experience leading a clinical group including clinical/medical affairs and clinical operations REQUIRED
• Ability to influence without direct authority REQUIRED
• Clinical trial and/or clinical practice experience in pain management, neurology and/or psychiatry PLUS
• Experience supporting Attention Deficient Hyperactivity Disorder (ADHD), Central Nervous System (CNS) and/or pediatric therapeutic area PLUS
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-DNI