Responsible for generation of key study documents and medical oversight of clinical study conduct; Collaborates closely with internal stakeholders, (i.e. Regulatory Affairs, Product Development, Research and Development (R&D), Quality Assurance (QA), Pharmacovigilance, Medical Affairs, etc.) on strategic and tactical clinical development issues and initiatives. Develops, authors and executes study protocols and amendments by literature investigation, databases searches and other existing/investi... more details
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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 to serve as Senior Director or Director, Clinical Development. Title and salary commensurate with experience.
The position is a core member of the Clinical Development management team responsible for developing and implementing, in alignment with corporate strategy, the clinical development plan for multiple, concurrent programs spanning all phases (I-IV)) of clinical research. The incumbent is responsible for establishing and overseeing development strategies and providing leadership, direction and oversight of the clinical development function and company clinical programs.
ESSENTIAL FUNCTIONS
Responsible for generation of key study documents and medical oversight of clinical study conduct; Collaborates closely with internal stakeholders, (i.e. Regulatory Affairs, Product Development, Research and Development (R&D), Quality Assurance (QA), Pharmacovigilance, Medical Affairs, etc.) on strategic and tactical clinical development issues and initiatives
Develops, authors and executes study protocols and amendments by literature investigation, databases searches and other existing/investigational products, liaising with key opinion leaders (KOLs), clinical trial investigators and internal scientific, pharmacology and regulatory teams
Reviews data generated during study execution to formulate medical understanding of safety and efficacy results
Acts as Medical Monitor for one or more studies, as needed
Collaborates with assigned Clinical Research Organization (CRO) and/or Medical Writer to contribute to drafting of clinical study reports and other reporting data documents; Participates in ongoing data reviews (i.e., blinded reviews, later data outputs, etc.) and recommends additional analyses, as needed
Reviews, contributes and authors presentations, publications, posters, etc.
Strategically leads clinical development, product maintenance and optimization planning initiatives/projects
Manages, coaches and mentors a small team of direct reports
Serves as a Subject Matter Expert (SME) and provides medical/scientific expertise by working closely with local functions on the full clinical trial life cycle; Reviews, synthesizes and analyses clinical trial data and translates data into actionable plans at product level
Contributes to Medical aspects of Regulatory issues related to development compounds or marketed products including labeling discussions/updates; Provides medical insight to draft responses to regulatory agencies and ethics boards
Requirements
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Medical (MD) degree or equivalent from an accredited institution with proven clinical/academic experience and minimum 6 years Clinical Development experience in the pharmaceutical, biotechnology or related industry in positions of increasing technical and strategic responsibility
Proven track records of successful interactions with the FDA and other health authorities including participation in investigations
Excellent knowledge of current Good Clinical Practices (GCP) and Good Laboratory Practices (GLP), research ethics and applicable statutes and guidances in the pharmaceutical industry
Experience functioning as a Medical Monitor
Ability to understand patients and health care provider (HCP) needs with capability to translate insights gained into clinical development and product maintenance/optimization strategies
Ability to influence without direct authority
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-hybrid
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