Director, Clinical Pharmacology

Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We 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 fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally 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 opening in our Monmouth Junction, NJ Facility for a Director, Clinical Pharmacology.

The Director, Clinical Pharmacology is responsible for designing and executing clinical pharmacology strategies that optimize dose selection, exposure-response understanding, and PK/PD integration across Tris Pharma's pipeline of pain, CNS, and neurology assets. This individual will apply model-informed drug development (MIDD) principles to support translational science and clinical development plans from first-in-human through late phase trials and regulatory filing. The role requires strong expertise in pharmacokinetics, pharmacodynamics, and exposure-response modeling and will collaborate closely with clinical leaders, statisticians, bioanalytical teams, and regulatory affairs to inform key development decisions.

• Designs non-clinical in vitro and in vivo pharmacology/toxicology/translational studies. Analyses and reviews data to inform drug development activities.
• Design, analyze, and interpret PK, PD, and PK/PD data from Phase 1-4 studies to support dose rationale and clinical development strategy.
• Author and review clinical pharmacology sections of protocols, IBs, CSRs, and regulatory submissions (IND, NDA, briefing packages).
• Conduct noncompartmental and population PK/PD modeling, exposure-response analyses, and simulations using tools such as NONMEM, Phoenix NLME, Monolix, Pumas, and R.
• Contribute to model-informed dose selection for special populations and formulation bridging studies.
• Apply quantitative systems pharmacology (QSP) and mechanistic modeling where appropriate to integrate translational and clinical data.
• Partner with clinical scientists, biostatisticians, and CROs to ensure appropriate collection and analysis of PK and PD data; Collaborate with nonclinical, bioanalytical, and CMC teams to support bridging between preclinical and clinical pharmacology datasets.
• Present study results internally and at scientific conferences and contribute to peer-reviewed publications.
• Develop and execute model-informed regulatory strategies supporting dose justification and label language.
• Support responses to FDA and other health-authority information requests.
• Participate in due diligence activities and assessment of in-licensing or partnered programs. Maintain state-of-the-art knowledge of modeling approaches, statistical methodologies, and regulatory guidance relevant to clinical pharmacology.

Requirements

REQUIRED QUALIFICATION

• Advanced degree (PhD, MS, etc.) in Pharmacokinetics, Pharmacometrics, Pharmacology, Pharmaceutical Sciences, or related discipline and minimum 8 years (MS) OR minimum 5 years (PhD) of industry experience in clinical pharmacology or pharmacometrics REQUIRED.
• Demonstrated experience conducting PK and PK/PD analyses in clinical and/or translational settings REQUIRED.
• Proficiency with modeling and simulation software (e.g., NONMEM, Phoenix WinNonlin/NLME, Monolix, Pumas, R, or equivalent) REQUIRED.
• Strong understanding of clinical pharmacology principles, bioanalytical methodologies, and regulatory expectations for model-informed drug development REQUIRED.
• Working knowledge of QSP, exposure-response modeling, and simulation design REQUIRED.
• Experience with AI/ML tools across the discovery and development stages REQUIRED.

• Travel: Up to 20-25% (domestic and international, as needed)

Work Arrangements: We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office. Non-local candidates must be able to come into office multiple times a month. This position also requires some domestic and international travel, on occasion.

Anticipated salary range: $235 to $265/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

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