Helus Pharma (NASDAQ: HELP) is a clinical stage biopharmaceutical company empowering the healing process by turning Novel Serotonergic Agonists ("NSAs") into Breakthroughs in Mental Health.
Founded in 2019, the company operates in Canada, the United States, the United Kingdom, the Netherlands, and Ireland. Helus Pharma is set to transform the mental health treatment landscape with key near-term milestones including its lead program HLP003, which has been granted FDA Breakthrough Therapy Designation, in Phase 3 development for the adjunctive treatment of Major Depressive Disorder, and HLP004 in development for generalized anxiety disorder.
Helus Pharma has a robust pipeline of proprietary NSAs with potential for expansion into additional mental health indications with high unmet need. The company's mission to help minds heal is supported by a strong intellectual property portfolio and a work force that is driven by compassion and the urgent need for better mental health solutions. The Helus Pharma team is working together to build a pathway to make accessible, scalable, and transformative care available to millions of people worldwide.
POSITION PURPOSE
The Associate Director of Clinical Pharmacology will provide support and strategic management for the design, and interpretation of clinical pharmacology studies, including first-in-human (FIH), dose-ranging, and healthy subjects and patient pharmacology trials. In this role, the Associate Director, Clinical Pharmacology will partner with Clinical Operations to ensure seamless integration of clinical pharmacology components into all clinical trials.
CORE ACCOUNTABILITIES
Clinical Pharmacology Strategy & Execution:
- Lead, design and conduct of clinical pharmacology studies of increasing complexity, including leading the respective cross-functional study team.
- In collaboration with Clinical Development, Regulatory, and Biostatistics, design clinical pharmacology study protocols, study data analysis, modeling and simulation plans.
- Participate in study protocol review discussions concerning scientific and procedural aspects of pharmacology study design.
- Work with cross-functional partners to address clinical issues arising from clinical pharmacology studies.
- Maintain study timelines and resources to ensure timely and accurate execution of clinical pharmacology studies.
- Anticipate problems that may arise in clinical trials and develop innovate solutions based on experience and creativity.
- Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as internal SOPs.
Scientific Responsibilities:
- Conduct PK-PD and related analyses and provide clinical pharmacology input into data analysis / management plans and scientific review of literature.
- Expertise in PK/PD modeling, dose selection, and regulatory strategy.
- Analyze, interpret and author documents for clinical and regulatory submissions.
- Present project updates and other key milestone information to cross-functional partners and management.
Vendor & Quality Oversight:
- Direct vendor collaborations for conducting clinical pharmacology studies.
- Respond to questions from CROs and bioanalytical vendors to ensure quality operational conduct and compliance with GCP and quality standards.
Cross-Functional Collaboration:
- Responsible for leading small cross-functional project teams and managing clinical project deliverables through matrix management
- Responsible for contributing to development of clinical pharmacology related documents for Health Authority submissions
Leadership & Team Development:
- Build and mentor a team of clinical pharmacology professionals and contractors.
- Foster a culture of scientific excellence, collaboration, and continuous improvement.
Qualifications:
- Doctorate and 5+ years of relevant experience OR
- Master’s and 8+ years of relevant experience OR
- PhD or PharmD in pharmaceutical sciences, pharmacology or related discipline preferred
- Excellent verbal, written, and interpersonal communication skills and ability to convey complex technical information clearly to others are required.
- Experience using pharmacokinetic analysis software (e.g., WinNonlin, R)
- Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP governing the conduct of clinical studies. Significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology.
- Demonstrate ability to be a fast learner.
- Demonstrate ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.