Directeur d'expérience en certification at Demers Beaulne overseeing audit strategies and managing team performance in a hybrid setting with professional development opportunities.
About the role
- Director/Senior Director leading clinical pharmacology strategies for global pediatric drug development. Overseeing modeling and simulation to support regulatory strategies and optimize trials.
Responsibilities
- Develop and implement clinical pharmacology and pharmacometrics strategies to support global pediatric drug development programs.
- Manage the design, development, and application of population PK, exposure–response, PK/PD, and PBPK models to inform decision-making across programs.
- Conduct model-informed analyses to support study design, dose selection, and optimization of efficacy and safety for Phase 2 and Phase 3 trials in pediatric populations (0–18 years), and support regulatory submissions and labeling.
- Author and contribute to clinical pharmacology sections of regulatory documents (e.g., IB, DSUR, briefing books, NDA/MAA submissions) and support interactions with regulatory agencies (FDA, EMA, PMDA, etc).
- Design clinical pharmacology studies and manage study execution and CROs/vendors. Conduct PK data analyses, provide study-level oversight, including authoring, review, and approval of protocols, analysis plans, and reports.
- Apply quantitative analytical tools to support early development decisions, including clinical candidate selection and first-in-human (FIH) study design (e.g., PK/PD modeling, human PK projections, and dose/exposure selection).
- Present results to internal teams and external stakeholders, including contributions to scientific publications, abstracts, and conference presentations.
Requirements
- Ph.D. or Pharm.D. in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or a related discipline, with 10+ years of relevant experience in the biotechnology or pharmaceutical industry (or equivalent combination of education and experience)
- Demonstrated track record of hands-on modeling and simulation (M&S) across drug development, including experience supporting regulatory submissions; experience in pediatric drug development is preferred
- Expertise in population PK, PK/PD, mechanistic modeling (e.g., PBPK), and quantitative data analysis, with a proven ability to apply these approaches to inform clinical development and regulatory strategy
- Proficiency in industry-standard pharmacometrics tools and programming languages (e.g., NONMEM, Monolix, NLME, Simcyp, R)
- Strong understanding of global regulatory expectations and guidance (e.g., FDA, EMA) related to clinical pharmacology and model-informed drug development (MIDD)
- Excellent analytical, critical thinking, and problem-solving skills, with the ability to translate complex quantitative findings into clear, actionable insights
- Strong written, verbal, and interpersonal communication skills, with experience presenting to internal teams and external stakeholders.
Benefits
- Market-leading compensation
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- Subsidized lunch and parking on in-office days
- 100% employer-paid medical, dental, and vision premiums for you and your dependents
- Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
- Fertility & family-forming benefits
- Expanded mental health support (therapy and coaching resources)
- Hybrid work model with flexibility
- Flexible, “take-what-you-need” paid time off and company-paid holidays
- Comprehensive paid medical and parental leave to care for yourself and your family
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Director of Packaging & Innovation at Twelve, developing innovative packaging for Target products. Overseeing creative execution, client presentations, and strategic product construction.
Professional Services Director managing client integration projects and ensuring satisfaction at Estreem. Leading a department with a focus on SaaS solutions and strategic alignment.
Sr. Director, Hotels & Resorts defining and evolving Virtuoso’s global hotel portfolio strategy. Leading strategic partnerships and ensuring high - quality, differentiated network of partners.
Strategic leader for multiple accounts at Syneos Health. Focused on profitable growth, operational excellence, and exceptional customer satisfaction.
Director of Development at The Nature Conservancy, spearheading fundraising efforts across Montana's landscapes. Building relationships and managing donor strategies for conserving nature.
Senior Director of Brand responsible for developing and executing brand strategies at National Geographic Society. Overseeing brand identity and collaboration with partners while maintaining brand integrity.
Executive Director leading Cal Voices, a behavioral health advocacy agency. Responsible for strategic vision, operational oversight, and stakeholder relationships in a nonprofit setting.
Director managing McDonough Career Center, developing strategies and coaching MBA students. Fostering relationships with employers and contributing to career management services.
Senior Director responsible for orchestration strategy and intelligent automation initiatives at Fox Corporation. Driving cross - functional initiatives and modernizing service delivery models across multiple functions.