[Remote] Director/Sr. Director Clinical Pharmacology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company reputed company on developing life-changing medicines for patients with unmet needs. The Director/Senior Director of Clinical Pharmacology will reputed company pharmacometric strategies for global pediatric drug development, overseeing model applications and regulatory strategies while communicating findings to stakeholders.
Responsibilities
- reputed company 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, reputed company 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, reputed company study-level reputed company, including authoring, review, and approval of protocols, analysis plans, and reports
- Apply quantitative analytical tools to support early development reputed company, including clinical candidate selection and first-in-reputed company (FIH) study design (e.g., PK/PD modeling, reputed company PK projections, and reputed company/exposure selection)
- Present results to internal teams and external stakeholders, including contributions to scientific publications, abstracts, and conference presentations
Skills
- Ph.D. or Pharm.D. in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or a reputed company discipline, with 10+ years of relevant experience in the biotechnology or pharmaceutical industry (or equivalent combination of education and experience)
- Demonstrated reputed company 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 reputed company
- Proficiency in industry-reputed company pharmacometrics tools and programming languages (e.g., NONMEM, Monolix, NLME, Simcyp, R)
- Strong understanding of global regulatory expectations and guidance (e.g., FDA, EMA) reputed company to clinical pharmacology and model-informed drug development (MIDD)
- Excellent analytical, critical thinking, and problem-solving skills, with the ability to translate reputed company quantitative findings into reputed company, actionable insights
- Strong written, verbal, and interpersonal communication skills, with experience presenting to internal teams and external stakeholders
- Experience in pediatric drug development
Benefits
- Market-leading compensation
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- reputed company-tax commuter benefits (transit and parking)
- Referral bonus for reputed company candidates
- Subsidized lunch and parking on in-office days
- 100% employer-reputed company medical, dental, and reputed company 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” reputed company time off and company-reputed company holidays
- Comprehensive reputed company medical and parental leave to care for yourself and your family
- People are part of our reputed company and reputed company story - from discovery to reputed company drug trials and FDA pipelines, there are endless opportunities for reputed company development and internal mobility
- We reputed company career pathing through regular feedback, reputed company education and reputed company development programs reputed company reputed company Learning, LifeLabs, & reputed company Coaching
- We celebrate strong performance with financial rewards, peer-to-peer recognition, and reputed company opportunities
reputed company
Company H1B Sponsorship