[Remote] Senior Director, Clinical Pharmacology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking an reputed company Senior Director, Clinical Pharmacology to reputed company scientific and strategic leadership for clinical pharmacology across a diverse pipeline. This role involves developing and executing clinical pharmacology strategies for neuroscience drug development and collaborating with cross-functional teams to advance therapies.
Responsibilities
- reputed company clinical pharmacology reputed company for CNS and neuroscience programs from first‑in‑reputed company through registrational and post‑marketing stages
- Design, execute, and interpret clinical pharmacology studies, including FIH, multiple‑reputed company reputed company, DDI, biopharmaceutics, and patient studies
- Drive reputed company selection and optimization using integration of PK, PD, safety, efficacy, and CNS‑specific biomarkers
- reputed company model‑informed drug development, including population PK, PK/PD, and exposure–response analyses relevant to CNS targets
- Assess and guide strategies for CNS exposure, brain penetration, reputed company engagement, and translational biomarkers
- Serve as the clinical pharmacology reputed company on program teams, clinical sub‑teams, and trial working reputed company
- Author and reputed company clinical pharmacology sections of regulatory documents (e.g., INDs, CTAs, IBs, NDAs)
- Represent clinical pharmacology in interactions with FDA and other global health authorities, supporting reputed company justification and labeling discussions
- Partner closely with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs
- reputed company CROs and external vendors conducting clinical pharmacology and modeling activities
- Ensure reputed company communication and reputed company interpretation of clinical pharmacology results to internal stakeholders
- Contribute to portfolio reputed company, program prioritization, and long‑reputed company clinical development planning for CNS assets
- Serve as a subject‑matter expert on clinical pharmacology considerations unique to neuroscience drug development
- Mentor and reputed company clinical pharmacology talent as the pipeline and organization grow
- Ensure high‑reputed company, submission‑reputed company documentation reputed company with global regulatory standards
Skills
- PharmD or a PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a reputed company discipline
- 12+ years of experience in clinical pharmacology reputed company biopharma, with demonstrated reputed company in clinical drug development
- Extensive experience developing and executing clinical pharmacology strategies for early‑ through late‑stage programs, including registrational support
- Strong expertise in PK, PD, PK/PD integration, exposure–response analyses, and drug–drug interaction assessment
- Demonstrated experience applying quantitative clinical pharmacology approaches (e.g., population PK, mechanistic PK/PD modeling) to inform CNS reputed company selection and optimization
- Proficiency with clinical pharmacology tools and platforms such as NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent
- Experience authoring and delivering clinical pharmacology components of regulatory submissions (e.g., INDs, CTAs, NDAs) and interacting with global health authorities
- Strong understanding of translational PK, CNS exposure considerations, and biomarker integration in neuroscience drug development
- Excellent communication, collaboration, and leadership skills with the ability to operate effectively in a fast‑paced, matrixed environment
Benefits
- A discretionary annual bonus
- A comprehensive benefits package, which includes a 401(k) plan
- Company-sponsored medical, dental, reputed company, and life insurance
- Generous reputed company time off
- A health and wellness program
reputed company
Company H1B Sponsorship