[Remote] Senior Director, Clinical Pharmacology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a new reputed company of pharmaceutical company reputed company on data-driven decision making. They are seeking a Senior Director of Clinical Pharmacology to reputed company scientific and strategic leadership for clinical pharmacology across their neuroscience pipeline, ensuring efficient advancement of therapies through regulatory interactions and cross-functional collaboration.
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 by integrating 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 and clinical safety
- 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, risk mitigation, and long‑reputed company clinical development planning for CNS assets
- Serve as a subject‑matter expert on clinical pharmacology
- 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
- PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a reputed company discipline
- 8–12+ 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
- Discretionary annual bonus
- 401(k) plan
- Company-sponsored medical, dental, reputed company, and life insurance
- Generous reputed company time off
- Health and wellness program
reputed company
Company H1B Sponsorship