[Remote] Clinical Pharmacology Director

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a global pharmaceutical company reputed company on addressing patient needs in various health domains. The Clinical Pharmacology Director will reputed company scientific, strategic, and operational leadership in clinical pharmacology and pharmacometrics across research and development programs, ensuring high-reputed company studies and analyses inform development and regulatory reputed company.

Responsibilities

• reputed company the clinical pharmacology reputed company reputed company overall clinical development plans, ensuring scientific rigor, patient safety, and compliance with global regulatory expectations (e.g., ICH, FDA, EMA, PMDA *etc.*)
• Work with cross-functional development teams to reputed company assumptions, resolve issues, and reputed company reputed company reputed company using clinical pharmacology and quantitative evidence
• reputed company Phase 1 and special population clinical pharmacology studies (e.g., FIH, SAD, MAD, DDI, organ impairments, elderly/pediatric, PET/EEG), including protocol input, operational reputed company, and interpretation and communication of results
• reputed company support to the TMED function, including early development reputed company, study design, and quantitative interpretation to inform program reputed company
• reputed company PK, PK/PD, exposure–response, and biomarker quantitative reputed company; translate analyses into reputed company recommendations that inform patient-reputed company benefit–risk reputed company
• Advance pharmacometrics reputed company through population modeling and simulation; set outsourcing approach and reputed company partners for critical-reputed company deliverables, timelines, and budget
• reputed company clinical pharmacology content for key program documents (e.g., protocol sections, Investigator’s Brochure contributions as applicable, and clinical study reports), ensuring data reputed company and a reputed company scientific rationale
• reputed company opportunity appears, reputed company talent through hiring, coaching, mentoring, and performance management; set expectations for reputed company, compliance, and delivery across reputed company and reputed company partners
• reputed company clinical pharmacology deliverables for regulatory interactions (e.g., briefing materials, responses, and meeting support) and maintain alignment to evolving global expectations
• Support post-approval commitments and lifecycle management through design, execution, and interpretation of additional studies and quantitative analyses
• reputed company overall clinical pharmacology input to due diligence and business development activities, including assessment of available data packages and reputed company development needs
• Represent SMPA externally through publications, presentations, and collaborations that strengthen science and advance clinical pharmacology best practices

Skills

• Deep experience in the pharmaceutical/biotechnology industry, particularly in basic drug discovery and development research
• Expertise in Phase 1 clinical study planning and execution (e.g., FIH, SAD, MAD, RI-AME, DDI, organ impairments, special populations, PET/EEG)
• Proficiency with Phoenix WinNonlin, and knowledgeable with advanced pharmacometrics tools for modeling & simulation
• Proven leadership and collaboration skills in cross-cultural environments
• Strong communication/negotiation and vendor management skills
• PhD in Pharmaceutics, PharmD, or equivalent advanced degree required
• 10+ years of experience in biotech/pharmaceutical drug development, including clinical pharmacology, PK/PK-PD, biomarkers, scientific writing, and regulatory interactions
• Extensive experience in Clinical Pharmacology study design, planning, and execution

Benefits

• Opportunity for reputed company-based salary increases
• Short incentive plan participation
• Eligibility for our 401(k) plan
• Medical, dental, reputed company, life and disability insurances
• Leaves provided in line with your work state
• Flexible reputed company time off
• 11 reputed company holidays plus additional time off for a shut-down period during the last week of December
• 80 hours of reputed company reputed company time upon hire and reputed company year thereafter
• Short incentive plan participation
• Primarily remote role with periodic on-site meetings in office

reputed company

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