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Director, Clinical Pharmacology

Enigma Search
Enigma Search
8+ years
$230K/yr - $295K/yr
10 Dec. 24, 2024
Job Description
Job Type: Full Time Education: PhD/PharmD/MS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director, Clinical Pharmacology
Location: Not specified (likely field-based or company headquarters)
Company: A pioneering biotech company focused on advancing human healthspan

Job Overview:

The Director of Clinical Pharmacology will lead the translation of groundbreaking preclinical discoveries into clinical development, shaping therapies for aging-related conditions. This individual will be responsible for overseeing and representing the Clinical Pharmacology function in early clinical development, contributing to dose selection, safety, and pharmacokinetic studies.

Key Responsibilities:

  • Clinical Development Leadership:

    • Lead the Clinical Pharmacology function within cross-functional teams to design and execute early clinical development plans.
    • Develop and oversee Clinical Pharmacology strategies, including first-in-human protocols and studies evaluating safety, tolerability, pharmacokinetics (ADME), drug-drug interactions (DDI), thorough QT (TQT), renal and hepatic impairment.
  • Contribution to Experimental Medicine:

    • Contribute to experimental medicine studies focused on proof-of-mechanism in aging and age-related diseases.
    • Play a central role in dose selection strategies for Phase 2 studies.
  • Protocol and Report Development:

    • Author and review clinical protocols, study reports, investigational brochures, regulatory submissions (IND/CTAs), and statistical analysis plans.
  • Collaboration with Internal and External Teams:

    • Work closely with internal teams (Research, Biomarkers, Regulatory Affairs, etc.) and external partners (CROs, study vendors) to ensure project success.
    • Train CROs and study site personnel on protocols and address protocol-related queries.
    • Evaluate and oversee CROs and vendors to ensure study quality and adherence to standards.

Qualifications and Expertise:

  • Education:

    • An advanced degree (PhD, PharmD, or MS) in a field relevant to pharmaceutical development.
  • Experience:

    • 8+ years of experience in early clinical drug development, with proficiency in first-in-human, ADME, DDI, and TQT studies.
    • Hands-on experience in Phase 0 through Phase 2 trial methodology and clinical trial deliverables.
    • Strong knowledge of pharmacokinetics and clinical pharmacology, including managing CROs or development partners.
    • Expertise in Modeling and Simulation is preferred.
  • Regulatory Knowledge:

    • Familiarity with ICH GCP guidelines, FDA, and EMA regulations.
  • Skills:

    • Exceptional communication and leadership abilities.
    • Detail-oriented mindset with the ability to influence and collaborate within cross-functional teams.
    • A commitment to being onsite at least 4 days per week.

This position offers the opportunity to lead clinical pharmacology efforts in the development of cutting-edge therapies for aging and age-related diseases. The Director will play a key role in advancing the company's vision for improving human healthspan.