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Job

Head of Clinical Sciences

  • Location

    Los Angeles, CA

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Karina Nurmberg

  • Contact email:

    k.nurmberg@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    24 days ago

  • Expiry date:

    2022-07-29

Job Summary

  • Responsible for all aspects of clinical trial design, planning, and execution.
  • Create Clinical Development Plans for review/input from head of development.
  • Support regulatory filings.
  • Support Business Development activities from clinical development perspective.

Job Details

  • Develop innovative, efficient, effective clinical development plans and trial designs.
  • Leads and manages study team of external experts in medical, safety, clinical operations, statistics, biomarkers, clinical pharmacology, regulatory, and quality assurance in order to execute clinical studies.
  • Author clinical protocols, related manuals/documents, trial registry, and study reports with support from external subject matter experts (SMEs).
  • Oversee trial and program budget planning and control with aide of Clinical Trial Manager.
  • Review informed consents, lab manuals, CRF designs, clinical query design, deviations, etc.
  • Review materials to support SIVs, Investigator Meetings, and Safety Review Committees.
  • Review clinical database on routine basis with aide of Data Management and statistics at CRO.
  • Review patient eligibility and address questions from CROs, external SMEs, and site staff.
  • Identify clinical trends in datasets and escalate to Head of Development as appropriate.
  • Review SAE narratives from Safety Group at CRO.
  • Review and validation of clinical study reports and clinical portions of other regulatory documents (IB, DSUR, responses to health authorities, etc).
  • With support of regulatory vendor, drive regulatory filings INDs/CTA, NDAs/BLAs/MAAs, Orphan Status, Fast Track, Breakthrough Designation, etc.
  • Ensure high quality deliverables and support quality assurance (SOPs, training, CAPAs).
  • Partner with Chemistry, Biology, and others in Research to guide and support pipeline projects from clinical perspective.
  • Stay current and forward looking by attending relevant conferences and gathering competitive intelligence through publications, press releases, etc.
  • Author abstracts, posters, and presentations for scientific and clinical conferences.

Candidate Qualifications

  • Degree in Life Sciences (MD, PhD, PharmD, MS, RN or other).
  • 5-10 years’ experience in clinical science, clinical research, clinical development or equivalent in oncology.
  • Proficient knowledge of oncology, GCP/ICH, drug development, study design, statistics, biomarkers, pharmacokinetics, clinical operations in order to lead clinical trials.
  • Experience managing outsourced clinical studies (insourced or outsourced).
  • Demonstrated success as a clinical trialist working closely with/leading team of colleagues in medical, safety, statistics, biomarkers, clinical pharmacology, regulatory, and quality assurance.
  • Ability to work independently, be self-motivated, set priorities, handle multiple tasks and projects with a high degree of efficiency and comfort with ambiguity.
  • Operate with a high degree of autonomy and professionalism in a fast-moving start-up environment.

Preferred Additional Qualifications

  • 10+ years of experience in pharmaceutical R&D, target discovery or similar in a biotech, pharmaceutical or similar company.
  • Experience leading IND/CTA and NDA/BLA/MAA filings.

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