Los Angeles, CA
24 days ago
- 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.
- 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.
- 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.