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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