Director/Snr Director Oncology Clinical Development
- Employer
- Compugen USA, Inc.
- Location
- South San Francisco, CA
- Start date
- Jun 5, 2019
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- Discipline
- Clinical, Clinical Development, Clinical Research, Clinical Trials, Science/R&D, Research, Immunology, Laboratory, Oncology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
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A unique opportunity to work on first-in-class immuno-oncology molecules and lead a cross-functional team. The candidate will be a detail-oriented individual responsible for advancing the clinical trial pipeline drugs through phase 1/2 drug development. Knowledge of early development of antibodies in immuno-oncology, regulatory guidelines (including ICH, GCP), ability to multi-task, work independently, exercise sound judgment, and escalate issues are important for this role. This position reports to the Chief Medical Officer.
Responsibilities:
- Provide medical monitoring and pharmacovigilance (such as line listings of safety and efficacy data, review of SAE reports)
- Lead development of regulatory documents (such as protocols, IND submissions, eCRF), filing experience
- Lead pharmacovigilance activities, review narratives, clinical and laboratory data on an ongoing basis
- Proven excellent medical/scientific writing skills (authoring and / or reviewing abstracts, presentations and manuscripts)
- Lead the design of clinical trials
- Contribute to selection of drug candidates and relevant targets
- Oversee site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits
- Lead investigator and clinical advisory board meetings and consultant meetings
- Develop and manage relationships with collaborators and thought leaders
Job requirements
- M.D, Pharm D
- Board certification/eligibility and clinical experience in oncology or hematology/oncology
- MD with at least 5 years pharmaceutical or relevant scientific/medical/clinical experience; Pharm D with at least 10 years pharmaceutical industry experience in clinical trials
- Ability to work proactively and effectively applying creative problem-solving skills
- Excellent strategic planning, organizational and communication skills
- This role requires up to 30% travel in support of clinical study activities
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