Director/Snr Director Oncology Clinical Development

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