Director Clinical Development - Hematology-Oncology
Affinity Search - San Diego, CA

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Director Clinical Development Hematology-Oncology
(Title Commensurate with Experience)

Under the supervision of the Vice President of Clinical Development and Medical Affairs, the Clinical Development team member drives and executives the goals for the study design, plan, protocol
development, implementation and monitoring of the company’s Phase I/II Oncology/Hematology clinical trials. The position will provide key overall clinical, scientific and/or logistical support to
clinical development programs and is responsible for the compliance of the department and the company to regulatory standards and procedures.

Summary:
  • Assist in or design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents
  • Provide clinical input for clinical protocol monitoring guidelines and analysis plans
  • Drive clinical interpretation of study data. Track emerging efficacy and safety profile of drugs
  • in on-going clinical trials; inform Clinical Development team of changes in the efficacy/safety
  • and/or risk benefit profiles as they occur
  • Provide input and/or prepare clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis
  • Plans, Data Management edit check specs, clinical supplies package diagrams and labeling)
  • Lead or assist in the development of publications – abstracts, manuscripts, slides, etc.
  • In collaboration with team members (e.g., Clinical Operations, Data Management), assist in identifying / evaluating / monitoring vendors, monitoring clinical trial conduct/status
  • Assist in database finalization, reviews of study results, results interpretation and CSR’s
  • Assist in planning and presentation conduct of investigator meetings and Advisory Boards
  • Assist with field site questions during conduct of trials as needed
  • Coaching and mentoring less experienced Clinicians as assigned

Requirements:
  • Medical Doctor (MD) or graduate level degree preferred
  • Minimum Bachelor’s level degree or equivalent experience required in a scientific or clinical
  • discipline (Clinical Pharmacology, Nursing)
  • Hematology and/or Oncology experience required
  • 4-8 year’s clinical development experience in the pharmaceutical or biotechnology industry (depending on title or degree)
  • Phase I–III clinical trial experience preferred
  • Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts
  • Working knowledge of the IND/NDA process
  • In depth knowledge of GCP/ICH guidelines
  • Strong written and verbal communication skills (fluency in written and verbal English) as wel as proven ability to interact with different functional groups
  • Leadership skills including a collaborative and team-oriented approach
  • Good organizational, time management and interpersonal skills, proficiency in computer and software skills
  • Available for some travel, including overnight stays
  • Experience with regulatory submissions is an asset

ADA Notations:
  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
  • Regular communication (hearing/speaking)
  • Routine office duties including computer keyboard use and some lifting of light-weight office
  • equipment and files as needed
  • Vision requirements include: close vision and ability to focus
  • Noise conditions range from quiet to moderate

The Graymore Group - 6 months ago - save job - block
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