Executive Director, Clinical Development - Oncology

Company: Institute for Credentialing Excellence
Location: Palo Alto
Posted on: May 24, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company

• Lead Hematology Oncology Clinical Development Product Team and Lead cross-functional strategy for development of Oncology products
• Develop and implement strategic clinical plans in alignment with goals for the Hematology Oncology Therapeutic area.
• Set clinical development plan for lead asset
• Contribute to clinical development strategy for solid tumors
• Work within a matrix Research and Development organization
• Devise executive strategy to develop and implement clinical studies for investigational medicines and new indications for approved medicines
• Work closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, preclinical, external partners, pharmacovigilance/drug safety) to facilitate the execution of clinical trials and programs
• Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjunction with project team members, regulatory affairs and senior management
• Provide clinical/scientific input during the development, execution and completion of clinical trials
• Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, etc) and review sections from other functional areas
• Review and prioritize Investigator Sponsored Trials
• Serve as lead medical representative with regulatory agencies
• Identify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
• Work with medical affairs on KOL mapping, publication planning
• Work with DM on planning for data extractions in support of clinical data
• Lead the development and implementation of communication/education programs designed to effectively communicate the therapeutic area to key opinion leaders, investigators and physicians
• Lead clinical advisory board meetings to obtain strategic input into clinical program development
• Serve as clinical (and medical) resource for clinical issues raised by internal and external collaborators, investigators, consultants and business development and investor contacts
• Partner with corporate development on the identification of external assets to build and strengthen the therapeutic area
• Provide clinical expertise and strategic input on new product concepts, long-range strategic plans and licensing opportunities
• Provide leadership to the multidisciplinary team andmay manage other members of the clinical development team
  • 10 plus years of pharmaceutical development experience in hematology-oncology therapeutic areas
  • Demonstrated scientific and therapeutic experience in oncology
  • Experience in preparation of regulatory submissions (INDs and NDAs) to US and European regulatory agencies. Lead preparation of clinical portions of relevant regulatory documents.
  • Excellent written and verbal communication skills and proven ability to work in an international collaborative environment
  • Ability to effectively lead cross functional teams and successfully leverage internal and external partnerships
  • Excellent organizational and time management skills, ability to lead and manage multiple complex projects
  • Demonstration of Jazz values in previous employment
  • Demonstrated leadership ability
  • A scientific track record demonstrated by publication record in peer reviewed journals
  • Travel required (up to 10%-20% of the time)
  • Medical degree, MDwith specialized training in Hematology, Oncology and/or Transplant; U.S. Board Certification/Eligibility preferred

Keywords: Institute for Credentialing Excellence, Palo Alto , Executive Director, Clinical Development - Oncology, Executive , Palo Alto, California