Teva Director Clinical Development - Oncology 

United States, New Jersey 

625364777

• The Director will foster relationships with opinion leaders in assigned Oncology areas.
• Will be a core member of the Global Project Team
• Will have and maintain the expertise necessary for the clinical development of the product
• Prepares and manages multiple Clinical Development Plans
• Leads or oversees the cross-functional clinical development team
• Supports Global Clinical Operations in clinical trial initiation, resource planning, study implementation and successful completion
• Makes presentations at the Investigator Meetings and other relevant internal or external venues
• Responsible for securing the required human resources to implement the Clinical Development plan
• Works with Clinical Supplies Group to ensure clinical drug supply plans and timely procurement with the clinical supplies group
• Ensures clinical trials comply with clinical guidance, ICH, GCP, in agreement with the laws of the relevant countries and Teva Standard Operating Procedures
• Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigliance, VP Clinical Research and the Head of the Global Respiratory Therapeutic Area as needed.
• Oversees the preparation of documents for IND/NDA and other regulatory documents
• May lead an NDA submission team independently, as needed
• Partners cross-functionally with departments such as Regulatory Affairs, Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, GCO, and GCPR in the execution of Clinical Development Plans
• Capable of analyzing and interpreting clinical results and provide a guidance to prepare high quality reports working with Medical Writing
• Responsible for authoring protocol synopses and working with Medical Affairs and provides input and direction to the review and finalization of Protocols, Clinical Study Reports and other relevant clinical documents
• Author and/or review abstracts, posters and manuscripts, present data at scientific meetings, as needed
• Represent Teva at Scientific meetings, advisory boards, KOL boards and meetings with regulatory agencies, as needed

The expectation is for the person hired into this role work in a hybrid environment out of the West Chester, PA office or Parsippany, NJ office

• MD, DO or equivalent combination of education and related work experience. PhD, PharmD, DVM with strong proven track record will be considered
• Minimum of 3 years experience in a pharmaceutical industry environment or related area planning/managing clinical trials, with proven ability to manage projects and/or lead project teams effectively. MD/DO without prior industry experience but with relevant knowledge and expertise, in clinical trials will be considered
• Experience in the Oncology therapeutic area is strongly preferred
• Excellent interpersonal, verbal and written communication skills. Ability to manage multiple conflicting priorities and varied concurrent tasks, 2-4 years of managerial experience preferred
• Strong sense of urgency and understanding of time pressures, ability to thrive and enjoy working independently in a fast-paced, multi tasking environment

Travel:

• Approximately 30%, both domestic and International

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