Clinical Development Director

1 week ago

Parsippany, New Jersey, United States Teva Pharmaceuticals Full time
About the Role

The Director, Clinical Development will be responsible for leading the development, execution, and management of several clinical programs worldwide across all phases of clinical research. This role will oversee study teams and lead cross-functional teams in a matrix environment.

Key Responsibilities
  • Develop and execute clinical development plans, ensuring timely and successful completion of clinical trials.
  • Lead cross-functional teams, including clinical operations, regulatory, and pharmacovigilance, to ensure seamless execution of clinical trials.
  • Provide input to the clinical development plan and lead the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings.
  • Foster relationships with opinion leaders in assigned Respiratory/pulmonary/atopic disease areas.
  • Prepare and manage multiple Clinical Development Plans, ensuring alignment with company goals and objectives.
  • Lead or oversee the cross-functional clinical development team, ensuring effective communication and collaboration.
  • Support 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 Pharmacovigilance, SVP Late Clinical Development, and the Disease Area Heads, 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, Global Clinical Operations, and CROs in the execution of Clinical Development Plans (CDPs).
  • Capable of analyzing and interpreting clinical results and provide guidance to prepare high-quality reports working with Medical Writing.
  • Working with Medical Writing team, responsible for authoring protocol synopses, providing 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.
Requirements
  • MD, DO, or equivalent combination of education and related work experience. PhD, PharmD, DVM with strong proven track record will be considered.
  • Minimum of 2 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.
  • Experience in the Respiratory/pulmonary/allergy therapeutic area is strongly preferred.
  • Excellent interpersonal, verbal, and written communication skills. Ability to manage multiple conflicting priorities and varied concurrent tasks 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, as needed.

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