Director Clinical Development -Immunology

139161
  • 280000 USD - 280000 USD
  • Westchester, United States
  • Permanent

Meet has partnered with a notable large pharma that is looking to enhance global well-being by making quality healthcare more affordable and accessible. Their mission unites individuals from diverse backgrounds across nearly 60 countries, all dedicated to improving lives worldwide.

 

The opportunity

 

They are seeking a dynamic Director to spearhead the development, execution, and management of diverse clinical programs worldwide, spanning all phases of clinical research. As the leader of study teams, you will navigate a matrix environment, providing direction to cross-functional teams. Your role encompasses independent management of daily clinical research projects, including the preparation and review of key documents such as protocols, Investigator’s Brochures, clinical study reports, and summaries for regulatory submissions.

 

Key Responsibilities:

  • Provide input to the clinical development plan and lead asset strategy, collaborating closely with functional areas like commercial, regulatory, pharmacovigilance, CMC, and pre-clinical development.
  • Play a pivotal role in the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings.
  • Foster relationships with opinion leaders in designated Immunology/GI areas.
  • Serve as a core member of the Global Project Team, maintaining expertise for the clinical development of the product.
  • Prepare and manage multiple Clinical Development Plans.
  • Lead or oversee cross-functional clinical development teams.
  • Support Global Clinical Operations in trial initiation, resource planning, study implementation, and successful completion.
  • Make presentations at Investigator Meetings and other relevant internal or external venues.
  • Secure necessary human resources for the Clinical Development plan.
  • Collaborate with the Clinical Supplies Group to ensure timely procurement and drug supply plans.
  • Resolve safety or clinical issues in consultation with Global Drug Safety and Pharmacovigilance.
  • Oversee the preparation of documents for IND/NDA and other regulatory submissions.

 

Your experience and qualifications

  • MD, DO, or equivalent combination of education and related work experience. Ph.D., PharmD, and DVM with a strong proven track record will be considered.
  • Minimum of 3 years of experience in a pharmaceutical industry environment or related area planning/managing clinical trials, with a proven ability to manage projects and/or lead project teams effectively.
  • Experience in the Immunology/GI therapeutic area is strongly preferred.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to manage multiple conflicting priorities and varied concurrent tasks, with 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, multitasking environment.
  •  

Travel: Approximately 30%, both domestic and international.

Sarah McGraw Division Manager

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