Barrington James

NY, US

Vice President Of Clinical Development

$68,000-$210,000 / YEAR

Vice President Of Clinical Development

San Diego | CA | USA

I am partnered with a clinical stage pharmaceutical company focused on advancing novel therapeutics for deadly infections. The client is looking for an experienced drug development professional to join their team as a Vice President of Clinical Development, driving the clinical strategy ensuring quality and safety at all times

Responsibilities:

  • Reports directly to CMO
  • Drive development of clinical strategy for products across pre clinical development, clinical research, manufacturing and regulatory affairs.
  • Ensure all clinical trials are executed on budget and within strict timelines
  • Oversee management of clinical trials to include; investigator selection, patient recruitment strategies, milestones, lab samples, data collection and analysis
  • Contribute to the Clinical Development Plan, Product Development Plans and Target Product Profiles
  • Develop protocols, investigator brochures and other relevant clinical documents
  • Vendor management – Identify suitable vendors, delegate vendor responsibilities, develop vendor reporting procedures and plan of action.
  • Review vendors performance on a monthly basis and ensure quality of work
  • Identify and qualify possible clinical trial sites
  • Build relationships to gain market advantage including thought leaders and principal investigators
  • Review SAE’s and safety data, ensure all relevant parties are notified and the company is compliant
  • Oversee regulatory filings, including authoring, reviewing and preparing correspondence and sections of INDs, BLAs, NDA’s, Annual Reports, Amendments, Supplements, Orphan Drug Applications and other regulatory submissions.
  • Contribute to the Clinical Development Plan, Product Development Plans and Target Product Profiles
  • Develop and maintain clinical SOPs ensuring GCP compliance
  • Ensure compliance to GCP, ICH and other ethical and company policy at all time
  • Be an internal expert providing due diligence on business development opportunities
  • Present the Medical and Clinical strategy to internal and external stakeholders, confidently relaying information to board of directors

This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply immediately as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to Oliver Lammas at [ Link Removed ] alongside a copy of your CV.

Job Requirements

Requirements:

  • Relevant MD
  • 5 + years’ experience in the pharmaceutical industry
  • Development experience in one of the following;  hemoncology, transplantation or monoclonal antibody development.
  • Peptide based therapies advantageous
  • Infectious disease experience