Vice President, Head of Global Clinical Development

Alternative Resources Company

Vice President, Head of Global Clinical Development

Vice President, Head of Global Clinical Development
 
The primary role of this position will be to provide leadership and direction for the company’s pipeline of clinical development programs in Dermatology, Immunology, Oncology and Metabolic. The Head of Global Clinical Development will be responsible for the strategy, direction and design and execution of the company’s clinical development plans. Responsibilities also include collaboration with strategic business partners. Individual will also have direct line responsibility for Clinical Operations, Biostatistics and Data Management globally.
 
Responsibilities
  • Responsible for the overall clinical development program of both small molecule and biologics drug candidates in Company pipeline
  • Conceive, design and manage clinical aspects of regulatory strategies and interactions with Health Authorities
  • Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
  • Internal evaluation of outside collaboration opportunities and provide clinical guidance to the identification of clinical candidates
  • Participate in senior management business and clinical strategy development and implementation.
  • Build and leverage cross functional collaborative relationships to achieve shared company goals.
  • Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders
  • Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners
 
Knowledge, Skills and Abilities
Leadership and management experience in the formulation, design, implementation and execution of global clinical drug development strategies, including the design and conduct of clinical trials through CRO (contract research organizations), the requisite data management and statistical requirements, presentations and negotiations with regulatory authorities in the U.S, Europe and other health authorities globally.
 
  • Experience in managing clinical programs in diverse therapy areas is preferred
  • Experience or knowledge of Dermatology, Immunology or Oncology disease drug development preferred
  • Experience in translational medicine, clinical pharmacology and early stage development is desirable.
  • Excellent knowledge of the competitive environment for drugs in the Dermatology marketplace and in research and development pipelines
  • Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
  • The successful candidate will, possess excellent communication skills and will be capable of articulating the Company’s clinical and regulatory strategies and progress to a wide audience including the Board of Directors, Company employees, and the investor community.
  • Must be science- and data-driven
  • Ability to work collaboratively internally and externally.
  • Extensive and productive first-hand experience in presentations, discussions and communications with the FDA and the EMEA.
  • Excellent professional relationships with international Dermatology thought leaders and experts, and support groups for commercial development of Dermatology products.
 
Qualifications
  • MD required, Board Certification in Dermatology preferred however open to Dermatology or Immunology, can also consider Metabolic Disorders or Oncology
  • 15 years minimum experience with 3 to 5 years of clinical practice treating patients and 10 – 12 years in pharmaceutical and/or biotechnology industry experience in clinical development of innovative programs
  • Multiple years of management experience leading clinical science and clinical operations in diverse therapy areas
  • A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s)