Vice President, Clinical Development

Vice President Clinical Development

Located in New Jersey USA, the VP of Clinical Development will be responsible for all company clinical research activities globally; specifically for the design and execution of global clinical development and data collection programs to achieve successful timely drug development and approval.

Responsibilities include:

effective leadership and direction for global clinical drug development programs that support regulatory approval and subsequent commercialization, including strategy, design, operating plans and execution, working closely with VP Regulatory Affairs, the Medical Advisory Board and other appropriate internal and external committee



effective leadership and direction for Global Data Sciences and Reporting activities which address and control the end to end management of clinical data into and out of the organization



establishing and maintaining relationships with prominent clinical investigators, clinical research consortiums and patient advocacy groups for indications relevant to our clinical development programs



maintaining excellent relationships with pharmaceutical partners in clinical development programs, to meet near term expectations and with a view to future business development opportunities



participating in the development of additional business opportunities with other senior management with respect to clinical development strategic and operational input and capabilities



developing and implementing operationally effective clinical development plans with cost-containment considerations; effective budget planning and accountability



developing and supporting the clinical team leaders and other direct line reportees responsible for executing the company?s development projects



formulating, implementing and managing resource strategies with internal and external groups for clinical drug development projects; optimal internal and external resource utilization to design and execute clinical programs



developing, prioritizing and meeting measurable short and long term objectives for clinical research programs; delivering programs to predetermined budgets and timelines



ensuring trials are designed and conducted according to cGCP and all applicable regulations



maintaining awareness of advancements or changes in business, technology, regulatory, and processes influencing the conduct of clinical trials



Requirements:

MD with 10+ years in clinical phases of global drug development with several companies in senior management roles



broad knowledge of the drug development process, clinical development planning, clinical research methodologies and execution, regulatory requirements; some knowledge of biostatistics and epidemiology



knowledge of general pharmaceutical medicine and science in its application to clinical development programs



proven track record in delivering global clinical research programs to budget and timeline specifications



successful experience in coordinating internal and external resources for clinical development, and in working with pharmaceutical partners



direct hands-on experience in managing high-quality successful clinical trials and clinical trial project teams



credibility, influence and respect within the pharmaceutical industry



experience with orphan drugs and rare diseases preferred



demonstrated qualities of executive leadership: ability to interact productively and effectively influence other senior management and external colleagues; ability to set and communicate goals, and to drive efforts, overcome obstacles and achieve results within budget and timeline specifications; exceptional leadership, organizational, interpersonal and communication abilities; team-building and team-oriented approach; willing to contribute at all levels; highly developed negotiation skills; high ethical standards and integrity; independent thinking; excellent judgment in making information and logic-based decisions



Qualified applicants should forward CV to clinical@brunelmultec.ca