The company seeks an outstanding individual as VP of Clinical Research who will be responsible for the full scope of Clinical and Medical Affairs functions, including clinical trials, clinical research, data collection, safety and medical information programs. This individual will be responsible for working closely with Research & Development to ensure an effective linkage to Phase I, II and III clinical trial design, strategy, and ultimately to NDA filing. He/she will provide leadership to the whole organization in moving compounds effectively into, and through, the clinic. We are looking for a high-performing executive with a distinctive track record in the pharmaceutical or biopharmaceutical industry.
RESPONSIBILITIES:
The VP of Clinical Research is responsible for ensuring effective design of experimental protocols, developing/maintaining relationships with key thought leaders, reviewing promotional materials for scientific accuracy, serving as the clinical lead for advisory meetings, and advising all levels of executive management in development and implementation of clinical strategy.
The VP of Clinical Research will provide leadership in establishing the studies essential for determining the safety, efficacy, and marketability of drug candidates. He/she will also serve as the principal medical monitor responsible for overseeing contract research organization (CRO) activities, the implementation of clinical trials, and for the interpretation of the results from investigations, as well as working with a team to author scientific publications. The VP of Clinical Research serves as a key member of the executive team responsible for identifying/implementing the actions necessary to achieve corporate goals, and will also work closely with the R&D, Product Development, and Regulatory departments.
SPECIFIC DUTIES
• Designs clinical trial protocols and selects Clinical Investigators and Clinical Research Organizations
• Writes clinical sections of all regulatory documents, including the Investigational New Drug Application and Applications for marketing approval
• Evaluates safety data from clinical trials and reports safety findings to regulatory authorities and licensing partners
• Writes clinical study reports according to regulatory (FDA/ICH) guidelines
• Reports status of clinical programs to Project Teams and Management
• Supports Business Development licensing activities including the evaluation of the competitive landscape
• Identifies and maintains liaison with leading investigators in the areas of medicine where products are being developed
• Reports clinical study findings at professional meetings
• Manages clinical trial budget for both CROs and study sites
• Promotes continuing education and development of personnel system
• Assists project teams to identify clinical indications appropriate for the investigational drugs
• Assists research teams with the identification of new therapeutic areas of focus for potential drug candidates
REQUIREMENTS:
The strongest candidate will be a dynamic individual with experience in guiding the movement of late-stage drug candidates into the clinic and through successful implementation of clinical trials in a biopharmaceutical company setting. This individual should have a broad understanding of internal medicine and pharmacology. Successful candidates will have the self-confidence and skills to not only gain the respect of, but to lead and influence a highly educated and talented workforce. The best candidates will also have a passion for the mission of the company and the role that the clinical organization plays in driving the success of the business.
ADDITIONAL REQUIREMENTS:
• MD or MD/PhD degree with specialty/certification in internal medicine and subspecialty experience preferably in infectious disease, oncology, or inflammation, but other medical subspecialties (e.g., cardiology) will be considered.
• Minimum 5+ years experience in a pharmaceutical or biopharmaceutical company, preferably in a fast-paced, dynamic environment. Demonstrated experience in successfully leading clinical development of drug candidates from pre-clinical activities through clinical trials and successful product approval(s).
• Demonstrated expertise in managing complex collaborations and teams in support of executing clinical trials effectively, including effective management of projects and timelines and interpretation/evaluation of clinical data.
• Must be knowledgeable with FDA requirements, good clinical practices, and pharmaceutical clinical development a must.
• Demonstrated leadership experience, including excellent analytical, planning and communication skills in a dynamic environment. This individual must have a demonstrated track record of being results driven.
• Excellent oral, written, and interpersonal communication skills.
• Energetic with ability to prioritize and work on multiple projects at the same time.
• Must be open to some travel.
