Medical Director, Rare Disease/Gene Therapies

Company: Premier Research Group Limited
Location: Seattle
Posted on: January 14, 2021

Job Description:

Medical Director, Rare Disease/Gene Therapies Position at Premier Research Group Limited Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as Oncology, Analgesia, CNS, Rare Diseases, Dermatology and Pediatric Research. We're looking for a talented and innovative Medical Director with Rare Disease and Gene Therapy expertise to join our dynamic team! Working at Premier Research means being an individual - you will be recognised for your expertise and you will truly have an impact. You will be working in an aspiring and empowering environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it! As a Medical Director here at Premier, you'll play a major role in supporting Business Development activities aimed at winning new operational, providing input to consulting projects for Premier Research and providing medical monitoring, therapeutic oversight to study programs. You will have the opportunity to Premier Research clients with expert input into the design and implementation of clinical development programs of pharmaceutical products and medical devices in the fields of Rare Disease and Gene Therapy. You'll also be able to provide scientific, medical and strategic support to Premier Research team across all departments. What you'll be doing:

• Provide critical medical expertise to business development activities and perform scientific research for and provide specialized input into the RFPs
• Successfully develop and review medical monitoring and other study related plans; set up, document and communicate project specific medical monitoring requirements
• Attend Investigator Meetings and interact with Investigative site staff and client representatives; train project team and sites in the protocols
• Initiate medical monitoring activities during the start-up of clinical trials, including development of process documents aligned with the study protocol, budget, standard operating procedures, and ethical requirements
• Review site and project team queries, medical data including labs, patient profiles, CRF data and eligibility/enrollment reviews
• Support other medical monitors under medical guidance in the conduct of studies
• Ensure compliance with and adherence to all internationally recognized standards
• Properly process and address protocol non-compliances at Investigative sites and ensuring adherence to ethical guidelines
• Prepare for audits and inspections by sponsors or regulatory agencies You'll need this to be considered:
  • Graduate in medicine is a must (board certification or equivalent in pediatrics or clinical genetics strongly preferred)
  • Previous clinical experience in pediatrics or genetics is preferred along with at least 3 years of previous CRO/pharma experience in rare diseases or gene/cell therapies
  • Knowledge of ICH / GCP regulations as well as FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Excellent team player, collaborative and able to build an effective team
  • Ability to multi-task and work effectively in a fast-paced environment with changing priorities.
  • Excellent organizational and time-management skills, able to prioritize workload to meet deadlines
  • Is customer service focused in approach to work both internally and externally
  • Maintains a positive, results orientated work environment You have been redirected to a Premier Research job page

Keywords: Premier Research Group Limited, Seattle , Medical Director, Rare Disease/Gene Therapies, Executive , Seattle, Washington