Director, Regulatory Science - Innovative Gene Therapies

Location
Boston, Massachusetts
Posted
Aug 23, 2018
Required Education
Bachelors Degree
Position Type
Full time

Director, Regulatory Science - Innovative Gene Therapies

Boston, Massachusetts, United States · Regulatory Affairs

DESCRIPTION

Location: Boston, MA
Reporting to: Vice President, Regulatory Science

Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. Orchard is a fast-growing and well-funded company with ground-breaking science and a broad pipeline that includes several products in late stage development and at least one BLA planned for the coming year. With locations in London and California, and a new US headquarters in Boston’s Seaport District, Orchard is building its Boston regulatory team with several newly-created roles for dynamic regulatory professionals who aspire to excellence and have the skills and mindset to work in the leading edge of gene therapy science.

Responsibilities

The Director of Regulatory Science will lead the US regulatory strategy for at least one late stage asset heading into BLA preparation and other pipeline projects associated with the full range of regulatory vehicles such as orphan, breakthrough therapy, rare pediatric disease, and RMAT designations, and collaborative interactions with CBER. This role offers a rare opportunity for both professional advancement and to have a real and timely impact on the development and approval of therapies with the potential to transform patients’ lives.

  • Define and implement regulatory strategy for assigned programs to expedite clinical development and approval of important therapies for unmet medical needs
  • Provide regulatory leadership and guidance, including identifying and assessing regulatory risks, to cross-functional development teams in line with US, European, ICH, and other applicable requirements to ensure compliance, and achieve timelines and deliverables
  • Plan, prepare, and review submissions to regulatory authorities to support the conduct of clinical trials and product approval (IND, CTA, BLA, MAA)
  • Prepare meeting requests and briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be the primary liaison with regulatory authorities for day-to-day interactions
  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
  • Train and mentor other regulatory affairs personnel

REQUIREMENTS

  • B.S. or higher level degree in a scientific discipline preferred
  • At least 10 years of experience in Regulatory Affairs strategy, ideally in biologics
  • Experience with cell or gene therapies highly desirable, but not essential
  • Previous experience as a Regulatory Lead, with responsibility for regulatory strategy and oversight of regulatory activities and serving as contact with FDA
  • Previous experience leading health authority interactions (e.g. pre-NDA/BLA, EOP2 meetings, etc.)
  • In depth knowledge and understanding of FDA regulations and guidelines, with ability to interpret impact on development programs; international experience is a plus
  • Self-motivated and independent, with ability to thrive in a global cross-functional team environment with experience managing people and project teams; be a role model to others
  • Excellent organizational skills and strong attention to detail, and ability to prioritize effectively and handle multiple tasks
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment and to interact effectively with Regulatory Authorities

BENEFITS

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including an annual bonus and a stock option plan. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; and access to a voluntary 401(k) with company match. Orchard Therapeutics is an equal opportunity employer.