Ring Therapeutics Inc. is a privately held, early-stage biotechnology company pioneering a completely novel form of gene therapy by exploiting a family of naturally occurring commensal viruses to create the first redosable and targetable DNA medicines. This approach enables a powerful new class of tropic, persistent, non-integrating vectors that overcome the immunogenicity, and limited tropism of existing gene therapy vectors. Ring Therapeutics is leveraging this versatile technology to develop a broad pipeline of novel, targeted medicines for disease with high unmet medical need.
Ring Therapeutics was founded by Flagship Pioneering, focused on launching breakthrough companies based on internally conceived innovations and insights. Flagship Pioneering has created over 40 groundbreaking companies over the past fifteen years, all of which are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability. These companies include Seres Therapeutics (NASDAQ:MCRB), Moderna, Syros Pharmaceuticals (SYRS), Rubius Therapeutics, Axcella Health, Evelo Biosciences, and Indigo Agriculture.
Ring is seeking a talented and highly motivated Director of CMC Project Management to play a vital role in the company’s efforts to progress the development of our lead candidates to IND. The candidate will be responsible for providing strong leadership and expertise to drive teams (internal and external) to execute on CMC deliverables and initiatives required to meet the goals of the organization. The successful candidate will work closely with scientists across Ring, as well as the Flagship Pioneering team to rapidly advance CMC activities to enable research programs to get to IND. S/he will be comfortable working in and contributing to a highly dynamic and cross-functional team environment. The ideal candidate must be independent, open-minded, goal-oriented, have excellent communication skills and work in a fast-paced entrepreneurial environment.
- Provide high quality program management to cross functional CMC teams supporting the development of our platform from research to clinical programs.
- Possess a comprehensive understanding of CMC development to guide program teams to define the key scientific questions, program strategy and objectives, translating these into optimal deliverables, cross-functional plans, timelines, and budgets.
- Partner with the head of Technical Operations and Technical Operations teams ensuring a robust CMC strategic and operational plan and timelines.
- Coordinate CMC teams, including scheduling and facilitating meetings, sending out agendas, managing team documentation, and tracking goals and action items
- Identify and mitigate CMC risks with input from team members.
- Ensure all decisions made on the development programs are assessed as to their impact to CMC.
- Work closely with Finance and the cross-functional program teams to establish CMC related budgets and resourcing plans. Is accountable to monitor plans and ensure CMC projects have the required resources and budget.
- Will interface with and drive collaboration between CMC and the various teams at Ring.
- Work in collaboration with the head of Ring Program Management to build the Ring PMO including defining, establishing, and maintaining the program management tools and systems to enable efficient and effective management, tracking and reporting of the research programs as it pertains to CMC.
- Ensure efficient and effective communications of CMC related information to all levels of the organization.
- Manage external collaborations associated with CMC development and manufacturing activities.
- PhD (6-8 years relevant experience) or BS/MS (10-12 years relevant experience) in bioengineering, chemical engineering, biology, virology, biochemistry or related field.
- Experience in the development of viral vectors, biologics, or cell therapeutics from bench to product approval
- Demonstrated ability in working with highly skilled teams in a fast-paced, entrepreneurial, and technical environment.
- Strong interpersonal and communication skills with proven track record of facilitating and managing cross-functional teams to deliver complex, multi-year CMC projects.
- Expertise in at least one CMC technical area such as upstream, downstream, fill/finish, or analytical development.
- In depth knowledge of cGMPs for biologics manufacturing.
- Competent with MS Project Professional or other project management tools to manage project scheduling and tracking.
- Proficiency with Microsoft Office.
- Gene therapy or viral vector experience.
- CMC project management background and understanding of clinical Gene Therapy drug development.
- Record of successful regulatory filings (INDs, BLAs, MAAs).
- Prior CMO project management experience.
- PMP certification.
Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.