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Sr. Director, Global Regulatory CMC

2 months ago

boston, United States Spur Therapeutics Full time

Why Spur?

Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists, physicians and other professionals who are singularly focused on using cutting-edge science and technology to transform the treatment of serious and debilitating chronic diseases.


What We Are Trying to Accomplish

We are a clinical-stage biotech company developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. Founded in 2015, Spur is focused on developing innovative, one-time treatments that set new standards of care. Our integrated gene therapy platform includes in-house capabilities in research, protein engineering and clinical development, and we optimize every component of our product candidates to develop first- and best-in-class gene therapies. We are currently advancing a highly differentiated gene therapy candidate in a Phase 1/2 clinical trial in people with Gaucher disease. We are working on additional programs in research, with a focus on CNS and cardiovascular diseases, to reach even more patients with our potentially life-changing treatments. Spur is global, with research facilities and offices in Stevenage, UK, and offices in Boston and New York.


How We Will Do It

We are relentless in our pursuit of transformative medicines for patients. We take innovation seriously and know we need to be bold both in our science and in every aspect of our work. We also know we can only achieve these things together, so we act as one Spur and expect that of each colleague in the company. We always do the right thing – the trust of patients and their caregivers is critical to our success. If you have an entrepreneurial mindset, are willing to work hard to transform the lives of patients, and share our values, then Spur could be the place for you.


Role Purpose

This is a hybrid role based at the Stevenage, UK or Boston, MA office location. The Sr. Director Regulatory CMC is responsible for overseeing the development and implementation of global regulatory CMC strategies for assigned Spur global gene therapy programs, including those both in the clinic and in development. The position will provide strategic and operational leadership for regulatory CMC activities, interfacing with CMC, Clinical, and Clin Reg teams. Functions include CMC regulatory strategy, submission generation in tandem with CMC, submission reviews, and health authority interactions. Spur is rapidly embarking on a phase 3 program with aggressive timelines for enrollment and application. We are also actively establishing a new CDMO for the phase 3 asset. This position will be heavily involved in ensuring timely and coordinated preparedness for both.


Role and Responsibilities

  • Develops CMC regulatory strategy for Spur development-phase projects, including identifying potential regulatory challenges and strategies for managing regulatory risk
  • Works with CMC to define topics for scientific advice interactions and leads meeting preparation including providing strategic regulatory input into the structure and content of briefing documents
  • Provides strategic regulatory input into the structure and content of core CMC regulatory documents and provides regulatory review of content
  • Ensures appropriate cross functional input to CMC regulatory questions and works with cross functional colleagues to respond to regulatory questions in a timely manner
  • Contributes overall project strategy via membership of the project teams
  • Provides CMC regulatory representation to relevant sub-teams such as CMC teams and regulatory teams
  • Collaborates with cross-functional colleagues to ensure consistency of approach to CMC regulatory challenges across the portfolio/platform
  • Leads CMC regulatory meetings, ensuring appropriate input from SMEs and ensuring advice and commitments are clear
  • Maintains an awareness of CMC development activities to ensure regulatory aspects are appropriately considered
  • Maintains an awareness of CMC regulatory guidance and intelligence and ensures this is considered in project CMC strategy


Qualifications and Experience Required

  • Strong scientific background, preferably in Biological Sciences or Pharmacy/Chemistry
  • At least 10 years’ experience of working in CMC regulatory disciplines in a pharmaceutical/ biotech company
  • Knowledge and experience of the requirements for CMC development of biologics for registration including an appreciation of the development of manufacturing processes and analytical strategies
  • Experience of developing process control strategies in line with regulatory expectations
  • Detailed knowledge of CMC regulatory requirements throughout development and registration
  • Demonstrable experience of providing strategic regulatory input to CMC strategy
  • Experience of participating in and leading preparation for, regulatory meetings
  • Significant experience of late stage development


Skills Required

  • Excellent communication and interpersonal skills and ability to work collaboratively in matrix teams
  • Excellent written communication and presentation skills
  • Proficient user of common business computer packages, collaborative tools and RIMS
  • Ability to manage multiple activities, respond to changing business demands and deliver to short timelines
  • Ability to work autonomously and within a multi-disciplinary and multi-national team environment
  • Ability to make strategic decisions with respect to CMC regulatory content and strategy
  • Effective time management
  • Ability to travel to meetings in Europe, US or further afield as the role requires