Current jobs related to Director, Global Regulatory CMC - Stevenage - Spur Therapeutics
-
Director, Global Regulatory CMC
3 days ago
Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full timeWhy 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...
-
Director of Regulatory Operational Excellence
3 weeks ago
Stevenage, United Kingdom GlaxoSmithKline Full timeSite Name: Poznan Grunwaldzka, GSK HQ, UK - Hertfordshire - StevenagePosted Date: Jan 7 2025We are seeking a dynamic Director of Regulatory Operational Excellence to lead and drive continuous improvement initiatives across key areas such as project management, data analytics/visualisation, third-party management, and resource allocation. In this strategic...
-
Associate Director, GRA Precision Medicine
3 weeks ago
Stevenage, United Kingdom ENGINEERINGUK Full timeYou will need to login before you can apply for a job.Site Name: UK - London - New Oxford Street, Belgium-Wavre, Poznan Grunwaldzka, Switzerland - Zug, UK - Hertfordshire - StevenagePosted Date: Jan 30 2025We are seeking an Associate Director, Global Regulatory Affairs (GRA) Precision Medicine & Digital Health to ensure the development and execution of...
-
Stevenage, United Kingdom GSK Full timeJob descriptionSite Name: Philadelphia Walnut Street, StevenagePosted Date: Feb 20 2025The Interventional Study Scientist Medical Director will lead the scientific design of interventional clinical studies, medical governance, and interpretation of results within the Medical Affairs organization (non-regulatory label-directed programs) for assigned...
-
Deferred Compensation Lead
18 hours ago
Stevenage, United Kingdom Guidant Global Full timeJob Title- Deferred Compensation LeadDuration- 12 monthsJob Type- RemoteOnsite ParkingHolidays are accrued for PAYE contractors and they get 28days to start off with which increases to 33days after 12weeks.About usOur client is a leading global advisory, broking and solutions company that helps clients around the world turn risk into a path for growth. With...
-
Stevenage, United Kingdom GlaxoSmithKline Full timeSite Name: UK - Hertfordshire - Stevenage, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: Nov 8 2024Are you energized by the opportunity to develop and deliver quality strategies for Research and Precision Medicine? If so, the Senior Director, Quality Business Partner: Research & Precision...
-
▷ [Immediate Start] IT Director
4 days ago
Stevenage, United Kingdom Jas Gujral Full timeIT Director We offer leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Our aim is to make the UK the most compelling and logical choice for UK and international partners to develop...
-
Stevenage, United Kingdom GSK Full timeAt GSK, we are creating an agile and more competitive Pharma business equipped to win in a dynamic external environment by improving our pipeline and performance. We will prioritize taking rapid, decisive action to focus the portfolio and accelerate timelines across four core areas to maintain or build global leadership (Respiratory, HIV/ Infectious Disease,...
-
Stevenage, United Kingdom myGwork - LGBTQ+ Business Community Full timeSite Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: Jan 31 2025*This role is 1 year FTC*With R&D and Digital and Tech's (D&T) joint goals to supercharge data in R&D, and the recent changes to the R&D organization to accelerate Research, this new role will be accountable for specified Digital and Tech products and...
-
Oncology Statistics Director
4 weeks ago
Stevenage, United Kingdom ENGINEERINGUK Full timeOncology Statistics Director - Disease Area StrategySite Name: UK - London - New Oxford Street, Mississauga, UK - Hertfordshire - Stevenage, Upper Providence, Waltham, WavrePosted Date: Jan 14 2025GSK Oncology has a commitment to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer. We need...
-
Stevenage, United Kingdom GSK Full timeJob descriptionSite Name: UK - Hertfordshire - StevenagePosted Date: Feb 17 2025We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings...
-
Stevenage, United Kingdom GlaxoSmithKline Full timeSite Name: UK - Hertfordshire - StevenagePosted Date: Feb 17 2025We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.Discover more about...
-
Stevenage, United Kingdom GlaxoSmithKline Full timeSite Name: UK - Hertfordshire - StevenagePosted Date: Feb 19 2025We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.Discover more about...
-
Stevenage, United Kingdom VONQ-1 Full timeSalary: EUR Monthly Hours:36.00 - 40.00 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. Discover more about our company wide...
-
Stevenage, United Kingdom GSK Full timeJob descriptionSite Name: UK - Hertfordshire - StevenagePosted Date: Feb 19 2025We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings...
-
Stevenage, United Kingdom ENGINEERINGUK Full timeYou will need to login before you can apply for a job.Site Name: USA - Massachusetts - Waltham, Switzerland - Zug, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: Jan 28 2025At GSK, we are creating an agile and more competitive Pharma business equipped to win in a dynamic external environment by improving our pipeline and...
-
Director, External Innovation Precision Medicine
3 weeks ago
Stevenage, United Kingdom ENGINEERINGUK Full timeDirector, External Innovation Precision MedicineSite Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, USA - Massachusetts - WalthamPosted Date: Jan 29 2025The Director External Innovation, Precision Medicine will be responsible for leading the development of new partnerships with external companies to progress precision medicine,...
-
NIS P&D Study Delivery Lead, Associate Director
3 weeks ago
Stevenage, United Kingdom ENGINEERINGUK Full timeYou will need to login before you can apply for a job.NIS P&D Study Delivery Lead, Associate DirectorSite Name: UK - Hertfordshire - Stevenage, Belgium-Wavre, Canada - Ontario - Mississauga, GSK HQ, USA - Pennsylvania - Upper ProvidencePosted Date: Jan 24 2025We create a place where people can grow, be their best, be safe, and feel welcome, valued and...
-
Stevenage, United Kingdom GlaxoSmithKline Full timeSite Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: Feb 3 2025With R&D and Digital and Tech's (D&T) joint goals to supercharge data in R&D, and the recent changes to the R&D organization to accelerate Research, this new role will be accountable for specified Digital and Tech products and services for R&D Global...
-
Director Business Operations NIS Planning
6 days ago
Stevenage, United Kingdom GlaxoSmithKline Full timeSite Name: UK - Hertfordshire - Stevenage, Mississauga, Warsaw, WavrePosted Date: Feb 18 2025Job Purpose GSK's success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired,...
Director, Global Regulatory CMC
1 month ago
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
