Director Safety Physician
- Accountable for the quality performance of one or more safety management team(s) (SMTs)
- Oversees safety monitoring, signal management, and the benefit-risk of assigned products through the product life cycle
- Identifies and leads escalation, management, and communication of safety inquiries and concerns for assigned products
- Formulates and drives the optimal safety strategy for assigned oncology programs in clinical development at the portfolio level
- Presents and interacts with Regulatory Authorities on safety matters
- Oversees quality content of the safety contributions to clinical and regulatory documents such as briefing book for regulatory authority meetings, investigator’s brochure, clinical study report safety conclusion section, responses to regulatory authority inquiries, and other clinical/regulatory documents as needed
- Participates in due diligence for BioNTech’s Licensing /Acquisition initiatives
- Represents MSPv in Alliance management projects such as safety data exchange agreement negotiations; or joint oversight committees with development partners, and/or other collaborative development projects
- Serves as safety subject matter expert at the portfolio level and is the arbiter for safety-related issues in any of its constituting programs
- Ensures activities are performed in compliance with applicable law, global and local regulations, and in accordance with internal and external quality standards
- Trains and mentors Safety Physicians and Safety Scientists
- Medical Degree (or internationally recognized equivalent). A MD/PhD and/or certified training in a relevant medical discipline is a plus.
- Extensive drug safety/pharmacovigilance experience within the biopharmaceutical/biotechnology industry that includes the development of innovative drugs, BLA/MAA submissions, and advisory committee experience, preferably in immuno-oncology/inflammation therapeutic area(s)
- Exposure to, or direct experience in working with Regulatory Agencies on development strategies for innovative oncology products, particularly those of US
- Has achieved demonstrable results in a matrix organization and in a multidisciplinary team, experience in implementing GCP standards in clinical trials, in particular safety reporting in compliance with global and local regulations
- Your flexibility: flexible hours | vacation account
- Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
- Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
- Your health and lifestyle: Company bike
- Your mobility: Job ticket | Deutschlandticket
- Your life phases: Employer-funded pension | Childcare
Recommended Jobs
Mandarin speaking Job - IT Systems Engineer - ww
Please follow us on WeChat to see all our Cantonese and Mandarin jobs, interview tips and London news: Your New Job Title: Mandarin speaking IT Systems Engineer, London The Skills You'll Ne…
Audit Senior - Part Qualified Not For Profit
About the Firm: A well-established and forward-thinking accountancy practice in Egham is seeking a Part-Qualified Audit Senior to join their Not-for-Profit (NFP) and Charities team. This role off…
Machine Minder
Machine Minder with Mechanical Qualification Highly successful, continuously expanding chilled food company Location: Ealing area Salary: Up to around £37,000 per annum (paid hourly.) Benefits: Numer…
Broker - PVT
A leading global broker is looking for an experienced Political Violence & Terrorism Broker to join their specialty team. The role involves structuring and placing complex terrorism and political vio…
Year 6 Teacher — Southwark
An Outstanding Southwark primary is recruiting an experienced and inspiring Year 6 Teacher to join the senior phase on a Full-Time basis with a January 2026 start. The successful Year 6 Teacher will …
People & Culture Partner (12 month FTC)
ABOUT RIXO RIXO’s story began in the London living room of best friends Henrietta & Orlagh, born from their passion for vintage. Our philosophy is to evoke a wanderlust & free spirit in all o…
Building Surveyor
Building Surveyor – Housing Day rate: £350 per day (Inside IR35) Contract position: 3 months initially Hybrid – South London (4 days on site, 1 day home working) An exciting opportunity has aris…
Senior Franchise Manager
OVERVIEW: Are you our next Senior Franchise Manager Were looking for someone to join our Wholesale & Franchise team who will accelerate t he growth and success of franchise operations across k…
Year 4 Teacher - Exceptional Primary School in Hackney
Are you a passionate and creative Lower Key Stage 2 teacher ready for your next opportunity? Do you have the drive to inspire curiosity, independence, and a love of learning in your pupils? If so, th…
Luxury Wellness Concierge (0-hours)
Join a pioneering new wellness destination in Knightsbridge as a part-time, 0-hours Member Concierge where luxury and wellbeing are seamlessly intertwined. This is a unique opportunity to be part of …