Theragnostics was incorporated in the UK in 2015 with the aim of providing a portfolio of products to transform patient care in oncology through targeted molecular radiotherapy and molecular imaging diagnostic products. The word Theragnostics is derived from Therapy and Diagnostics and refers to the strategy of utilising radioactively labelled drugs.
Our culture is that of a true start-up, where our employees pride themselves on making a difference across the entire organisation and enhancing patient care through the development of our product(s). We value individuals who are motivated by helping us grow and ultimately serving the patients whom our products serve.
Based in our Bracknell, UK Office the Head of Research and Development (R&D) will be a critical role within Theragnostics responsible for defining, developing and delivering on the companies pipeline of products. Encompassing a project management element during the early growth stage of the company the role requires a solid understanding of chemistry manufacturing and control (CMC) requirements for drug development from discovery through to regulatory approval.
Key Roles and Responsibilities
• Leading CMC development & supply of new drug products for pre-clinical and clinical studies, and into commercial manufacturing
• Providing drug product development expertise to support products across the wide development stages from early development to life cycle management
• Managing and prioritising CMC resource across Theragnostics projects to meet company objectives
• Writing and reviewing suitable scientific reports & documentation to support regulatory documentation packages and establishment of manufacturing
• Leading projects with external contract development and manufacturing organisations and research organisations
• Acting as the technical strategic lead for identifying and evaluating new opportunities to expand Theragnostics therapeutic pipeline
Requirements for the role
• PhD in Chemistry (or equivalent knowledge or experience)
• Minimum 10 years’ experience within the pharmaceutical industry
• Experience in technology due diligence, evaluation and triage of opportunities
• Detailed understanding of regulatory requirements for development of pharmaceuticals with a particular focus on CMC for requirements for Phase 3 clinical studies and regulatory submissions to EMA and FDA
• CMC experience in F-18 and I-123 radiopharmaceutical development
• Strong English language communication skills
• Good leadership skills
• Experience with preparation of CMC sections of regulatory documentation for submissions and support in addressing questions from authorities
• Ability to apply knowledge across the team and contribute at project and portfolio level
• Able to engage with external experts on a scientific/technical level and translate into
• Ability to take the lead in technical assessment and recommendation of new product opportunities
• A solid track record of working with external partners
• Experience in building wide and effective networks of contacts inside and outside the organisation
What to do next…
If you are still reading and still interested, then we would love to hear from you! Please apply directly via LinkedIn or by sending your CV and cover letter to firstname.lastname@example.org!
In some circumstances we may be unable to contact every applicant with feedback. If you do not get a response from us within 2 weeks of the advert closing date, then please assume you have been unsuccessful on this occasion.