tranScrip is looking for experienced pharmaceutical physicians with strong general pharmaceutical skills, and track record across different therapy areas and stages of drug development.
This is an exciting opportunity to lead and provide medical input and oversight of clinical programmes, from early development to license applications and medical affairs across numerous indications in a variety of global projects.
tranScrip is a leading life science consultancy that provides specialist support to pharma and biotech companies in the development and lifecycle of medicines. We offer a flexible working environment and opportunities for considerable reward and continuing professional development.
Medical leadership of global development projects in oncology, infectious diseases, immunology and many other therapeutic areas, working as part of multi-functional teams for tranScrip’s clients ranging from top-ten pharma to small biotechs, with therapies at various stages of development from first in man studies to full clinical development, registration and peri-launch/post-launch phases.
Tasks will vary and may include leadership of or participation in multi-functional teams, including, tranScrip, client and other vendor’s staff, supporting various activities that might include:
- Medical input into design of clinical development programmes and regulatory strategies
- Design and oversight of clinical studies, also acting as medical monitor where applicable
- Analysing and interpreting clinical data in both ongoing and completed studies
- Medical support for interactions with national and international regulatory authorities, including preparation of briefing documents and attendance in scientific advice meetings
- Medical support for preparation of license applications (NDA, MAA)
- Medical input into due diligence activities for clients in-licensing new assets
- Managing investigator meetings, advisory boards and other scientific committees
- Medical support for communications and publications
Preferably drug development and life cycle management experience with >10 years’ experience in pharmaceutical company (CRO, big pharma or biotech) as a pharmaceutical physician. Solid drug development experience in specific therapy area(s) will be important, with background in oncology or advanced therapies/gene therapies being a particular advantage. Alternatively, ‘board certification’ in a specific therapeutic area (e.g. oncology, immunology, etc) with >5 years’ experience as a pharmaceutical physician.
The ideal candidates will be able to demonstrate:
- Track record in clinical development/registration of drugs in USA, Europe and/or Japan AND/OR hands-on experience of preparing and launching products, regionally or globally.
- Experience in interactions with major Health Authorities (FDA, EMA, PMDA and other national authorities) for Scientific Advice, Pre-IND, End of Phase 2, Pre-NDA meetings and Advisory Committees
- Demonstrable good understanding of pharmaceutical medicine, including all topics covered by the Dip Pharm Med coursework
- History of working in the service industry or as a consultant in the past and ability to work with clients would be a plus
- Qualified physician, GMC or equivalent registration preferred
- Dip Pharm Med or equivalent qualification preferred
- Post qualification degree in a scientific element of drug development (e.g. clinical pharmacology) or disease area would be a plus
- Candidates must be demonstrably self-sufficient and able to manage medical activities and external relationships without supervision.
- Ability to analyse complex data inputs, synthesise ideas and plans and write cogent arguments is essential.
- Willingness to operate in highly entrepreneurial environments, with the ability to be hands-on with projects, mentor and guide more junior members.
- Enthusiasm to attend global conferences, networking events and a variety of skills training and provide continuing professional development to colleagues.
tranScrip offers a competitive reward package, which includes:
- Permanent contract of employment
- Competitive base salary
- Bonus scheme
- Pension scheme
- Private health insurance and travel insurance
- Strong focus on CPD
- Career progression in a rapidly expanding organisation
- The position will be home-based, preferably in the UK and Europe, although US will be considered. Occasional travel to clients or tranScrip’s offices may be required.
- tranScrip fosters a flexible working environment and for the right candidate would be prepared to consider part time positions (e.g. 4 days per week).
You can apply directly online or by sending your CV with a short cover letter to email@example.com