An opportunity has arisen for an experienced drug development pharmaceutical physician with strong clinical pharmacology and pharmaceutical medicine skills with a history of being part of successful teams and ready to develop the next stage of their career in the new world of pharmaceutical medicine.
This is an exciting opportunity to and provide medical input and oversight within clinical development, and license applications across numerous indications in a variety of global projects.
Working for a flexible and innovative organisation with opportunities to maintain or grow skills in the rapidly changing pharmaceutical medicine environment.
tranScrip is an almost unique organisation environment with opportunities for considerable reward and also a strong duty of care in terms of continuing professional development.
Will work with colleagues to provide translational medicine and clinical pharmacology input to teams working in the internal medicine, respiratory medicine, oncology, and possibly also other therapeutic area global projects, ranging from top-ten pharma to biotech's, with therapies at various stages of translational and clinical development and/or in peri-registration and peri-launch phases.
Tasks will vary and as you develop may include:
- Leadership or participation in multi-functional teams consisting of tranScrip and client staff who support all the activities that might be expected of an internal medical department during product development, licensing or launch and might include;
- Design and implementation of clinical study protocols within the assigned therapy area and establish / approve methods for design in the pipeline,
- Provide medical input and expertise in the preparation of clinical development plans,
- Analysing and interpreting clinical data in both ongoing and completed studies and acting as medical monitor where applicable,
- Assess requirements for due diligence and liaising with client senior management and the R&D teams,
- Planning and managing investigator meetings, advisory boards, and other scientific committees,
- Be involved with selecting and training clinical research investigators,
- Medical support for development of briefing documents for scientific advice with the FDA, EMA and national agencies,
- Medical support for sections in license applications,
- Medical support for communications and publications.
- Drug development and life cycle management experience with >5 years’ experience in pharmaceutical company (big pharma, clinical stage biotech and possibly CRO as a pharmaceutical physician and ideally have Membership of the Royal Colleges of Physicians (MRCP) and have passed the Diploma in Pharmaceutical Medicine (DPM),
- 3-5 years’ experience supporting translational medicine/clinical pharmacology in pharma/biotech or acting as a PI in a Phase 1 CRO,
- Experience of dealing 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,
- Enthusiasm to attend global conferences, networking events and a variety of skills training and provide continuing professional development to colleagues,
- Demonstrable good understanding of pharmaceutical medicine, including all topics covered by the DPM coursework,
- Working in the pharma service industry or as a consultant in the past and ability to work with clients, would offer an advantage,
- Commercial acumen and ability to develop business opportunities within their networks is an advantage.
- Qualified physician, with MRCP and DPM or equivalent preferred,
- Have completed 2 or 3 years of specialist training in a medical discipline,
- Some other therapeutic area experience would be useful.
- Candidates must be demonstrably self-sufficient; experience of working in CROs, as a freelancer or in biotech would indicate knowledge of working for and managing clients or industry partners,
- tranScrip works in teams with little or no hierarchical structures beyond a project leader, so collegiality and support of others as the norm, is required,
- tranScrip takes on major projects and programmes so being experienced in/prepared to take on big team responsibilities for such projects is highly desirable,
- tranScrip is an entrepreneurial environment, so the ability to be hands-on with projects, mentoring and guiding more junior members, is a must,
- Much of what tranScrip does results in documentation for regulators or internal client decision-making. Consequently, the ability to analyse complex data inputs, synthesise ideas and plans and write cogent argument (and manage the teams involved) is essential.
- 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. Occasional travel to clients or tranScrip’s offices may be required.
You can apply directly online or by sending your CV with a short cover letter to firstname.lastname@example.org