tranScrip, a leading specialist service provider in drug development, is poised for accelerated growth and wishes to appoint a ATMP-Experienced Pharmaceutical Physician to support key business development activities.
This is an exciting opportunity to lead and provide medical input and oversight within clinical development, license application and medical affairs 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 lead teams on ATMP 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 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 >10 years’ experience in pharmaceutical company (CRO, big pharma or established biotech)
- Experience of leadership and management of teams in clinical development/registration of drugs in USA, Europe and/or Japan AND/OR hands-on experience of preparing and launching ATMP products, regionally or globally,
- 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,
- Good network within the ATMP space, membership of working parties, etc would be a plus,
- 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 Dip Pharm Med coursework,
- Working in the pharma service industry or as a consultant in the past and ability to work with clients, would offer an advantage.
- Qualified physician, with Dip Pharm Med or equivalent preferred.
- 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,
- Opportunities for enhanced earnings via our unique variable remuneration structure.
- 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