An opportunity has arisen for an experienced drug development pharmaceutical physician with strong oncology and general pharmaceutical skills with a history of being part of successful teams and keen to take on the challenges of the new world of pharmaceutical medicine.
This is an exciting opportunity to lead and provide medical input and oversight within clinical development, license application projects 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.
- The position will be home-based, preferably in Europe but US will be considered.
- tranScrip is a Limited Liability Partnership and provides some level of flexibility of working depending on client projects and does not necessarily fit within conventional Full Time or Part Time definitions, however, most Senior Partners are expected to commit at least 4/5 FTE.
Will lead teams on oncology and other therapeutic area global projects, ranging from top-ten pharma to biotechs, with therapies at various stages of translational and clinical development and/or in peri-launch and post-launch phases.
Tasks will vary and may include:
Leadership or participation in teams from between 2 and more than 8 TranScrip, client and consultancy staff who providing 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 development of clinical trial 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,
- Medical support for sections in license applications,
- 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 established biotech) in oncology as a pharmaceutical physician OR possibly ‘Board certified’ in Oncology or related therapeutic area (such as Immunology) with >5 years’ experience as a pharmaceutical physician in an established pharmaceutical company,
- 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 oncology 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,
- Preferably keen to develop or have existing visible profile in the oncology space, such as well networked, membership of working parties, company board membership,
- 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,
- An asset would be of working in the service industry or as a consultant in the past and ability to work with clients,
- Considerable opportunity in both the Partnership and some clients could be provided to those with entrepreneurial business skills.
- Qualified physician, with Dip Pharm Med or equivalent preferred,
- Post qualification degree in a scientific element of drug development or disease understanding preferred (but not necessary),
- Some direct clinical experience of oncology therapeutics would be useful but not essential,
- 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. Candidates with big pharma experience only will need to show they can be self-sufficient and able to manage external relationships without supervision,
- 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. Being a general ‘team player’ isn’t enough, being able to forge and maintain team spirit is an absolute must-have,
- 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 looking for specific leadership and responsibility traits but in addition, as part of its own succession-planning, is also looking for aptitude to take on leadership roles within the Partnership. This is not obligatory, however,
- 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 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.
You can apply directly online or by sending your CV with a short cover letter to email@example.com