Duties and responsibilities
Will lead teams in oncology and other therapeutic areas, ranging from top-ten pharma to biotech’s, with products at various stages of translational and clinical development.
Tasks will vary and may include:
- Leadership of multi-disciplinary clinical development teams consisting of tranScrip and client staff who provide all the activities that might be expected of an internal medical department during product development, licensing or launch:
- Provide strategic clinical development expertise in the preparation of clinical development plans and target product profiles,
- Design and implementation of clinical study protocols,
- Prepare and participate in regulatory interactions, for-example pre-IND meetings,
- Analyse and interpret clinical data in both ongoing and completed studies and acting as medical monitor or provide oversight, 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.
- Drug development experience with >10 years’ experience in pharmaceutical company (big pharma, clinical stage biotech and possibly CRO),
- Demonstrable good understanding of pharmaceutical medicine,
- Experience supporting translational medicine/clinical pharmacology in pharma/biotech, including products moving towards the clinic,
- Strong strategic thinker with solid experience in clinical development plan and execution, including protocol design, specifically first in human studies,
- Experience of dealing with major Health Authorities for Scientific Advice, Pre–IND, End of Phase 2, Pre-NDA meetings and Advisory Committees,
- The ability to analyse complex datasets, synthesise ideas and write cogent argument (and manage the teams involved) is essential,
- 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,
- 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 Dip Pharm Med or equivalent preferred,
- Post qualification degree in a scientific element of drug development preferred,
- Direct clinical experience of oncology therapeutics would be useful,
- Some other therapeutic area experience would be useful.
- Strategic focus with a hands on approach,
- Candidates must be demonstrably self-sufficient,
- Demonstrated strong team leadership skills in a matrix environment,
- 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 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,
- Evidence of successful lie management would be advantageous.
Location and commitment
The position will be home-based, preferably in the UK and Ireland.
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).
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.