Translational Medicine/Clinical Pharmacology Pharmaceutical Physician
4 weeks ago
Duties and responsibilities
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.
Experience
- 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) examination.
- 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, and responses to questions from regulators during the MAA/NDA review process.
- 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.
Qualifications
- 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.
Personal attributes
- 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 arguments (and manage the teams involved) is essential.
- Excellent interpersonal skills.
- High level of attention to detail.
- Good level of proficiency in Microsoft Word, Excel and PowerPoint.
- Outstanding written and oral communication skills.
- Flexible attitude towards working individually and as part of a team.
Benefits
tranScrip offers a competitive reward package, which includes:
- Permanent contract of employment.
- Part time contract may be accommodated.
- Competitive base salary.
- Bonus scheme.
- Pension scheme.
- Private health insurance and travel insurance.
- Retail discounts.
- Strong focus on CPD.
- Career progression in a rapidly expanding organisation.
Location
- Remote possible.
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