UK Medical Therapeutic Area Lead, Rare Diseases & Neurology
A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a UK Medical Therapeutic Area Lead, Rare Diseases & Neurology. This company boasts an extremely impressive portfolio of therapies for prostate cancer, neuroendocrine tumours, and renal cell carcinoma, along with medicines for cervical dystonia, hemifacial spasm, and paediatric lower limb spasticity. Based in the company's UK office, this role is an exciting opportunity to bring experience and dedication to this internationally successful company.
- Lead a therapeutic area team to develop and execute the medical and scientific strategy for both the current and future pipeline products and indications.
- Accountable for both the medical strategy and tactical plan development with co-ordination of activities in their respective therapeutic Area.
- Guide the development of integrated data generation plans by their relevant therapeutic area team and the implementation thereof, including medical assessment and approval of clinical study protocols on a local level and relevant Investigator sponsored trials.
- Manage Study Responsible Physicians, (can work as a Study Responsible Physician themselves) and evaluate product aspects that are relevant to drug safety from a clinical perspective.
- Represent the company as a key clinical expert in front of leading medical experts, professional associations, and institutions in their therapeutic area.
- Interact closely with commercial and market access counterparts on the disease area level and is responsible for the implementation of aligned medical education events.
- Work with relevant GMA medical teams to shape and influence strategies, plans, and tactics to ensure they reflect the needs of the UK market.
- Ensure all individuals, strategies and processes comply with all relevant guidelines and regulations.
- Provide clinical and scientific leadership of their Therapeutic Area and all relevant products within.
- Manage a team of Medical/scientific advisors and field based MSLs.
- Focus strategy and activities around the key medical affairs pillars of
- Scientific Exchange
- (ii) Data Generation
- (iii) Insights Generation
- (iv) Customer advocacy and relations
- (v) Compliance to relevant standards (ABPI Code of practice, ICH-GCP, SOPs and any other relevant standards)
- Approve clinical study protocols on a UK level based on evaluation of relevant medical research questions for investigation in interventional and non-interventional studies, manage Study Responsible Physicians, and work as a Study Responsible Physician.
- Assess study results from a clinical perspective and releasing of final study reports.
- Clinically evaluate side effects of medicinal products, take responsibility for issue management and medical safety issues, and respond to external medical/scientific requests about products.
- Medically evaluate medicinal products that are pending licensing and provide medical expertise for the benefit assessment of company medicinal products by NICE, SMC, AWMSG, MHRA, NHS and any other relevant external bodies.
- Responsible for budget and resource allocation within the medical field in close consultation with the Finance team and based on approved business plans.
- Responsible for the line management for all therapy area medical team consisting of medical/scientific advisors and medical science liaisons, including employee/talent development and retention of key talent.
- Establish/develop and maintain doctor-to-doctor contact (and other relevant therapy area HCPs) to form a Key Opinion Leader Network and plans, including involvement in professional associations, healthcare policy organisations.
Skills and Requirements:
- Accredited physician or UK registered Pharmacist, with either a specialty degree or several years of experience in the therapeutic area.
- Ideally a Life Science graduate with higher degree (MSc, MBA, PhD, or similar).
- Professional experience in hospital or practice within the therapeutic area, plus professional experience as Country Advisor/Manager or in a comparable position.
- 5+ years of line management leadership experience.
- Prior medical affairs experience (ideally 5+ years) in the pharmaceutical industry, ideally with prior experience within the therapeutic area.
- Experience in design, planning, and conduct of clinical research protocols.
- Proven track record in producing publications for research undertaken (posters, presentations, and publications).
- Regulatory, Health Economic, or/and statistical methods knowledge and experience are a plus.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Edward White at +44 203 854 2622 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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