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Immunology Medical Affairs Dir.
Requisition ID: 1805624045W
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, and vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson (J&J). Please visit http://www.janssen.co.uk/ for more information.
Lead a therapeutic area team to develop and execute the medical and scientific strategy for both the current and future pipeline products and indications.
Responsible for medical strategy development and coordination of activities in their respective Therapeutic Area.
Guide the development of integrated data generation plans by the Medical Leads and the implementation thereof, including medical assessment and approval of clinical study protocols on a local level. Managing 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.
Shape and influence EMEA strategies, plans and tactics to ensure they reflect the needs of the UK market.
Represents the company as a key clinical expert in front of leading medical experts, professional associations and institutions in their therapeutic area. Interacts closely with commercial and market access counterparts on the disease area level and is responsible for the implementation of aligned medical education events.
Ensures all individuals, strategies and processes are in compliance with all relevant guidelines and regulations.
- Clinical and scientific leadership of their Therapeutic Area and all relevant products within. They manage a team of Medical Leads including their MSLs, Medical Advisors and the Medical Education Managers.
- Approval of clinical study protocols on a UK level based on evaluation of relevant medical research questions for investigation in interventional and non-interventional studies, managing Study Responsible Physicians and work as a Study Responsible Physician. Assessment of study results from a clinical perspective and releasing of final study reports.
- Clinical evaluation of side effects of medicinal products, responsibility for issue management and medical safety issues and responding to external medical/scientific requests about Janssen products
- Medical evaluation of medicinal products, which are pending licensing and provision of the medical expertise for the benefit assessment of Janssen medicinal products by NICE and the NHS
- 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 line management for the senior Medical Advisors and Medical Advisors as well as Medical Education Managers in their team, including employee/talent development
- Ensures medical representation of the company and integrates requirements of the local healthcare market into the global research and development programme
- Establishing/developing and maintaining doctor-to-doctor contact to form a Key Opinion Leader Network including involvement in professional associations, healthcare policy organisations etc. in order to establish and retain a medical/scientific partnership at the highest level of expertise
- Establishing and continuously managing a professionally-acting, compliant and effectively-collaborating team; recognition of employee potential and goal-driven, bespoke development and encouragement for employees
Experience and Qualifications
- Accredited physician with either a specialty degree or several years of experience in the therapeutic area.
- Doctorate degree or PhD are a plus
- professional experience in hospital or practice within the therapeutic area plus professional experience as Country Advisor/Manager or in a comparable position
- several years of line management leadership experience
- Experience in design, planning and conduct of clinical research protocols
- Regulatory, Health Economic or/and statistical methods knowledge and experience are a plus
- MBA or relevant business expertise or experience are a plus
- Fluent English is absolutely essential
- Has the ability and the mandate to shape the external environment and shows a superb aptitude in partnering relevant external and also all internal stakeholder in the Therapeutic Area especially the Market Access and Marketing and Sales colleagues
We respectfully request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Janssen-Cilag Ltd, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)