Medical Lead - Immunology
- Optimise brand/therapy strategy as a core member of relevant CVTs, contributing medical input for current and future licence indications and feeding UK requirements to EMEA and global teams
- Contribute to, and execute, the 3-5 year Therapy Area strategy and overall medical brand plan for specific current assets and future pipeline assets
- Lead the development and delivery of integrated Evidence Generation and Medical Education strategies and other activities within the medical brand plan
- Lead and develop a high-performance and motivated TA medical team and maintain succession plans to meet current and future needs of the business Not Expected to: Describes the outputs NOT expected from this role to help clarify the distinction between different levels. Each time another section of this profile is completed, refer back to this to ensure nothing has been inadvertently added that was previously excluded.
- Interact with press or media
- Create or provide medical information standard letters to external customers or answer medical information questions directly to KOLs.
- Monitor Investigator Initiated Studies (IIS)
- To be the main contact for HCPs who are not KOLs
- Be a final signatory for Director’s route sign off unless specified for particular items Key Role Activities This section details the main activities that fulfil the role purpose statement. It should not cover every single possible activity but focus on the CRITICAL activities that produce the outputs as defined in the role purpose. Activities statements MUST include a verb and avoid the passive sense e.g. “to be aware of” as this cannot be measured.
- Drive and support direct reports to deliver the projects and tactics within the medical brand plan providing general and technical advice, coaching, conducting performance reviews and managing team development plans
- Foster a working environment within the medical team that nurtures open communication, high performance, diversity and inclusion, compliance and a positive work-life balance
- Monitor and communicate team performance to team and management
- Contribute to the development of the MAF strategy for allocated therapy area based on interactions with and input from CVT and drive the team in its delivery of agreed projects and tactics
- Lead development of brand specific evidence generation and medical education plans
- Feedback insights from customers to contribute to cross-functional (marketing, medical, outcomes research, BI and communications) brand team strategies and highlight key aspects of clinical data so that they form the basis of key marketing messages
- Build understanding of company, global and regional TA and individual product strategy together with local Business Unit strategy
Therapy area knowledge
- Be aware of the latest scientific and clinical advances and developments within the pharmaceutical industry in relevant therapy areas by reviewing summarised literature searches, analysed clinical papers and attending conferences, courses and other events.
- Monitor competitor promotional and scientific activities to understand their ongoing strategies and assess their compliance with the Code of Practice.
- Synthesize therapy knowledge and data to ensure therapy area strategy is aligned and course correct where necessary
- Develop and maintain positive relationship with Key Opinion Leaders
- Meet with key customers and researchers on a regular basis through 1:1 and group meetings, conferences etc., to:
- Gather information and insights on therapy area (including Competitor landscape) and customer medical and scientific needs
- Exchange disease area knowledge and opinions in order to understand emerging opinions
- Increase customer understanding about Janssen products and processes (e.g. clinical data, IIS, clinical trials, compliance processes), according to their expressed interests and needs and to seek their advice on the development of our products.
- Deliver scientific and medical content at medical advisory boards; chair/co-chair such meetings
- Be the point of contact for investigator-initiated studies (IIS) and manage such studies in collaboration with GCO. Sign off on the Safety Profile of such studies
- Interact with patient advocacy groups and support appropriate initiatives e.g. responding to clinical interest, gathering insights.
- Engage with government bodies (e.g. NICE, SIGN, SMC, AWSMG) to ensure our products are presented in such a way that all appropriate patients benefit from them and collaborate with colleagues (HEMA) to provide data so that relevant guidelines can be developed
- Represent Janssen to industry and other professional groups/bodies at relevant meetings.
- Be a medical representative at, and contribute to, CVT to understand, shape and execute brand priorities and support the company strategic objectives and maintain strong working relationship with all key CVT members.
- Build and maintain a network with Global and EMEA Medical Affairs, R&D, GCO, SKM, Medical Education and marketing colleagues.
- In line with the ReCAP process, review and amend study proposals to ensure clinical trials are aligned with Global, Regional and local commercial strategies
- Take role of Study Responsible Physician.
- Lead the medical team in developing compliant materials, aligned to ABPI and HCBI guidelines
- Have primary responsibility for copy approval of TA materials (can delegate to Medical Advisors)
- Lead MAF engagement with CVT and other internal and external stakeholders to ensure compliance with the necessary Codes of Practice and Laws governing the promotion and sale of medicines within the UK and Ireland.
- Maintain expert knowledge of all relevant UK specific differences, for example applicability of the ABPI Code of Practice and the implications for marketing, clinical trials and medical education and communicate to Global and EMEA teams
- In the event of any potential breaches of the Code of Practice, lead the complaints procedure to defend company position; prepare response for review by TAD and sign off by Medical Director, engage in inter-company dialogue and provide representation at PMCPA hearing if necessary.