Therapeutic Area Director, Therapeutic Area Medical Affairs Lead
Therapeutic Area Director, Therapeutic Area Medical Affairs Lead (Vaccines)
As a Director you will play a key role and will be a member of the GSK Pharma Research & Development Unit. The role reports directly into the VP Medical Director, Spain.
Responsible for all medical & scientific matters (both Clinical and Commercial-related) regarding the product/compound/disease area(s)including adequate Medical Governance and compliance with Pharmacovigilance & Risk Management requirements.
This position is a key one to the Business in medical matters, in order to ensure best business output results from scientific data generation and use. To help coping with the dual Clinical and Commercial scope of the role, the incumbent will have several medical advisors/project managers.
The role involves ensuring that Medics within the team develop as appropriate the necessary capabilities with regards to Clinical Development and Medical Affairs functions and provide coaching of direct reports.
Within GSK Spain, director will work with the relevant Business Unit (s), Market Access, Governmental Affairs and Regulatory Affairs Dept colleagues. A key function of this role will be the GSK Spain Med Dept representative in those European Teams (e.g. European Medical Networks) dealing with the compounds/products under his/her responsibility.
Jobholder will build a solid team with his/her Commercial counterparts and will devote a significant part of his/her time to European/Global (or corresponding teams) tasks.
- Full oversight of the LOC, European and Global strategic needs of the Medical Affairs Department under his/her responsibility, directly and/or through his/her team, both from the Clinical and Commercial perspective.
- Accountable for Med Dept contribution for all programmes under his/her responsibility. Will be the Med Dept representative in European and Global Teams. This involves contributing to the strategic plans and campaigns originated in global/region and ensuring appropriate compliance with relevant internal and external procedures, regulations and codes, being responsible for the development and execution of innovative Medical affairs strategies and plans that clearly support GSK development of medicines of value for patients and customers.
- Will be ultimately responsible for the Medical Governance of the Area-related medical activities, both in terms of Development and Med Affairs, being responsible for the final signoff of the copy approval process.
- Active member of the pre-launch local business/project teams. In such role, will provide best medical input to other stakeholders (eg. Regulatory, Commercial, BD, etc.).
- Responsible, in cooperation with the Clinical Operations Director, for ensuring cross alignment in activities between the ClinOps and Medical Affairs staff including training, protocol advise and scientific engagement and the successful execution of GSK trials, according to LML role (only for Vx)
- Ensuring correct design, conduct and report of all compound-related scientific studies (e.g. epidemiological studies), as agreed with the relevant units, and approved by ISS/SCS Management, within the approved study budget: - *Contribute to global phase IIIb/IV clinical development strategy as part of brand and product planning. *May act as a Medical Responsible for specific programmes/projects, including study SAEs review to detect and to manage sentinel events properly. *Agreement (with R&D, Pharma Europe) and control of study budgets (with the assistance of the Finance Analyst in the ClinOps team) of ISS/SCS and local studies. *Support the interactions with Research Ethics Committees and AEMPS (Spanish Medicines Agency) on CTA and clinical trials issues as well as potential European Regulatory assistance (eg. when the AEMPS acts as rapporteur/co-rapporteur). *Provide support in the compilation of data from Therapy Area for submission to the Ministry of Industry’s ‘Profarma’ plan.
- Ensure constant and scientific support of his/her TA organization, to the Market Access and VEO teams including training and cross collaboration.
- Ensure liaison with patients as dictated by GSK polices in agreement with the GSK Patients Organizations.
- Accountable for the Scientific engagement activities developed in her/his responsibility area. He/She manages a team of Medical Managers, LMLs (only for Vx), Scientific Advisors / Medical Advisors, Project Managers and MSLs with a view to create a high-performance organization. Be responsible for the development needs of their teams and for stablishing and meetings resourcing needs in close liaison with Human Resources, Finance and commercial partners.
- The incumbent would be responsible for designing, planning, and leading/co-ordinating Therapy Area activities (within his/her team, with R&D and with the Commercial organization) as to ensure that a consolidated opinion (medical & commercial) is voiced to GSK and externally. He/She will foster interactions with KOLs, Scientific Societies, NGO and other external bodies/experts, as appropriate in the full spirit of the GSK Code for Scientific Engagement. Conduct peer to peer robust scientific dialogue with external experts, selected according to their relevant experience and uses this to generate insights and secure advice that informs GSK development of medicines of value, for the ultimate benefit of patients.
- Advanced Degree (Ph.D.) in a scientific, medically related or life science field.
- MD preferred.
- Extensive experience in Pharma Ind. Medical Dept (>10 yr), with a proven commercial acumen and a scientific-driven mentality. Experience include both Clinical Development and Medical Affairs, preferably in more than one Therapy Area.
- Leadership and managerial experience with direct reports (>2 years).
Scientific & Clinical Expertise
- Knows the disease, its prognosis and its impact on patients’ lives from first presentation through typical treatment pathways.
- Is up to date with scientific/ clinical advances and anticipates their impact on disease management and guidelines.
- Critiques scientific data with confidence, including the appropriateness of the research methodologies used.
- Understands unmet medical needs in that therapeutic area.
• Product & Therapeutic Area Expertise
- Has in-depth knowledge of GSK products in that area including the Phase I-IV studies completed and planned.
- Understands the populations and endpoints selected and the claims they support.
- Understands the risk: benefit profiles of GSK and competitor products in each therapeutic class and patient population.
- Knows the GSK and competitor pipelines and the desired positioning of new medicines/ indications in future guidelines.
• Evidence Generation
- Anticipates the information needs of payers, regulators and prescribers throughout the life-cycle of the products.
- Demonstrates strong business acumen and integrative thinking to address identified data gaps and optimise strategic plans.
- Designs/ informs studies that will deliver the data required to make evidence-based treatment decisions.
- Utilises study methodologies and approaches that clearly demonstrate the value of our products in defined populations.
• Value & Access
- Integrates information from multiple sources to communicate a compelling value proposition that supports the positioning of GSK product(s) in formularies and guidelines.
- Understands the business, political and health policy environments and anticipates changes that may impact future evidence needs.
- Develops plans to expand market access for appropriate populations driven by unmet needs and robust scientific data.
• Medical Governance
- Holds self and others accountable for ensuring compliance with required GSK Policies/ Standards and external regulations.
- Applies good judgment: seeks solutions that meet business needs whilst remaining compliant with GSK Values and principles.
- Understands the Medical Governance Framework and escalates areas of concern appropriately for clarification and resolution.
- Establishes appropriate oversight and monitoring.
• Operational Excellence
- Designs, delivers and informs high quality medical plans, activities and materials that are on time and on budget.
- Applies metrics effectively to ensure delivery and to communicate progress to stakeholders.
- Enhances business performance through simplification and continuous process improvement.
• Impactful Communications
- Is skilled at communicating with external medical audiences through multiple channels (including digital).
- Translates complex science into messages that resonate and / or articulates the value of our products clearly and concisely.
- Responds to questions confidently and appropriately using expert knowledge and sound judgement.
• Engagement Skills
- Has meaningful external engagements that build insight, understanding and trust – enabling effective partnership.
- Plans and executes engagements effectively using the Medical Engagement Framework.
- Uses insight gathering questions and clinical facilitation skills to ensure effective 2-way dialogue both 1:1 and 1:Many.
• Excellent knowledge of written and spoken English and Spanish.
• Excellent organization skills, ability to prioritize.
• Flexible and proactive working attitude.
• Effective team member with good interpersonal skills.
• Attention to detail.
• Demonstrated ability to organize and facilitate/conduct tactics.
• Ability to understand and follow policies and procedures.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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