Director of Medical Affairs, General & Speciality Medicine

We are a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us., Lead an industry leading General & Speciality Medicine (GenMed) medical affairs team, to provide expert strategic input in support of the objectives of the GenMed therapeutic areas, with current focus areas pulmonary hypertension, HIV, cardiovascular and immunology. Hold the overall responsibility for the development, execution and delivery of tactical objectives of Medical Affairs Plans for the GenMed therapeutic areas in UK, in close alignment with Ireland, in alignment with the overall strategic objectives in the UK, and in partnerships as part of the UK Medical Leadership Team. Work within a UK framework in alignment with the direction provided by Regional Medical Affairs EMEAC and the Global GenMed Team, identifying areas of strategic interest within the UK scope, and addressing those with a tactically focused Medical Affairs Plan. Have a healthcare professional-focused approach, developing professional relationships with scientific and clinical leaders in GenMed and supporting
efforts in key strategic areas. These interactions also extend to regulatory bodies, payer groups and key advocacy groups. Lead, on behalf of the UK company, the collaborative relationships with our GenMed partners. Will partner with the EMEAC lead and GenMed Global Medical Affairs and share medical/scientific expertise with your counterparts in region, as well as in other functional areas such as Quality Assurance, Regulatory Affairs, Legal and Marketing in the UK. Will also maintain responsibility for support towards new approvals and regulatory reporting as required. Ensure operational and fiscal excellence in the GenMed medical affairs directorate, in close alignment with the UK Medical Leadership Team. To function in a non-promotional capacity for 100% of the time spent in role.,

• Work in collaboration with the Medical Affairs United Kingdom and Ireland Leadership team (UKILT), the UK GenMed Cross-functional Leadership team, lead the GenMed Medical Affairs Directorate.


• Strategically plan for the implementation of GenMed medicines and utilising the team (and working in partnership with cross-functional teams) to create Medical Action Plans (MAPs) for each key therapy area.


• Deliver, through leadership of the team, tactics in the MAPs to a high standard of medical affairs excellence, and in doing so, seek to administer new capabilities for the team where needed.


• Represent our company medical function as the senior leader for our GenMed portfolio at clinical or scientific meetings or by through direct 1:1, building strong relationships with top tier stakeholders in healthcare provision, academic research, commissioning, NHSE, etc.


• Lead for the UK, working closely with External Affairs, Scientific Policy, to ensure detailed mapping of emerging and evolving UK life sciences capabilities and opportunities to connect these with UK MAPs and global strategies.


• Ensure a detailed knowledge of the company early and late pipeline is developed and maintained and strategic engagement / alignment with discovery, development and search and evaluation teams to understand their needs.


• Undertake advice seeking activities for pipeline medicines and define the potential impact on the patient early in the development cycle.


• Working in close collaboration with the Head of Health Technology Assessment and Outcomes Research, maintain oversight of UK medical affairs Phase 3b and phase 4 (RWD) projects, with matrix leadership of study operations and budget, delivering an inclusive data generation and publication plan.


• In partnership with market access and commercial colleagues, deliver effective horizon scanning activities and HTA submissions. This would include creating access programmes (where appropriate) to deliver medicines earlier to patients.


• Assess directorate team capabilities and operational status to ensure that the team are excelling in meeting UK regulatory and governance frameworks. Working with UKILT ensure directorate members are 'audit' ready e.g. MHRA audits and lead the team during audits.


• In collaboration with the UKILT, support the implementation of on the UK and Ireland (UKI) medical affairs training programme and contributing to its development. In delivering team objectives champion cross functional partnership and dismantle silo working.


• Develop and mentor talent to fulfil their potential, attracting new talent to the organisation and effectively addressing under performance. When appropriate deputise for other medical UKILT members., Business & Financial Acumen - understands and intelligently applies economic, financial and industry data to make business decisions that drive value for our company and our customers.


• Working Across Boundaries - thinks and acts beyond one's silo - bridges boundaries across teams, functions, divisions, geographies, external stakeholders and customers.


• Strategic Thinking - visualizes the way forward, identifying opportunities that add value to the work, to the business and to our customers.


• Project Management - organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines and ensuring on-time delivery.


• Productive Communication - plans and delivers ideas and information to others in a clear and impactful manner.


• Problem Solving - gathers and analyses data and effectively responds to new, complex or problematic situations; creates solutions that drive value for our company and our external stakeholders, incorporating innovative approaches where relevant.


Desired Leadership Behaviours

• Demonstrate ethics and integrity - Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.


• Drive results - Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.


• Focus on customers and patients - Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs.


• Make rapid, disciplined decisions - Make timely decisions at the right level with the right data, and support them once made.


• Act with courage and candor - Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions.


• Build talent - Build diverse talent with the capabilities necessary to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.


• Foster collaboration - Actively listen and seek to understand differing perspectives; work together to achieve the company''s common goals.


Desirable Medical Affairs Competencies

• Healthcare professional/provider, Market & Competitor Insights - ability to develop an understanding of science, medicine, clinical practice and therapeutic areas to address external needs, beliefs and goals and understand market dynamics, unmet medical needs, competitor landscape and trends with the goal of improving overall business and patient outcomes.


• External Stakeholder Engagement - ability to add value to one-time stakeholder interactions (e.g., formulary discussion, pipeline presentations, hcp interactions) and/or identify, build and maintain compliant, long-term, sustainable relationships with external healthcare professionals, stakeholders and key influencers through a variety of relationship-building approaches.


• Subject Matter Expert Engagement - the ability to identify and establish strategic partnerships with medical leaders, scientific leaders, and other external subject matter experts. develop and manage communication plans and engagement strategies for these experts. the ability to act as a single point of contact for these experts to foster an environment that presents our company as the preferred partner of choice.


• Discovery, Development & Lifecycle Knowledge - knowledge of our pharmaceutical business model, including the end-to-end discovery, development and lifecycle management process for products (e.g., pharmaceuticals, vaccines, cosmetics, medical devices, otcs) and understanding of regulatory challenges and constraints on development and commercialization. ability to understand the pharmaceutical landscape (including recent technical innovations, development strategies, the disease environment and unmet patient needs) and its impact on our business strategy.


• Regulatory, Compliance & Risk Management - the ability to understand, effectively apply and comply with internal and external standards (e.g., our policies, standard operating procedures); appropriate ethical, legal and regulatory standards (e.g., pharmacovigilance, GCP); and product promotion on/off label compliance standards. the ability to identify, proactively manage, and mitigate risk to achieve positive business outcomes.


• Disease Area & Product Knowledge - the ability to understand the therapeutic area, ours and competitor products, therapeutic options, and the disease environment as it relates to patient and population characteristics, disease epidemiology, biomarkers, disease pathophysiology, genetic variation, comparative effectiveness, emerging trends, treatment practices, and unmet needs. the ability to establish relationships with scientific advisors and leverage research opportunities across the product lifecycle.


• Medical Research Design & Execution - the ability to understand, oversee, and/or execute the design, planning, and performance of robust and efficient research activities using the appropriate tools, methodologies and processes to generate definitive outcomes. understanding of data collection methods, tools, processes, and quality control standards.


• Medical Program Design & Execution- the ability to understand, organize, and/or execute the design, planning, and performance of expert engagement activities (e.g., expert input, scientific/medical exchange, speaking activities). ability to understand and apply strategic expert utilization planning, business need assessment, compliance obligations, and program effectiveness assessment to expert engagement activities.


• Data Review, Interpretation & Communication - the ability to consolidate and understand data, plan and/ or execute data analyses, summarize and synthesize data and objectively interpret results. the ability to objectively communicate analysis and results in verbal and written terms that can be understood by a variety of stakeholders.
  
  Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career., Medical degree preferred. Pharmacy degree or a higher science degree (i.e. PhD) with significant industry experience, a robust understanding of the therapy area and NHS clinical practice and clear demonstration of achievements.


• Significant industry experience or equivalent experience (with experience in General Medicine being essential).


• High level of knowledge of ABPI Code of Practice and GCP, final signatory status.


• A demonstration of understanding the identification, application and adoption of innovative technologies and processes in the pharmaceutical and/or healthcare delivery environments.


• Proven leadership with a focus on talent development skills.


• Proven relationship building skills with scientific leaders (either in the pharmaceutical industry or healthcare/academic setting).


• Understanding of the wider NHS environment and key opportunities for pharma and the NHS to partner effectively within the scope of the ABPI Code of Practice.



• A strong scientific background in medical or biological science is essential for this role, preferably a GMC registered doctor, GPhC registered pharmacist or has a PhD with significant industry experience, a robust understanding of the therapy area and NHS clinal practice and clear demonstration of achievements. Strong understanding of the National Health Services and National Immunisation Programs in the UK, the UK academic environment and the life sciences community as a whole and how the various aspects operate together. Ability and proficiency in discussing data, policy, health economics and science with senior stakeholders in these areas.


• Confident communicator and strong interpersonal skills with excellent strategic planning and organisational skills. Ability to prioritise work effectively; balancing both long and short-term requirements and be able to demonstrate previous excellent cross functional working. Good working knowledge of Good Clinical Practice (GCP), Pharmacovigilance laws and regulations and the ABPI code of conduct.


• Previous experience from managing teams and can both motivate teams and set a high strategic direction for the team, whilst also developing and managing the team to perform to a high level of capability.


• Having confidence and ability to talking to senior stakeholders across the business, at all levels and to represent the team and the UK and Ireland Medical Affairs team both internally and externally.


• The defining skills therefore, will be well-developed communications skills combined with the ability to strategically plan (across the whole of the lifecycle of a medicine), critically appraise progress, and work towards implementing change with external and internal stakeholders to bring about impactful patient centric objectives., Valid Driving License
  
  Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.