Clinical Operations Lead

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.,

• The role will work in partnership with UK and Ireland (UKI) medical affairs in ensuring the successful execution of local data generation and investigator-initiated studies (LDG & MISP).


• To manage research project managers that will work closely with medical affairs in developing, monitoring, and supporting LDGs and MISPs.


• To contribute to the development and implementation of our data gap analysis workshops with cross functional colleagues.


• To identify, develop and maintain credible relationships with healthcare professionals, suppliers and academic centres and other research partners.


• To demonstrate financial acumen throughout the development, management and on-time delivery of LDGs and MISPs studies.


• To successfully support and ensure publications of LDGs and MISPs.


• To ensure process assurance and audit readiness at all times of all team's activities.


• Advocate cross functional partnership across the business in the delivery of company and team objectives.


• Maintain integrity and ethical standards for the organisation, always acting by example.


• To function in a non-promotional capacity for 100% of the time spent in role., Lead a team in supporting Medical Affairs to undertake the successful delivery of local evidence generation (LDGs and MISPs) through cross-functional working.


• Ensuring process accordance of local evidence generation for Medical Affairs and 'audit-readiness' in collaboration with the Governance and Process Assurance team.


• Develop and maintain professional and credible relationships with the research collaborators across the health care community, scientific experts and academic centres in the management and progress monitoring of LDGs and MISPs.


• Be the local medical point of contact for all LDGs and MISPs execution and support medical affairs and the cross functional team in the timely completion and publication of studies.


• Co-lead on strategy and execution of data gap analysis workshops and the development of LDGs proposals, whilst providing research management support to address prioritised TA's data gaps in an effective and timely manner.


• Demonstrate financial acumen in contract negotiation and research monitoring to ensure alignment with allocated budget and business financial timelines.


• Work across boundaries to think and acts beyond one's silo, and bridge boundaries across teams, functions, divisions and customers to successfully execute LDGs and MISPs.


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


• Identify appropriate suppliers, negotiate contract and navigate studies whilst maintaining transparent and collaborative approach with medical affairs partners.


• Work with the MLT (Medical Leadership Team), LDG/MISP leads and direct reports to plan, setup, execute, and deliver UK studies to forecast.


• Work in partnership with colleagues to facilitate the delivery of data generation activities (LDGs and MISPs), including the identification of suitable research projects, research centres, investigators and innovative methods to generate data.


• Work in partnership with GCTO (Global Clinical Trials Organisation) and PDT (Protocol Development Team) to facilitate research activities.


• Be accountable for tracking all relevant studies including recruitment, milestones, and budget payments.


• Co-chair of the Data Council responsible for business oversight and governance of our local evidence generation activities. Maintain compliance, ensuring that all activities and interactions are conducted in compliance with applicable local, global and national laws, regulations, guidelines, codes of conduct (including but not limited to the ABPI Code of Practice) company policies and accepted standards of best practice., 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.


Desirable core role 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 company's 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 company 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, our company 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., A strong scientific background in medical or biological science is needed for this role as a GPhC registered pharmacist or has a PhD/Masters. Significant experience with MISPs and LDGs is required including experience of audits in these areas. The candidate should be self-assured in their communication and social skills with excellent strategic planning and organisational skills. They should also be able to prioritise work effectively; balancing both long- and short-term tasks and be able to demonstrate previous excellent cross functional working. The candidate will have a good working knowledge of Good Clinical Practice (GCP), Pharmacovigilance laws and regulations and the ABPI code of conduct. The defining skills, therefore, will be well-developed communications skills combined with the ability to strategically plan, critically appraise progress, and work towards implementing change with external and internal stakeholders to bring about impactful objectives., A strong scientific background in medical or biological science is needed for this role as a medical doctor, GPhC registered pharmacist, has aPhD/Masters/Bachelors.


• Significant experience with local evidence generation, including MISPs and LDGs is required including experience of audits in these areas.


• Strong communication and social skills with excellent strategic planning and organisational skills.


• Effective prioritisation, balancing both long- and short-term tasks 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.


• Ability to strategically plan, critically appraise progress, and work towards implementing change with external and internal stakeholders to bring about impactful objectives.


• Leadership skills, ideally with previous management experience to manage, mentor, motivate and performance mange the clinical operations team., 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.