Location of role Gaithersburg, MD, Conshohocken, PA, or Remote
Department Medical Affairs - Global
Key Responsibilities MAIN PURPOSE OF JOB
The Director of Medical Information will be responsible for maintaining and optimizing the global operations of the Medical Information team and contact centers including strategy, processes, and content support library as well as developing and supporting the answering of queries for Immunocore, supporting current products and pipeline. The Director of Medical Information will lead and be accountable for timely updates and balanced clinical data dissemination in standard response documents, verbal responses, and FAQ development in conjunction with the Publication, Capabilities, and Clinical teams as needed. The MI Director will maintain oversight of medical information outsourced services and ensure alignment with medical affairs departments: publications, congress planning, medical science liaisons, engagement with the HCP community, and supporting the Commercial organization in appropriate capacity.
The Director of Medical Information will also be accountable for the continuous improvement and mobilization of Global Medical Information program and processes including creation and update of medical library and support tools, Veeva platform items (i.e. MIRF and LMR responsibilities) and accountable for insight gathering and sharing among the medical and clinical team as well as other internal stakeholders.
The Director of Medical Information will play a key role in developing and fostering internal cross-functional relationships along with appropriate support with the healthcare community including academic, institutional, and governmental authorities, which may include medical support to patient organizations. The Director will continue to ensure working in a compliant manner in the development and review of medical content. This content will align support of Immunocore global medical affairs support.
The Director of Medical Information will provide support to intellectual property and legal activities with Business Development colleagues as requested.
KEY RESPONSIBILIITES
Medical and Personal Leadership:
Lead the oversight of the MI call center(s) that cover the necessary geographies, aligning with and integrating standards, process, and technology with overall strategic program planning. Activities include MI inquiries management, medical writing, and other day-to-day activities including responding to triaged inquiries on global scale. Periodic reviews and quality assessment to ensure high-level performance.
Maintain and cultivate the implementation and update of Medical Information processes related to scientific exchange, medical information/call center operations, insight gathering and processing, and ensure alignment with medical affairs, corporate communications along with other externally facing internal Immunocore/partner stake holders.
Suggest or identify changes and improvements to MI information process and templates to improve quality, efficiency.
Responsible for training of contact center staff and quality review sessions with MI contact center. Ensure call center activities to meet needs and standards of Immunocore.
Plan and staff MI booth at targeted medical congresses; medical support at key medical conferences with activities including booth staffing and material review and initiation. Assist in med affairs strategy for upcoming congresses.
Develop and maintain Medical Information materials including standardized response letters, FAQs and other applicable scientific materials.
Serve as medical reviewer and provide accurate medical and scientific input to promotional/medical review committees.
Collaborate with Safety and QA on the timely processing of post-marketing adverse events and product quality complaints.
Develop and refine insight tools to communicate insights to leadership and business partners to identify and trend data inputs.
Diligently manage MI contact center budget. Assist in the annual global strategic/operational Medical Information planning process and budget oversight.
Liaise with global partner organizations to support local/regional medical information activity. Serve as key intermediary with partner organizations for resources and cross functional medical information excellence.
Provide support to key medical information-related activities. Knowledge of FDA, EU and ICH guidelines governing MI in post-marketing products.
Develop an over-arching strategy for Medical Information focused on MI launch preparation and execution, third party MI management with support and alignment within broader Medical Affairs and corporate strategy.
Develop, manage and update relevant Medical Information SOP(s)
Develop and maintain, in a self-driven manner, outstanding knowledge of immuno-oncology and relevant disease areas
Education and Communication:
Develop and execute the global Medical Information pre-launch and commercialization plan in various countries and ongoing coordination with third party providers to ensure high-level execution and planning that are aligned with corporate objectives
Ensure that all interactions and activities adhere to corporate and healthcare compliance guidance in all activities, including those related to scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information. This will include annual preparation and execution of Sunshine Act planning or other compliance requests made by legal or regulatory authorities.
Act as an initial point of contact escalation point for enquiries from the call center following triage. Should available resources need to be developed, serve as responsible party to ensure completion of non-standard requests.
The Director Medical Information must have regular and continual training relevant to the role of Director/management within Medical Affairs or Medical Information. This training will also include specific aspects of product identification and avoidance of falsified medicines entering the supply chain.
Strategically align medical information assets with other medical affairs resources to ensure delivery of high touch customer-focused approach.
Ensure proper communication and reporting to country-specific allied partners to ensure drug information officers are aligned with MI related activities.
Insights Gathering and Actions:
Design, implement and synthesize medical insights gathering processes, disseminate insights to organization to drive strategy and highlight opportunities that impact strategy
Monitor inquiries for trends and insights and report to relevant internal stake holders
Report KPIs to internal stake holders to ensure operational excellence and high-quality service
Research/Medical Affairs:
Support/Assist the Medical Affairs team to provide strategic medical input to support clinical development activities.
Evaluate, contract and manage all agencies supporting Medical Information activities
Other Medical Affairs responsibilities as assigned
Experience & Knowledge
At least 10+ years of experience, including 5 years of management level in the biotechnology or pharmaceutical industry, globally
Therapeutic area experience in Oncology, Immunotherapy, and melanoma compatible with current pipeline highly desirable
Experience building, leading and support Medical Information team within the context of broader Medical Affairs organization, with the network to leverage to attract external talent to the organization
Experienced record of working cross functionally on strategic planning, as well as creation of a Medical Information Life Cycle Management plan is required
Experience with full lifecycle development and medical support of successfully marketed biotechnology or pharmaceutical products
Expertise in managing outsourced medical information and writing groups to ensure high quality output and timely responses to ensure accurate and timely scientific exchange. Experience in managing multiple priorities as well as multiple vendors to ensure completion of all work in a timely manner
Working knowledge of FDA, EMA and other relevant international regulatory and legal requirements
Effective communication skills with the ability to effectively present complex medical information, including the ability to communicate with knowledgeable lay audiences
SPECIFIC BEHAVIOURAL ATTRIBUTES
Candidates should have the capability for strategic thinking and planning along with operational skill and tactical experience related to clinical research and marketing support activities
Ability to work across multiple functions and to be effective in a matrix environment evidenced by outstanding interpersonal skills, and the ability to collaborate with other groups
Able to anticipate challenges and devise strategies for success
Exhibit high motivation as a self-starter to analyze problems and recognize the key issues that need action and identify options to resolve
Innovative, flexible, with a biotech mindset
Highest levels of ethics and integrity
Education & Qualifications
Advanced terminal science degree (MD, PhD, PharmD, PA, NP)
The “job holder” must have regular and continual training relevant to the role of “Director Medical Information-Global Medical Information”
Training will also include specific aspects of product identification and avoidance of falsified medicines entering the supply chain.
Ability to travel up to 10% of the time.
About the Company Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.
Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.