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Executive Director, Head of Medical Operations
1 month ago
The Head of Global Medical Operations & Communications is a key leadership role, encompassing a unique combination of both scientific and operational expertise, managing diverse cross-functional teams across Global Medical Affairs, and ensuring harmonization with Global Business Excellence and Operations (BE&O).
Main Responsibilities & Accountabilities
• Oversee all operations and responsibilities of the Medical Information function with oversight of global strategy and execution of deliverables for marketed and in-development products including ensuring final medical sign-off for all standard response letters, sales training, dossier creation and maintenance, Compendia reviews, vendor and after-hours management, and field medical resources for scientific exchange (i.e., slide decks, managed care materials, digital resources). Responsible for the communication with global partners to have awareness of global MI generated response documents and localize as appropriate. Collaborate with cross functional teams (i.e., pharmacovigilance, product quality) to ensure adherence to CSL policies related to AE and Product Complaint reporting requirements.• Ensure accountability of the Medical Information team and therapeutic medical directors to provide final medical sign-off on all promotional and non-promotional resources in collaboration with Legal, Compliance, and Regulatory. Responsible for supporting escalation to country level PRC governance as appropriate.• Lead the Operations governance committee for global grant programs including Independent Medical Education (IME), Investigator Initiated Studies, Publications grants and material transfer agreements. Serve as a voting delegate to head of global medical. Responsible for adherence to compliance processes, in collaboration with Global Commercial Operations, by all medical affairs leaders across all therapeutic areas country affiliates globally, as appropriate.• Ensure development of key process and SOPs (e.g. Fair Market Value, Advisory Board planning and execution, publication practices) to ensure compliant standardization of processes throughout the Medical Affairs Global Organization. Implement training within CSLB and sharing of such across the Medical AffairsCSL Limited Enterprise.• Lead the inspection and audit readiness plan and process for global medical affairs. Ensure all SOPs and WI for all of MA (in collaboration with LQO, Compliance and GCO) is up to date and assess need for any new WI and SOPs. Lead the creation and maintenance of a role-based core curriculum across medical affairs globally and ensure cross functional SOP assignments are appropriate.• Serve as the Medical Affairs systems Lead to identify and leverage digital innovation to optimize MA communications to meet CSL 2030 strategy. Partner with I&T leadership in identifying and/or launching key digital platforms and providing oversight of all MA systems (e.g., Veeva [CRM, Promomats, MedComms], CyberGrants, Pubshub) to optimize scientific support and exchange. Lead all training and uptake of these systems by global medical organizations. Lead the development of consistent process to support the systems across global for all medical programs.• Partner with I&T to lead the development and upgrade of Medical Affairs website to enhance communication and utility for HCPs. Ensure continuous optimization of this website to improve connectivity with improved features (e.g., MI chat function, digital resources to showcase MoA of products) and appropriate resources to support education of emerging products.• Serve as the MA lead to work collaboratively with Finance partners on HLR 1 and HLR 2 budget. Lead the quarterly forecast for all MA and ensure management of MA OPEX budget within target. Maintain operational excellence in budget management standardization across all MA.• Identify appropriate key performance indicators for MA. Collaborate with ABC to lead the development and maintenance of global medical dashboard to share key metrics and insights with executive leadership.• Work collaboratively with Learning and Growth to create and execute developmental training plans for global medical for talent retention and growth. Support the execution of all country affiliate intern and fellowship programs.• Oversee and effectively manage direct reports in areas that include but are not limited to the following:• Recruitment, selection, and retention of talent• Annual objective setting• Mid-year and end-year performance reviews• Provide and assure completion of appropriate training• Mentorship• Establish a productive and motivating work environment• Coach and counsel as appropriate• Individual professional growth & development• Manage, direct, and evaluate performance on an ongoing basis. Providing timely constructive feedback to ensure quality of work meets or exceeds performance expectations• Assure work is completed in a customer-focused, competent, and compliant manner
Assure prudent and compliant use of travel, expense, and company car resources.
Qualifications & Experience Requirements
• MD or advanced degree (e.g., PharmD, PhD) with 15+ years of pharmaceutical/biotherapeutics industry experience; second degree in business a plus.• Medical affairs/Clinical experience, preferably in a specialty relevant to CSL’s therapeutic areas/products• 8+ years of Executive Medical Affairs Leadership experience• Experience building and leading cross-functional teamin a global matrix organization• Strong capabilities in clinical research, evidence generation and scientific engagement• Influential leader who builds relationships across stakeholder types• Executive presence with ability to communicate complex data persuasively and relate study results and knowledge of therapeutic area to industry-specific applications• Strong working knowledge across multiple therapeutic areas and products, Strong Regulatory and medical information communications knowledge and experience
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring
