Associate Director, Medical Affairs

Job description

**This is a remote opportunity with occasional travel, estimated at 20%.** At Kaléo, our way is not to seek to be like others, but rather to passionately pursue meaningful and innovative solutions for patients. We believe all people should have access to the innovative healthcare products and solutions that empower each of them to live fuller, bolder lives. The **Associate Director, Medical Affairs** serves as a scientific leader and subject matter expert within Kaléo’s Medical Affairs team. The position independently leads defined Medical Affairs workstreams encompassing key thought leader engagement, congress scientific activities, Medical Affairs booth strategy, scientific communications, publications, literature surveillance, insight generation, and medical inquiry support. The Associate Director translates scientific evidence and stakeholder insights into actionable recommendations that advance Medical Affairs strategy and provides trained backup support for selected Pharmacovigilance, Medical Information, and Product Complaint activities in accordance with established procedures. This role combines external scientific engagement with visible ownership of high-value Medical Affairs programs. As Associate Director, Medical Affairs, you will help advance scientific understanding within the healthcare professional community, expand organizational capacity for congress activities and evidence communication, and provide practical scientific leadership across the product lifecycle. You will have the opportunity to support potentially life-saving products while working within a passionate, purpose-driven culture and a highly collaborative, close-knit team committed to excellence. **As the Associate Director, Medical Affairs you will:** - Serve as a subject matter expert within Kaléo, translating clinical evidence, stakeholder insights, and emerging scientific developments into strategic recommendations that advance Medical Affairs objectives. - Develop and maintain compliant relationships with KTLs and other external scientific experts; plan and conduct scientific exchanges, and support development and execution of congress meetings, advisory boards, roundtables, consensus initiatives, and other engagements aligned with Medical Affairs strategy. - Develop KTL engagement plans and objectives, interaction planning, documentation of insights, and appropriate follow-up in partnership with Medical Affairs leadership. - Provide Medical Affairs scientific coverage for national and selected regional congresses, including program assessment, session prioritization, coverage plans, KTL meeting preparation, scientific and insight capture, and timely post-congress readouts with implications and recommended actions. - Lead the scientific execution of Medical Affairs booths, including educational strategy, content development, onsite scientific exchange, handling or routing of medical inquiries, insight capture, and post-congress reporting; partner with the Manager, Pharmacovigilance & Medical Affairs Operations on logistics, vendors, contracts, and budget administration. - Lead or support the development and maintenance of scientific communications, including medical education materials, congress resources, scientific presentations, standard response letters, FAQs, and other non-promotional materials. - Support publication activities, including publication planning, literature reviews, abstracts, posters, manuscripts, white papers, and review through applicable publication governance processes. - Conduct literature surveillance and synthesize relevant scientific, clinical, safety, and competitive developments for internal stakeholders; identify potential implications for Medical Affairs strategy, evidence generation, education, and stakeholder engagement. - Lead or support the aggregation and analysis of insights from KTL interactions, congresses, Medical Affairs booths, advisory boards, Medical Information, surveys, and research activities to help identify evidence gaps, educational needs, stakeholder barriers, and strategic opportunities. - Represent Medical Affairs on cross-functional teams and provide scientific expertise to internal stakeholders, including Regulatory, Quality, and Commercial colleagues, as appropriate. - Serve as a trained, designated backup for defined Pharmacovigilance, Medical Information, and Product Complaint activities, including Medical Information call center oversight, review or escalation of medical inquiries, identification and escalation of reportable safety information, and medical assessment of selected product complaints. - Perform other duties and responsibilities consistent with the scope and level of the position, as assigned. **A successful Associate Director, Medical Affairs will have:** - Strong scientific and clinical acumen, including medical terminology, clinical study design, biostatistics, evidence appraisal, and interpretation of clinical and real-world evidence. - Ability to critically evaluate and synthesize complex scientific, clinical, safety, and technical information and translate findings into balanced, actionable recommendations. - Demonstrated scientific writing and communication capabilities, such as development of medical education materials, evidence summaries, abstracts, posters, manuscripts, presentations, and other scientific communications. - Working knowledge of current publication standards, copyright requirements, scientific exchange principles, and laws, regulations, industry guidance, and company requirements applicable to Medical Affairs. - Ability to build credible, compliant relationships with KTLs, healthcare professionals, and other external scientific experts. - Strong scientific presentation skills and the ability to tailor complex information to scientific, executive, and cross-functional audiences. - Strategic thinking, sound judgment, and the ability to connect evidence and stakeholder insights with Medical Affairs priorities. - Demonstrated cross-functional collaboration and influence while maintaining appropriate Medical Affairs independence. - Strong project and program leadership, including the ability to manage competing priorities, complex workstreams, and time-sensitive deliverables. - Ability to aggregate and synthesize insights to identify evidence gaps, educational needs, stakeholder barriers, and strategic opportunities. - Strong quality, compliance, and risk awareness, including recognition and escalation of safety, product quality, and compliance information. - Accountability, adaptability, integrity, discretion, and commitment to continuous improvement. **To be considered for the position, you must have:** - Advanced scientific or healthcare degree, such as a PharmD, PhD, MD, DO, or equivalent relevant degree. - Four or more years of relevant pharmaceutical experience preferred, including experience in Medical Affairs. - Working knowledge of U.S. requirements and industry standards applicable to Medical Affairs, scientific exchange, pharmacovigilance, Medical Information, and product complaints. - Prior Pharmacovigilance, Medical Information, or product complaint experience preferred; ability to complete role-based training and serve as designated backup for defined activities is required. - Ability to critically evaluate clinical and real-world evidence, assess references, synthesize complex information, and communicate balanced conclusions to scientific and non-scientific audiences. - Strong organization, stakeholder management, presentation, and written communication skills. - Ability to work independently, manage multiple priorities, exercise sound judgment, identify and escalate risk, and collaborate effectively in a lean, cross-functional organization. - Experience in KTL engagement, scientific exchange, congress planning or coverage, and development of scientific communications preferred. - Ability to travel overnight up to 20%, including attendance at scientific congresses and external stakeholder engagements; occasional evening or weekend work may be required in connection with congresses. **The anticipated base salary range for this position is $150,000 to $180,000. Final compensation will be determined based on factors including experience, education, skills, and geographic location. This position is also eligible for an annual bonus and comprehensive benefits.**