医学事务高级主任
Associate Director, Medical Affairs
这是一项远程工作，偶尔需要出差，预计占20%的时间。
在Kaléo，我们的做法不是去模仿他人，而是热情地追求对患者有意义的创新解决方案。我们相信每个人都应该能够获得创新的医疗产品和解决方案，使他们能够过上更加充实、勇敢的生活。
医学事务主管在Kaléo的医学事务团队中担任科学领导者和专业领域专家。该职位独立领导定义好的医学事务工作流，涵盖关键意见领袖接触、会议科学活动、医学事务展位策略、科学传播、出版物、文献监测、洞察生成以及医学咨询支持。医学事务主管将科学证据和利益相关者洞察转化为可执行的建议，以推进医学事务战略，并根据既定程序为选定的药物警戒、医学信息和产品投诉活动提供培训后的支持。
这个职位结合了外部科学参与和对高价值医学事务项目的可见责任。作为医学事务主管，您将帮助推动医疗专业人员社区内的科学理解，扩大组织在会议活动和证据传播方面的能力，并在整个产品生命周期中提供实际的科学领导。您将有机会支持可能挽救生命的的产品，同时在一个充满激情、有使命感的文化氛围中工作，与一个高度协作、紧密团结的团队一起致力于卓越。
作为医学事务主管，您将：
- 在Kaléo内部担任专业领域专家，将临床证据、利益相关者洞察和新兴科学进展转化为推进医学事务目标的战略建议。
- 建立并维护与关键意见领袖和其他外部科学专家的合规关系；计划并开展科学交流，并支持会议、顾问委员会、圆桌会议、共识倡议及其他符合医学事务战略的活动的开发和执行。
- 开发关键意见领袖接触计划和目标，制定互动计划，与医学事务领导合作记录洞察并进行适当的后续跟进。
- 为全国范围内的医学事务科学事务提供支持。
查看英文原文
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.
Theanticipated 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.
Originally posted on Himalayas