Description

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we’re in. Are you?<div><div><div><div><div><div><div>About the Role:</div></div></div></div></div></div></div>The Medical Strategy Lead (NTM) shall demonstrate excellence in medical science, strategy and operations. As a key contributor and collaborator, this position shall also demonstrate cross-functional leadership for the planning / execution of strategies / tactics of NTM programs (r-MAC and MAC-LD) consistent and cohesive to the overall corporate / GK objectives, Brand Plan and Japan Medical Affairs Plan (JMAP) throughout the life cycle of product. The individual in this position works in close collaboration and partnership with various internal business partners (Japan and global) and external stakeholders, including but not limited to, healthcare professionals (HCPs), medical/professional societies, government authorities and third-party vendors. This role requires a combination of program management, leadership by influence, strategic thinking, risk / change management, and deep knowledge / experience of modern Medical Affairs remit as well as the pharmaceutical industry's clinical and regulatory landscape.<div><div><div><div><div><div><div>What You'll Do:</div></div></div></div></div></div></div><ul><li>Excellence in strategy: Partner with Medical Affairs Leadership Team (MALT), Medical Affairs Team (AMAT), global / local internal business partners, including commercial partners, and external stakeholders to plan and execute GK Brand Plan, strategies / tactics defined in JMAP for product.</li><li>Excellence in medical science: This individual shall gain and provide valued-added information and insights to internal and external stakeholders with in-depth and up-to-date understanding of product, its indications / therapeutic area and technologies to ensure high quality of science in all aspects of MA duties.</li><li>Excellence in operations: In close collaboration with JMA teams and internal / external stakeholders, lead, manage and coordinate the development and implementation of JMAP. Ensure that the activities are planned and executed on-scope, on-time and on-budget in compliance with all applicable laws, regulations, policies/rules, SOPs and requirements.</li><li>Expert Engagement and Scientific Exchange: Lead, manage, coordinate and facilitate engagement between internal and external stakeholders (e.g., Scientific Leader (SL), HCP, congress, medical / academic and professional society). Ensure fully compliant, professional and balanced exchange of scientific / medical and business information and insights. Gain scientific / medical and business insights and translate them to strategy / tactics planning and implementation.</li><li>Competitive Intelligence (CI): Conduct CI to provide quality inputs and insights to the planning, execution and update of JMAP.</li><li>Governance: Lead the review and decision processes locally (e.g., Japan Medical Review Committee (J-MRC), Japan Commercial Review Committee (J-CRC), Japan Grant Review Committee (J-GRC), JMA review of Medical Information Letter) and globally (e.g., Arikayce Medical Affairs Team (AMAT), Insmed Medical Affairs Research Review Committee (IMARRC), Integrated Evidence Team (IET) meeting).</li><li>Clinical Development: Partner with clinical development functions, actively engage in clinical development strategy building, planning, including engagement with authorities such as PMDA and MHLW as well as medical review of clinical / regulatory documents (e.g., J-IND, J-NDA, J-PSUR). Support identification and selection of external medical experts. Support Clinical Trial Operations for their assessment of clinical sites and investigators as well as patient recruitment in clinical studies.</li><li>In-house Medical Expert (a candidate with the license to practice medicine in Japan): Act as an internal medical expert to provided medical guidance and expert opinion to support Insmed activities including but not limited to drug safety and pharmacovigilance as well as product quality surveillance.</li><li>Company Business: Partner with internal functions and external stakeholders to lead and support local business in Japan.</li><li>People Management: When assigned, manage JMA staffs and teams/functions.</li></ul>Who You Are:Required experience and knowledge: <ul><li>Minimum of 10 – 15 years of experience with the track record of success in Medical/Scientific Affairs in a pharmaceutical / biotechnology company in Japan in a global setting.</li><li>Solid experience in managing cross-functional team consisting of both medical/scientific experts (senior level) and operational/administrative professionals.</li><li>The following are the examples of typical MA and clinical development experience and knowledge desired for successful career in Insmed: medical education, health economics and observational research, scientific communication, publication, clinical development of late-phase product, etc.</li><li>Experience in IND and NDA in Japan, NHI pricing negotiation, product launch excellence and life cycle management of pharmaceutical products in Japan is highly desired.</li><li>Proven record of knowledge and experience in the field of pulmonary, infectious and/or cardiovascular diseases is strongly preferred. Additional experience in rare and/or neglected diseases may be a plus.</li></ul>Required skills and capabilities: <ul><li>Language: Native-level fluency in Japanese and high-level business fluency in English (very important).</li><li>Ethics and compliance: Adherence to uncompromising ethical standards. Solid understanding of applicable local and global policies, rules and regulations as well as compliance policies and requirements of the pharmaceutical industry in Japan.</li><li>Business acumen: Strong understanding of pharmaceutical business, including drug research and development, manufacturing, commercialization. Established strategic and logical thinking, and highly effective analytic skills. Highly organized with a strong attention to detail, clarity, accuracy and conciseness.</li><li>Communication/Presentation: Strong ability to quickly understand and dialogue on subjects that are at the interface between medicine and policy. Ability to connect science/medicine and unmet medical need to MA strategy. Excellent in disseminating and communicating complex scientific information and data in an impactful, balanced and user-friendly way. Excellent intra-personal and presentation skills (verbal and written, in Japanese and English) with the ability to effectively present ideas, and influence and negotiate with others to achieve desired goals.</li><li>People: Works productively across local and global organizations as a team player. Ability to influence without authority.</li></ul>Qualifications:<ul><li>Must live in the greater Tokyo area so that be able to commute to/from GK office as necessary.</li><li>Must be able to travel in Japan and overseas (e.g., including domestic and international congresses and US HQ).</li><li>Degree, License:<ul><li>Master’s degree in pharmacology, pharmaceutical, clinical and life science or equivalent field of study is highly preferred.</li><li>A candidate with a doctoral degree (e.g., Ph.D.) is preferred. Those with a degree in medicine (physician) must possess a presently active license to practice medicine in Japan. A board certification in pulmonology, cardiology and/or infectious disease is highly valued.</li><li>A candidate with a Bachelor’s degree will be considered if the candidate has significant MA experience.</li><li>Health care providers are highly encouraged to apply.</li><li>Experience in clinical development is advantageous.</li></ul></li></ul>Others:<ul><li>Must successfully exhibit Insmed core corporate value (Collaboration, Accountability, Passion, Respect and Integrity), Mission, Vision and Value Proposition of JMA along with any other position specific competencies.</li><li>Travel: Up to 30% travel based on vendor requirements</li></ul> Life at Insmed インスメッド日本オフィスは、国会議事堂を望む東京の中心部、溜池山王駅直結の好立地に位置しています。最新のワークスタイルに対応したフリーアドレス制を導入し、開放的で柔軟な働き方を実現しています。カフェエリアでは部門を超えた自由なコミュニケーションやコラボレーションを促進する空間を創り出しています。 日本法人の拠点として、患者さんにより良い医療をお届けするため、社員一同が一丸となって日々邁進しています。 社員一人一人の充実した働き方を実現するためのサポート： • ワークライフバランスの実現 フレキシブルな勤務時間や充実した休暇制度 • 魅力的な報酬制度 退職金制度、株式報酬制度、従業員持株制度（ESPP）への参加機会 • キャリア開発支援 社内研修、外部研修プログラムの活用、LinkedIn Learning、業務に特化した専門研修 • 先進的な学習支援 AI搭載の学習ツール、社内リソースへのアクセスを支援するデジタルアシスタント • グローバルの表彰制度や従業員リソースグループ活動 • ハイブリッドワーク環境の整備 場所や時差を超えたシームレスな協働を実現する最新テクノロジー、充実したIT支援体制Current Insmed Employees: Please apply via the Jobs Hub in Workday.Insmed Incorporated is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at <a target="_blank" href="mailto:TotalRewards@insmed.com">TotalRewards@insmed.com</a> and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.

Medical Strategy Lead (NTM)

Description

Insmed

Pipeline