Associate Director/Senior Manager - Value Evidence and Outcome

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?

To fulfill Japan Medical Affairs’ (J-MA's) Value Proposition of "realizing a desirable healthcare environment," the following roles are undertaken:

The Associate Director (Assoc Dir) or Sinor Manager (Sr Mgr), Value Evidence and Outcomes (VEO) plays a crucial role within the VEO/ Publication & Scientific Communication (Sci Comm) Team in Medical Affairs of Japan. The Asso Dir or Sr Mgr of VEO is responsible for planning and executing of a comprehensive Japan Evidence Generation Strategy, ensuring the development of meeting-to-unmet medical needs (UMNs), feasible, ethically compliant that align with Insmed business including strategic imperatives and Strats/Brand Plan, Health Economics & Outcomes Research (HEOR) strategies, and Japan medical strategies of Insmed portfolio.
The Asso Dir or Sr Mgr of VEO collaborates closely with various cross-functional teams within Insmed, including, but not limited to, the HEOR, Global Medical Strategy, Sci Comm & Publication Team, each function of Japan MA, Clinical Development (CD), Commercial, and Market Access & Pricing/Patient Advocacy of Insmed GK, as well as external stakeholders and venders.
This position reports to the Director, VEO/Publication & Sci Comm in Medical Affairs of Japan and is based at the Tokyo Office.

• Identify Data Gap and Resolvable Local UMNs: Identify data gap through systematic literature search and expert insights in collaboration with the Strategic Leads of J-MA, and determine resolvable local UMNs using various evidence-generation approaches, including health technology assessment (HTA). Select optimal methods or study designs, implement studies and deliver meaningful outcomes.

• Lead to Develop Japan VEO Plans: Lead the development of J-VEO/ Evidence Generation Plans to address identified resolvable UMNs, considering feasibility, budget and timing, ensuring alignment with Insmed business including strategic imperatives and Strats/ Brand Plan, HEOR strategies, and Japan medical strategies of Insmed portfolio.

​The VEO/ Evidence Generation Plans include, but not limited to, efficacy and safety assessments, epidemiology, real-world status (e.g. patient burden, effectiveness, adherence, treatment patterns, and clinical situation), costing analyses, and development of expert consensus and diagnostic/progression algorithms. Methods may include interventional and observational studies, patient-reported outcomes (PRO), pre-existing data analysis (e.g. claim/DPC database, medical chart, completed clinical study datasets) Delphi panels, and leveraging AI.

• Lead to Implement Company Sponsored Studies (CSS) activities: Lead the implementation of day-to-day activities related to CSSs. Ensure that all activities are executed in compliance with regulatory requirements (GCP), local lows (Clinical Study Act), guidelines (GLs) (Ethical GLs for Life Science/ Medical and Health Research Involving Human Subjects), company policies and SOPs, and applicable ethical standards

• Share and Update Study Information: Provide updated information and outcomes from HEOR/VEO studies or projects to Pub & Sci Comm Team for facilitate effective publications and data dissemination.

• Publication Involvement: Actively participate in publications related to responsible studies, either as an author or presenter in collaboration with Local Publication Lead. This includes taking on presenter roles for encore presentations.

• Support of HEOR-Sponsored Studies: Support HEOR-sponsored studies, e.g. assist in identifying local experts, maintaining continuous communication, discussing protocol and outcomes, and supporting study set-up. This includes obtaining approvals of study materials from J-Medical Review Committee, due diligence on local venders, and communication with Global venders to drive the studies forward.

• Provide Epidemiological Data: Support the provision of estimated epidemiological data for clinical trials, J-NDA and pricing strategies using available data sources.

• Collaboration with Market Access and Pricing Team: Work closely with the Market Access and Pricing Team to develop and execute high-quality health economic strategies. Focus on maintaining NHI price for Insmed portfolio by delivering robust evidence that demonstrates product value and drives business objectives. Prepare cost-effectiveness analysis (CEA) reports to present the value of Insmed products from an HTA perspective and respond to inquiries from the C2H and CEA Evaluation Bodies of Japanese Authorities.

• Build Effective Partnerships: Establish strong relationships with all stakeholders, including, but not limited to, external experts, the HEOR Team and Strategic and Sci Comm & Publication Teams of Global MA (GMA), CD and DSPV in both Global and Local. Collaborate with other functions within J-MA, and Market Access & Pricing/Patient Advocacy, Legal/ Compliance, and working groups.

• Information Maintenance (Data Source and Medical Venders): Actively search for, collect and maintain current and updated information regarding data sources for CSSs, such as commercial databases, academic registries and internal data (including clinical trials, PMS, market research). Additionally, track details about CROs, medical agencies, and venders, including their capabilities, standard budgets/ timelines and contract status.

• Local Publication Monitoring: Conduct a monthly search of the status of current local publications in targeted therapeutic areas and share this information with internal stakeholders to understand about the evolving medical landscape in Japan.  

Who You Are:

• Educational Requirements: A Master’s degree in a scientific discipline or equivalent experience in required elements (see below) is mandatory. An advanced degree (e.g., PhD, PharmD or MD) is highly preferred. Scientific expertise in pulmonology, bacterial infection, cardiovascular diseases and/or allergy/ immunology is highly valued. Possession of an HTA certificate is also preferred.

For MD holders, must possess a presently active medical license for the practice of medicine in Japan (foreign license holder will NOT be considered). A board certification in pulmonology, bacterial infection, cardiology and/or allergy/ immunology is highly valued.

• Professional Experience: Minimum 10 years’ relevant experience in the pharmaceutical/biotech industries within a Global setting, specifically in Japan, with a solid understanding of the pharmaceutical business, including drug research, development, manufacturing and commercialization. At least 5 years’ experience in evidence generation, with expertise across all aspects of evidence generation strategy, planning, and execution during all phases of drug development, particularly, in the post-launch/ marketed product phase. Alternatively, equivalent experience in academia or other health care delivery setting (e.g. health economics consulting company) may also be considered.

• Key Competencies: Broad experience and reliable understanding in variety of evidence generating approaches and methods.

Solid experience in playing critical roles in planning (e.g., development of study outline, protocols and SAPs) and managing operations (e.g., vendor selection/ management, feasibility assessment, expert consultations, and managing budgets and timelines) for clinical research.

For the Sr Mgr role, if certain "Responsibilities" are not fully met, their other competencies, such as assisting the Team Leaders and demonstrating biostatistical knowledge, will be considered to assess whether they can effectively fulfill the VEO responsibilities without any issues.

<Essential Requirements>

• Company sponsored-GCP study: 2 or more

• PMS study: at least 1 study

• PRO studies: 2 or more

• Studies using pre-existing datasets (e.g., clinical trials, PMS, chart reviews): 5 or more

 <Highly Preferred Experience>

• Systematic review and meta-analysis (or experience in literature gap analysis): 3 or more

• HTA-related research:At least 1 study

• oExpertconsensusdevelopmentusingthe Delphimethod:1or more

• Databasestudiesusingcommercialdatabases(e.g.,JMDC,MDV,etc.) :At least 3 studies

• Developmentof algorithmsfordiseasediagnosis/progressionusingAI:1ormore

• HTA and CEA Knowledge: Understanding of the HTA system and processes in Japan, including the CEA GLs by MHLW. Experience implementing CEA and familiarity with analysis software like ‘TreeAge’ is valued.

• Compliance and Ethical Standards: Adherence to uncompromising ethical standards, including but not limited to, applicable local and global policies, regulations, laws and guidelines such as: GCP, Clinical Study Act, Ethical GLs for life science/ medical and health research involving human subjects, GLs of International Committee of Medical Journal Editors (ICMJE)/Good Publication Practice 4 (GPP4), company policy and SOPs as well as compliance policies and requirements, Japan Pharmaceutical of Manufacturers Association (JPMA) GLs, and Guidelines for Provision of Sales Information on Prescription Drugs.

• Language and Communication Skills: Native-level fluency in Japanese and high-level business fluency in English is a must. Excellent written and verbal communication and presentation skills, with the ability to effectively convey complex scientific and clinical data to both internal and external stakeholders (e.g., scientific congresses, meetings with Global teams).

• Key attributes for success: Leadership and analytical skills with the ability to work autonomously and within cross-functional teams. Effective management of multiple workstreams while maintaining the ability to prioritize tasks.

Where You’ll Work

This role is based out of our Tokyo office with weekly flexibility to support both your professional and personal needs.

Travel Requirements

This role requires occasional domestic/global travel up to 30%

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

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Applications are accepted for 5 calendar days from the date posted or until the position is filled.