Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

 

	Consistently Ranked Science’s Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

 

The Associate Director 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.

Responsibilities (Essential Role Responsibilities): 

• 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:

1.    Propose CSSs for Global Reviews and Approvals

• Develop study concepts aimed at addressing identified UMNs and assess feasibility as necessary.
• Submit study concepts to the Integrated Evidence Team (IET) meetings, present the study background and outlines, and obtain team endorsement.
• Develop the study protocols and secure approvals from HEOR Protocol Review Committee (HPRC).

2.    Execute the CSSs

• Develop and/or review CRFs, ICs, SAPs, TFLs or analyses outcomes and CSRs.
• Select and oversee/manage CROs/ venders, ensuring appropriate engagement in activities, contracts, and payment.
• Train and interact effectively with cross-functional study teams and study sites.
• Organize and collaborate with the steering committee.
• Manage study timelines and budgets, and update Global study database (SmartSheet) accordingly.
• 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.

Position Requirements (Required and/or Preferred Skills, Experience and Education): 

• 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 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.

​<Essential Requirements>

• Database studies using commercial databases (e.g., JMDC, MDV, etc.): 5 or more
• PRO studies: 2 or more
• Studies using pre-existing datasets (e.g., clinical trials, PMS, chart reviews): 5 or more
• Company sponsored-prospective study (regardless of interventional or observational): 2 or more

<Highly Preferred Experience> 

• Systematic review and meta-analysis (or experience in literature gap analysis): 3 or more
• CEA: 1 or more
• Expert consensus development using the Delphi method: 1 or more
• Validation of QOL measures: 1 or more
• Development of algorithms for disease diagnosis/progression using AI: 1 or more

• 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.
• Must demonstrate Insmed’s five core corporate competencies: Collaboration, Accountability, Passion, Respect and Integrity
• Strong interpersonal skills and the ability to succeed in a dynamic and culturally diverse workplaceNon-smoker

Travel:

• Up to 30% travel for congresses in Japan and overseas, meetings with external stakeholders and venders, and meetings in offices of Insmed, Inc. 

The Company will participate in Worker’s Compensation Insurance, Unemployment Insurance, Health Insurance and Welfare Pension Insurance. Other benefits and the details will be communicated separately.

This position is based at the Tokyo Office.