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 Japan Medical Strategy Lead of Treprostinil Palmitil Inhalation Powder (TPIP) programs shall demonstrate excellence in medical science, strategy and operations. As a key contributor and collaborator, the Director shall also demonstrate cross-functional leadership for the planning / execution of strategies / tactics of TPIP and its therapeutic-area / indications consistent and cohesive to the overall corporate / GK objectives, Brand Plan and Japan Medical Affairs Plan (JMAP) throughout the life cycle of TPIP. The Director works in close collaboration and partnership with various internal business partners 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, change management, and deep knowledge / experience of modern Medical Affairs remit as well as the pharmaceutical industry's clinical and regulatory landscape.

Roles and Responsibilities:

• Excellence in strategy: Partner with Medical Affairs Leadership Team (MALT), TPIP Medical Affairs Team (TMAT), global / local internal business partners and external stakeholders to plan and execute GK Brand Plan, strategies / tactics in JMAP of TPIP and its indications.
• Excellence in medical science: The Director shall gain and provide valued-added information and insights to internal and external stakeholders with in-depth and up-to-date understanding of TPIP, its indications / therapeutic area and technologies to ensure high quality of science in all aspects of MA duties.
• 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.
• 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.
• Competitive Intelligence (CI): Conduct CI to provide quality inputs and insights to the planning, execution and update of JMAP.
• 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., TPIP Medical Affairs Team (TMAT), Insmed Medical Affairs Research Review Committee (IMARRC), Integrated Evidence Team (IET) meeting).
• 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.
• 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.
• Company Business: Partner with internal functions and external stakeholders to lead and support local business in Japan.
• People Management: When assigned, manage JMA staffs and teams/functions.

Required experience and knowledge:

• 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.
• Solid experience in managing cross-functional team consisting of both medical/scientific experts (senior level) and operational/administrative professionals.
• The followings 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.
• 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.
• 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.

Required skills and capabilities:

• Language: Native-level fluency in Japanese and high-level business fluency in English (very important).
• 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.
• 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.
• 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 while 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.
• People: Works productively across local and global organizations as a team player. Ability to influence without authority.

Qualification:

• Must live in the greater Tokyo area so that be able to commute to/from GK office as necessary.
• Must be able to travel in Japan and overseas (e.g., including domestic and international congresses and US HQ).
• Degree, License:
  • Master’s degree in pharmacology, pharmaceutical, clinical and life science or equivalent field of study is highly preferred.
  • A candidate with the 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.
  • A candidate with the Bachelor’s degree will be considered if the candidate has significant MA experience.
  • Health care providers are highly encouraged to apply.
  • Experience in clinical development is advantageous.

Others:

• Must possess and successfully exhibit Insmed five (5) core corporate competencies of Collaboration, Accountability, Passion, Respect and Integrity (CAPRI) along with any other position specific competencies.
• Take leadership to realize Mission, Vision and Value Proposition of Japan Medical Affairs.
• Individuals must demonstrate the ability to interact successfully in a fast-paced, dynamic and culturally diverse workplace locally and globally.
• Non-smoker (must).
• Must have an ability to travel (domestic and international) approximately 10% - 30% of time.

At Insmed, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

 

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus 
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

 

For more information on U.S. benefits click here.

Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.

 

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 TotalRewards@insmed.com 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.

 

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.

 

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