Total 3 Director/C-Level Science / R&D / Research job vacancies in Tokyo - Japan

About the role:

As a senior member of Morningstar’s Manager Research team in Japan, the Associate Director plays a leading role in Morningstar’s manager research operation in Japan, delivering high quality and timely research to investors and clients. In addition to conducting fund due diligence and writing research reports, the Associate Director is charged with promoting Morningstar’s mission and research capabilities through our global thought leadership program, along with active engagements with the external market on key investment and industry issues that are relevant to Japanese investors. The role is based in our Tokyo office.

Job responsibilities:

• Take the lead in producing high quality and timely manager research reports; assist analysts in formulating and defending our opinions on investment strategies through report editing and in rating committees; contribute to the link up with global analyst teams.

• Enhance Morningstar’s research profile in Japan through active engagements with the external market (wealth managers, media, regulators, and clients) in areas including (but not limited to) industry trends and development, policy and other investment issues that are relevant to Japanese investors.

• Strengthen perceptions of Morningstar’s research capabilities in Japan through contributions to the international thought leadership program and production of local research content.

• Support ongoing client deliverables of Morningstar’s investment advisory offerings in Japan. Help drive and develop scalable ways of delivering better services to Morningstar’s client segments.

• Actively promote Morningstar’s investment advisory capabilities when interacting with Morningstar’s target audience and prospects.

• Handle ad-hoc client enquiries and undertake administrative and/or analytical work as required.

Qualifications:

• Bachelor’s degree, preferably in finance or business-related discipline; Chartered Financial Analyst® designation and/or MBA is desirable.

• At least 7-10 years of investment-related experience, working in a manager research and/or portfolio management role. Understanding of Japan-based investment managers would be viewed favourably.

• A keen knowledge of financial markets that has been developed both personally and professionally;

• Strong written and verbal English and Japanese communication skills, with a demonstrable track record in writing succinct analysis.

• Solid presentation skills; experience with the media, clients, and large audiences is preferred.

• Strong quantitative skills with good grasp of statistics.

• Ability to demonstrate initiative, work independently and prioritise effectively to meet deadlines.

• Independent, experienced researcher who is passionate and familiar with modern finance and investment theory. Portfolio construction and asset allocation experience will be viewed favourably

• Demonstrable interest in industry trends and development, along with regulation and policies that are relevant to Japanese investors.

• Aptitude to build effective relationships with key stakeholders and a demonstrable ability to influence internal stakeholders to build consensus amid competing priorities.

• Skilled with PC and mainstream software packages. Experience with Morningstar Direct is an advantage.

Morningstar is an equal opportunity employer.

Morningstar’s hybrid work environment gives you the opportunity to work remotely and collaborate in-person each week. We’ve found that we’re at our best when we’re purposely together on a regular basis, at least three days each week. A range of other benefits are also available to enhance flexibility as needs change. No matter where you are, you’ll have tools and resources to engage meaningfully with your global colleagues.

Job Description

クリニカルリサーチ領域（オンコロジー以外の領域：ジェネラルメディスン・感染症・ワクチン）での以下の業務を担当：

＜医学専門家として＞

・ 開発チームの一員として、開発案件に対する医学専門家としてのアドバイス、文書（治験実施計画書や申請資料等）の医学的レビューを行う

＜日本の開発プロジェクト責任者として＞

・米国本社と連携して、本邦での臨床開発計画の立案・作成、 臨床試験の実施、製造承認の取得

・日本のサイエンティフィックリーダーとのscientific exchange、関係構築

・本邦で実施する治験の医学的／科学的側面からリード

・治験に関する学会発表及び／又は論文作成、あるいはそれらのサポート

職務経験

・医師免許をお持ちの方

・5年以上の医療現場での臨床経験（必須）

・チーム間の協力を促進する能力

・英語での交渉力、スピーキング、ライティング力

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna is expanding its presence in Tokyo, a city known for its blend of tradition and innovation. Our new commercial office here will focus on bringing our advanced mRNA products to the Japanese market. Nestled in the heart of Tokyo's vibrant landscape, we're looking to integrate into the local biotech scene while contributing our global expertise. We welcome professionals who are passionate about making a difference in healthcare to join our team. Here you'll be part of a community dedicated to simple yet profound goals: enhancing health outcomes and providing cutting-edge treatments in Japan. Join us in Tokyo where your efforts will help shape the future of medicine in an environment that values both tradition and innovation.

The Associate Director, Regulatory CMC, will be an integral part of Moderna’s team in Tokyo, focusing on developing and executing Japan Regulatory CMC strategies for both R&D and marketed products. This position plays a crucial role in aligning local regulatory strategies with global project goals, ensuring compliance with Japanese regulatory requirements. The role demands proactive engagement in Regulatory CMC discussions, effective risk management, and collaboration with health authorities. Additionally, the role involves guiding manufacturing and quality teams in regulatory compliance and post-market regulatory activities.

Here’s What You’ll Do:

Within 3 Months, You Will…

• Develop a deep understanding of the landscape of mRNA therapeutics in the Oncology field, which is crucial for strategic planning in regulatory affairs.

• Start actively contributing to regulatory submissions, including National Scientific Advice (NSA) meeting requests and clinical trial applications. This involves preparing necessary documentation and coordinating with teams to ensure submissions are comprehensive and compliant.

• Begin engaging with project teams and committees to align on regulatory strategies, ensuring that regulatory plans are integrated with the broader objectives of the oncology programs.

Within 6 Months, You Will…

• Take the lead in coordinating and managing regulatory submissions and amendments in EU and International markets. This includes overseeing the submission process and ensuring that all regulatory requirements are met.

• Develop a comprehensive understanding of EU and International regulatory requirements, which is essential for successful regulatory strategy development and implementation.

• Build and maintain effective communication with regulatory agencies relevant to assigned projects, ensuring that Moderna’s submissions and responses are timely and meet the expectations of regulatory bodies.

Within 12 Months, You Will…

• Be fully integrated into the Regulatory Strategy team, driving major submissions and regulatory interactions. This means taking a leadership role in the preparation and submission of important regulatory documents.

• Independently manage multiple projects, effectively balancing regulatory risks and strategic goals. This involves decision-making and strategy development for various regulatory initiatives.

• Become a key contributor to Moderna’s success in transforming patient lives through mRNA science. This entails not only successful regulatory submissions but also contributing to the strategic direction of Moderna’s oncology portfolio.

Here’s What You’ll Bring to the Table:

Minimum Qualifications

• BA/BS degree in a scientific/engineering discipline

• 10+ years of experience in the pharmaceutical/biotech industry

• 7+ years of experience in Regulatory CMC, both R&D and post-marketed field

• Strong knowledge of current Japanese regulations and regulatory trend, especially in CMC field 

• Strong knowledge of cGMP

• Strong experience with CTD format and content regulatory filings

• Strong written and oral communication in English along with Fluency in Japanese

Preferred Qualifications

• MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable

• 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus

• 5+ years of experience in Biologics and vaccine focused Regulatory CMC

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
• Educational resources
• Savings and investments
• Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

-