Associate Director, Clinical Development

Associate Director, Clinical Development Japan

Overview
Alnylam Pharmaceuticals is seeking an imaginative drug developer, with the flexibility and
confidence to work in the Clinical Development Japan. This role involves leading multiple projects
and contributing to the clinical development of RNAi therapeutics in Alnylam’s expanding portfolio,
which includes both rare genetic diseases and prevalent diseases.
The Associate Director of Clinical Development Japan (CDJ-AD) will be responsible for collaborating
with relevant colleagues across Alnylam and with our partners to inform target and indication
selection, and to shape and execute clinical-regulatory strategies to efficiently advance these
molecules into and through clinical development in Japan. In this role, he/she will interface
extensively with external experts in Japan, obtain feedback on clinical development plans and stay
abreast of new developments in the field. Based on obtained information, he/she will cross
functionally collaborate and develop the efficient and effective Japan Clinical Development
strategy to be incorporated into the Global Development strategy. As molecules advance into the
clinic, he/she will work with clinical development colleagues to oversee the design and timely
progression of associated clinical trials in Japan.
The ideal candidate that we seek will be a highly innovative, collaborative, scientifically grounded
and expert drug developer with a flexible, hands-on and team-oriented style. The CDJ-AD will lead
the discussion of clinical development Japan, and be a partner & influencer to counterparts in all
relevant Japan/Global functions, such as Research, Early Development, Regulatory, Clinical
Operations, Data Sciences & Statistics, Safety and other expertise areas.
He/she will serve as the primary representative of Alnylam Japan Drug Development in external
meetings including discussions with Japanese regulatory authorities and advisory boards for
specific therapeutic areas.
This position is hybrid onsite and remote working and will be primarily located at Tokyo.

Key Responsibilities
• Project Leadership: Lead multiple projects and develop creative but realistic approaches to Japan drug
development.
• Strategic Collaboration: Collaborate closely with relevant functions in Japan and Global Development
(e.g., Preclinical, Regulatory Affairs, and Medical Affairs) to develop Japan clinical development plan and
ensure tight strategic integration into global development plans.
• CDST member: Responsible for the J-Clinical Development Plan and is a member of the Clinical
Development Sub-Team (CDST).
• Disease area strategy：Creating strategic plan for specific disease area.
• Clinical Trial Oversight: Oversee the design and timely progression of clinical trials in Japan, ensuring
their conduct and safety.
• CRO management and risk management: Serve as the local face of Clinical operation for CROs to ensure
that clinical trials are conducted appropriately and according to the timeline. Report any critical issues at
the CRO or ICCC to the relevant global departments in a timely manner.
• Local CDMA role： support CRA in site initiation and patient recruitment by providing clinical expertise in
protocol and disease knowledge.
• Documentation and Review: Review all major written clinical deliverables (clinical part of regulatory
submissions, Clinical trial relevant documents) and presentation materials produced or used in Japan.
• Support the Director: Assist the Director in providing a strong, clear voice for the Japan clinical program
and operation.
• Process improvement: Contribute to process optimization efforts or initiatives impacting CDJ.
• Team Support and Development: Support Senior Managers and Managers under his/her team,
contributing to their development and the overall growth of the development team in Japan.
• KOL development: Develop collaborative relationships with KOLs in key disease area to ensure the
success of clinical development in Japan
• Regulatory Interactions: Represent Alnylam Japan Development in external meetings, including
Japanese regulatory interactions and scientific meetings on the assigned therapeutic areas/ projects.

Qualifications
• Education: Advanced degree in life sciences/healthcare (MD, PhD, or Pharmacy Master or higher
preferred).
• Experience: Minimum 10 years in drug development, including leading clinical development programs in
Japan, actively interacting with KOLs, conducting PMDA consultation and playing a clinical role in
submitting a new drug application.
• People Management: Experience in managing people in clinical development is preferable.
• Partnership Experience: Experience and knowledge of working with biotech/pharma partners and CROs.
• Drug development knowledge: Understanding of regulations, ICH guidelines, drug development, clinical
trial design and process, biostatistics, compliance with GCP and strategic planning.
• Leadership and Collaboration: Adaptable and able to effectively lead, collaborate, and influence across a
complex matrix organization.
• Ambiguity Management: Demonstrated leadership in ambiguous situations; able to inspire a team to
excel by fostering a climate of energy, excitement, and personal accountability.
• Communication Skills: Excellent written and verbal communication skills. English skill in Business.
• Entrepreneurial Spirit: Thrives in a highly entrepreneurial biotech environment and embraces Alnylam’s
culture of science, passion, and urgency.

About Alnylam
Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality,
with a robust RNA interference (RNAi) therapeutics platform. As the pioneer in RNAi and the
leading RNAi therapeutics company, we have always been uncompromisingly dedicated to
translating the breakthrough science into transformational medicines to help as many people as possible. Long focused on rare and genetic diseases, our scientific advances are now allowing us to bring the power of RNAi therapeutics to more prevalent diseases and as a result, we are beginning to recognize the full potential of this new class of medicines. You can learn more about our pipeline
here.
Alnylam is committed to its journey to become a top 5 independent, global biopharma company. We are already admired and recognized for our dedication to patients, company culture that empowers people to do their best work, track record of scientific innovation, social responsibility, and commercial excellence.
Alnylam Pharmaceuticals is a global leader in RNA interference (RNAi) therapeutics, founded in 2002 and headquartered in Cambridge, Massachusetts. As of August 2025, the company employs over 2,230 professionals worldwide, reflecting its continued growth and commitment to innovation.
Alnylam is dedicated to transforming the lives of patients with rare and common diseases through RNAi-based medicines. We seek smart, passionate individuals who are ready to say “challenge accepted” to our mission.
Thanks to the dedication of our global workforce, Alnylam has been consistently recognized for its workplace excellence and innovation, including:
• Fast Company’s Best Workplaces for Innovators (2021–2024)
• Science Magazine Top Employer (2019–2024)
• Boston Globe Top Places to Work (2015–2024)
• Great Place to Work certifications in Asia, Brazil, the U.K., and Switzerland
• Searmount’s 100 Best Companies and Best Companies for Dads
• Inclusion in Bloomberg’s Gender Equality Index
In 2025, Alnylam achieved key milestones such as expanding its TTR franchise and launching new Phase 3 trials for ATTR-CM and hypertension therapies.
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.