Oncology Clinical Development Assoc. Director (M.D.) at Morunda K.K. | JP | Rezi

Oncology Clinical Development Assoc. Director (M.D.) at Morunda K.K.

Oncology Clinical Development Assoc. Director (M.D.)

Morunda K.K. · JP

3 weeks ago

Oncology Clinical Development Assoc. Director (M.D.)

Morunda K.K. · JP

a month ago
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About the Role

Lead early- and late-stage clinical development programs across multiple oncology assets, providing medical leadership and scientific expertise. Collaborate with cross-functional teams, manage clinical trials, and partner with global development teams to bring transformative treatments to patients worldwide.

Responsibilities

  • Provide medical leadership and scientific expertise for oncology clinical development projects.
  • Lead early- and late-stage development programs from a medical perspective.
  • Collaborate with cross-functional internal teams, CROs, investigators, and Key Opinion Leaders (KOLs).
  • Manage the progress of clinical trials and ensure high-quality medical oversight.
  • Partner closely with global development teams and international counterparts.
  • Work with Regulatory Affairs to support interactions with health authorities.
  • Develop and execute publication strategies and scientific communication activities.
  • Provide medical expertise as a core member of oncology development teams.
  • Review clinical trial protocols, regulatory submissions, and other development documents.
  • Provide medical guidance on immune-related adverse events (irAEs), adverse events (AEs), and serious adverse events (SAEs), including communication with internal and external stakeholders.
  • Deliver scientific and medical education to internal teams through presentations and training.
  • Lead strategic planning for early- and late-stage oncology development programs.
  • Develop clinical development strategies and key study documents.
  • Coordinate with internal stakeholders, CROs, and external experts to ensure successful study execution.
  • Collaborate closely with global project teams throughout the development lifecycle.
  • Support interactions with regulatory authorities.
  • Plan and manage domestic advisory board meetings.
  • Support global advisory activities, including collaboration with leading researchers and healthcare professionals.
  • Prepare and review documents for regulatory submissions.
  • Participate in regulatory meetings and respond to health authority inquiries as the clinical representative.
  • Develop publication strategies and oversee publication activities.
  • Author or contribute to scientific manuscripts, review articles, and other publications.
  • Attend domestic and international scientific congresses to gather and share medical insights.
  • Support scientific exchange between healthcare professionals and global medical teams.

Requirements

  • Medical Doctor (MD) license required.
  • Minimum 5 years of clinical practice experience in Japan, including oncology.
  • Experience in pharmaceutical-sponsored clinical trials, academic clinical research, or investigator-initiated studies (3+ years preferred).
  • Native-level Japanese.
  • Business-level English with the ability to participate in scientific discussions, medical meetings, and daily collaboration with global teams. Strong conversational English is essential.

Skills

  • Oncology clinical development
  • Medical leadership
  • Scientific expertise
  • Clinical trial management
  • Regulatory affairs
  • Publication strategy
  • Scientific communication
  • Cross-functional collaboration
  • Global development teams
  • Key Opinion Leaders (KOLs)

Location

  • Japan

Work Type

  • Full-time

Experience Level

  • 5+ years clinical practice experience in Japan
  • 3+ years experience in clinical trials

Education Level

  • Medical Doctor (MD) license
  • PhD in Medicine, Pharmacy, Nursing, or Life Sciences is preferred

Benefits

  • Lead innovative oncology clinical development across early- and late-stage programs with a strong global pipeline.
  • Work closely with global teams, KOLs, and regulatory authorities, gaining significant international exposure and influence.
  • Join a collaborative network of experienced physician leaders in Japan and globally, with strong mentorship and knowledge sharing.
  • Enjoy diverse long-term career opportunities across clinical development, medical affairs, and global leadership roles.
  • Make a meaningful impact by helping bring cutting-edge cancer therapies to patients worldwide.

About the Company

  • Leading global research-driven biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines.
  • Strong presence in oncology and one of the industry's most robust clinical development pipelines.
  • Invests heavily in cutting-edge science and global collaboration to bring transformative treatments to patients worldwide.
  • Offers extensive opportunities to work with international teams, renowned medical experts, and key opinion leaders while contributing to both early- and late-stage clinical development programs.