Clinical Development Lead

Clinical Development Lead (CDL) is responsible for the overall Japan clinical development plan for assigned projects. CDL ensures studies are designed to fit Japan specific requirement and situation from clinical, regulatory, and operational perspectives. CDL is accountable for planning and execution of assigned clinical studies and leads communication with the external stakeholders (e.g. investigators, regulators, KMEs, academic societies). CDL is accountable for clinical contents of local study documents (e.g. protocols, IBs, ICFs) and regulatory documents (e.g. briefing books, responses to regulatory queries, CTDs).

• Develops Integrated Development Plan (IDP): accountable for Japan clinical development strategies
  • Provides RDPT with necessary information including disease landscape, SOC, KMEs and competitor situation in Japan
  • Works collaboratively with the Project Team and PDC members to integrate the scientific rationale, regulatory requirements, operational feasibility, product development plan, and commercial goals to build a solid strategic framework for the Japanese components of the IDP
  • Leads clinical development strategy discussion.
  • Ensure that a Japanese strategic plan is fully aligned with a global strategy and is fully understood by a project team
• Leads clinical studies in assigned projects as an owner of the studies.
  • Ensures the study protocol is applicable to Japanese medical practice and manages local protocol amendment, if necessary.
  • Ensures that the resources and budget necessary for the successful execution of the trial are secured in collaboration with the CTM.
  • Accountable for study feasibility in Japan
  • Accountable for CRO and vendor selection and study budget.
  • Proactively identifies study level risks and drives execution of risk mitigation strategies
  • Accountable for solving study related issues in Japan including management of AEs in collaboration with Study Medical Director and Safety Physician.
  • Maintains study quality
  • Understands the protocols and educate study team members
• Leads medical and scientific discussion as a Biogen Japan clinical representative with investigators and KMEs.
• Serves as a local clinical representative in regulatory interactions in Japan

• Prepares and/or reviews clinical contents of regulatory submission documents and responses to clinical regulatory inquiries.
• Participates in regulatory consultations and discussions

• Science background and education (Bachelor's Degree or equivalent), MD/PhD/PharmD preferred
• Strong clinical credentials and/or drug development experiences in the therapeutic areas combined with strong grounding in scientific research.
• Clinical development experience within in biopharmaceutical industry (at least 3 years in product development).
• Experience working with regulatory agencies (PMDA experience preferred)
• Ability to lead scientific discussion on mechanisms of new research approaches, clinical endpoints, protocol design, and data interpretation
• Established or has ability to establish peer level relationships with therapeutic area opinion leaders worldwide
• Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment
• Demonstrated strategic and critical thinking
• Excellent communication skills (oral and written) with business level English and excellent organizational skills
• Ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills