Job Description
Job Duties
We are looking for a Japan Clinical Director to serve as a key figure in early and late-stage development projects for multiple products in the oncology therapeutic area.
Responsibilities include project leadership for early and late-stage development, internal and external negotiations for clinical trial implementation (negotiations with internal departments, CROs, and KOLs), progress management, collaboration with global team counterparts, coordination with regulatory affairs departments for interactions with regulatory authorities, and publication activities.
We plan to assign appropriate tasks based on the candidate's interests and previous experience through the interview process.
Project Leadership for Early and Late-Stage Oncology Development
Strategic development planning, protocol design, management of clinical study report preparation, internal and external negotiations for clinical trial implementation (negotiations with internal departments, CROs, and KOLs), progress management, collaboration with global team counterparts, and interaction with regulatory authorities.
Advisory Board Related Duties
- Planning and operation of advisory board meetings related to domestic development, etc.
- Advisory board meeting-related tasks associated with global R&D (recommendation and support of researchers, etc.)
Regulatory Authority Interaction
Preparation of documents for submission to authorities, preparation and review of responses to inquiries, and attendance and discussion at regulatory consultations as the clinical representative.
Publication Related Duties
- Creation of publication plans and process management for publications.
- Writing of review articles and other papers related to products.
- Scientific and medical information gathering activities at domestic and international academic conferences.
- Support and management of scientific and medical engagement activities between physicians/medical professionals and the global headquarters.
Qualifications
<Education>- Master's degree in a science field (Required), Pharmacist license (Preferred)
- PhD in medicine, pharmacy, nursing, or natural sciences (Preferred)
- Native-level Japanese (Required)
- Business-level English: Ability to conduct scientific, medical, and general business discussions and daily operations smoothly with global department personnel (Required). Specifically, must possess business-level conversational ability.
<Experience, Knowledge, Skills, and Abilities>
- Experience in clinical development and regulatory submission as an Oncology project leader at a pharmaceutical company (Required).
- Disease knowledge in the Oncology field (Required).
- High ethical standards and the ability to make balanced compliance judgments based on a solid understanding and knowledge of relevant laws, regulations, guidelines, and guidance.
- Strategic and logical thinking skills, as well as the ability to demonstrate solid practical skills in both science and operations.
- Experience working in cross-functional and cross-border organizations and work environments.
- Possess a network of domestic physicians, researchers, and medical professionals in the oncology field and be able to exert excellent influence externally.
- Established interpersonal communication and presentation skills necessary for close collaboration with internal (domestic/international) departments and external specialists.
- Ability to travel domestically and internationally (academic conferences, clinical trial/research facilities, etc.).
- Ability to act proactively and work efficiently and effectively to achieve results in a constantly changing and challenging environment.
*This is a manager-level position.
Required Skills:
Biomarker Assay Development, Clinical Research, Clinical Site Management, Clinical Study Design, Clinical Trials Operations, Detail-Oriented, Ethical Compliance, Ethical Standards, Good Clinical Practice (GCP), Medical Writing, Multiple Therapeutic Areas, Patient Recruitment, Scientific Writing, Strategic Thinking, Veterinary Research
Preferred Skills:
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:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
03/31/2027
***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.