Director, Clinical Development

Description de l'emploi

Specific Responsibilities:

Essential Functions:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. We strive to transform and simplify care for people with life-threatening illnesses around the world. Gilead's portfolio of products and pipeline of investigational drugs includes treatments for viral disease, inflammatory disease, and cancer.

Specific Job Requirements

Reporting to the Oncology Therapeutic Area Lead of Clinical Development Japan, the person in this position plays an integral role in the scientific planning, execution and reporting of clinical studies in Japan for Gilead’s development compounds. Although generally assigned to a specific therapeutic area, the person in this position may support local clinical research activities across development programs. The key activities include the following:

• Clinical Study
  • Collaborate with Clinical Development in the US Headquarters to develop and/or review study designs and protocol synopses.
  • Author and/or review the clinical sections of study materials, CTN and briefing document for PMDA meeting.
  • Responsible for scientific matters in clinical trials and respond to questions from Japanese investigators.
  • Perform and/or support medical monitor activities for clinical trials conducted in Japan.
• Key Opinion Leader (KOL) Engagement
  • Identify KOLs in the assigned development area and foster long-term science-based partnerships.
  • Ensure the participation of Japanese KOLs in the Steering Committee in each study.
  • Update clinical trial data and development pipeline to Japanese physicians.
• JNDA
  • Author and review clinical sections of regulatory documents including filing dossiers, responses to inquiries, and JPI revisions.
• Publication
  • Author or review abstracts, slides, posters, and articles of the study results, especially Japanese sub-analysis with the cooperation of the US Headquarters and the presenters/authors.
• Research Collaboration & Business Development
  • Liaise with the US Headquarters for research collaboration proposals from Japanese researchers and support the discussion.
  • In business development, participate in due diligence and provide scientific assessment.

• When assigned as a Project Lead, leads the following project tasks:
  • Author the Clinical Development Plan with project members.
  • Collaborates with project members to accelerate development and approval of assigned compounds and additional indications in close communication with Global Development Team members.
  • Track the progress and problems of development projects in Japan, and work with team members to solve problems.

Knowledge, Experience & Skills:

Essential:

Desirable:

Specific Education and Experience Requirements

• Advanced degree (i.e. MD, PharmD/Pharm.M, PhD) preferred and with industry experience.
• Thinking and application ability of clinical development to formulate the optimal and expeditious development strategy in Japan with mindset to think globally and to act locally.
• Communication skills including in English to collaborate with the relevant functions in the US Headquarters and the Japanese affiliate toward common goals and to share information in a timely manner.
• Skills for negotiation with regulatory authorities and investigators to facilitate clinical trials and JNDA reviews.
• Leadership and desirably project management skills to lead clinical development of new drugs.
• Logical thinking and problem-solving skills to analyze the root cause of the problem and develop and implement countermeasures.
• Scientific thinking and Medical Writing skills capable of authoring clinical study protocols, clinical sections of JNDA dossier and scientific manuscripts.
• Skills for comprehension and presentation of scientific data
• Knowledge of statistical analysis to understand the statistical data.
• Knowledge of clinical guidelines and related regulations in Japan, the US, and Europe.

Cutting edge expertise in assigned therapeutic area.