開発リード/ Development Lead

A global pharmaceutical group is looking for a Development Lead. The selected candidate will provide medical and clinical leadership across product development, clinical trials, regulatory strategy and Japan portfolio planning.

Responsibilities:

• Support local development strategies in alignment with global plans
• Provide medical and clinical input into development activities
• Collaborate with cross functional teams on development and regulatory initiatives
• Oversee clinical development activities and support trial execution
• Support local clinical study activities and stakeholder engagement
• Lead local product strategy and evidence generation planning
• Identify local data needs and translate them into development priorities
• Foster effective collaboration and support team development
• Coach and support team members where applicable
• Share project knowledge and contribute to continuous improvement

Requirements:

• Medical degree, PhD, or Master’s degree in a relevant field, or equivalent combination of education and experience
• More than 5 years of experience in clinical development experience in the biopharmaceutical industry
• Experience with clinical project lead or proven industry collaboration in academia
• Prior experience in leading clinical development and NDA filing
• Proven experience with clinical study management and conduct
• Background in conceptualising, designing, and conducting complex, global clinical trials
• Knowledge of Japanese regulatory agency organisation, guidelines, and practices and ability to negotiate with these groups
• Familiarity with new drug product lifecycle and commercialisation process
• Understanding of clinical operations, commercial, regulatory, and medical affairs, value access and policy
• Prior medical knowledge in the relevant therapeutic area
• Proven GCP, PMDA regulations, guidelines and compliance knowledge
• Fluent level written and verbal English; business level written and verbal Japanese

Preferred requirements:

• Experience managing product life cycle management in collaboration across functions as a lead and/or representative from clinical development
• Prior experience to manage early phase of clinical trial
• Proven NDA filing experience

About the Company:

A global pharmaceutical group, this organisation is an internationally recognised name in biotechnology. Responsible for a range of medicines aimed at treating human illnesses, this company supplies medical professionals and patients across the world.

Keywords:

製薬、医薬品、臨床開発、医薬品開発、ヘルスケア、医療、開発戦略、臨床試験、メディカル, 求人, 外資系

Job Ref: PW8QZX