Job Details
This role will effectively lead clinical assets through successful development of early and late phase clinical development strategies and deliverables in partnership with multiple functions across the organization, and with external academicians and collaboration partners. Provide direction and leadership for the clinical development pipeline programs in drug development and is responsible for the strategy, direction and execution of the company's clinical development plans.
Key Roles & Responsibilities
- Responsible for clinical development strategies, including Phase I through III in oncology, life cycle management, safety responsibilities, scientific interactions with regulatory authorities, internal cross functions and external partners.
- Leads and oversees the strategic definition and tactical development of clinical trials programs, including protocol, interpretation of clinical data, and literature reviews.
- Accountable for the delivery of projects according to quality, time, budgets, and resources
- Ensures that clinical trials are conducted in accordance with applicable regulatory requirements and guidelines.
- Play a lead role in the development and implementation of communications strategies to support existing and completed studies including KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials.
- Contribute clinical science input into the relevant therapeutic/disease area scientific strategy.
- Identify strategic and incremental organizational resource needs re: People, Process and Technology.
- Plan and direct career development for China & US oncology team members.
Role Requirements
- MD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
- Experience in pharmaceutical or biotech industry working with Phase I – III clinical trials, experience in Oncology clinical development strategies, clinical trial design and protocol development.
- More than 10 years' experience of broad bio/pharmaceutical industry experience in drug development.
- Experience in a related therapeutic specialty such as oncology, immunology other related specialty.
- Pharmaceutical industry experience in the successful development, registration and commercialization of new drug products is preferred.
- Independent, self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive management style.
- Excellent organizational communication and coordination skills.
- Good interpersonal and ownership.
- Hybrid Working.