CMO - Global Clinical Development - COVID-19 (Global Search)
Global Clinical Development Program Head
Innovative fusion protein drug development platform
About Our Client
The company is China headquartered but globally focused pharmaceutical company managing Clinical and Pre Clinical assets in Immuno-Oncology, Auto Immune and Vaccine area. Currently they are employing around 200 FTE in China and Australia across R&D, Biomanufacturing, Clinical, Medical and Manufacturing.
As a Head of Global Clinical Development program you focus will include the below:
- Provides scientific and technical leadership for Clinical Development and Pharmacovigilance of across the company portfolio with focus on COVID-19 vaccines development program
- Oversee Clinical functional activities and clinical aspects of project team work to ensure compliance with internal policies and procedures and international standards (e.g., cGCP).
- Member of the leadership team partnering with other leadership team members to support the goals and objectives of vaccine development and introduction.
- Develop strong partnerships across the leadership team to ensure overall integrated development and introduction tactics for the projects.
- Provide overall strategy for the clinical functional area within risk assessment and regulatory pathways (the latter in collaboration with the Global Head, Regulatory)
- Lead the development and creation of norms, processes, standards, and documentation to ensure quality of clinical research and operations support to projects with a strong scientific component.
- Manage the clinical team to develop and review clinical development plans, protocols and amendments, investigator brochures, clinical sections of IND/IMPD filings, clinical study reports, and manuscripts.
- Provide clinical safety oversight, including development of risk management plans and ongoing review of safety in clinical trials and post-authorization pharmacovigilance.
- Evaluate safety, immunogenicity, and efficacy data from ongoing and completed human clinical studies
- Interact with partners to provide input, oversight, guidance, and evaluations of clinical development plans.
- Lead interactions with global health authorities and partners.
- Ensure timely and adequate talent resource allocation across vaccine development projects and activities.
Recruit, supervise, coach, and develop staff.
The Successful Applicant
Successful candidate expected to match the following criteria:
- 15+ years of industry or field vaccine clinical research and development; industry experience preferred
- Bachelor's degree in a scientific discipline and an advanced degree (e.g., MD, DO, DVM, PhD). Substantial experience in medical research (basic, applied and/or field research), preferable in infectious diseases.
- Demonstrated clinical development experience designing clinical study plans as well as integrated product development and life cycle management plans in a global setting
- Experience and success in conducting clinical studies on a global scale, particularly in low income countries (i.e., multi-centre studies conducted in multiple geographies).
- Internationally recognised clinical expert (with scientific/medical recognition) who has demonstrated ability to interact productively with and attract top external investigators.
- Demonstrated personnel leadership and management skills at a senior management level, namely recruiting and hiring staff and consultants; coaching, mentoring and developing employees; and teaching core values and upholding professional culture.
- Reputation as a flexible team player with ability to forge consensus in a project-focused matrix organisation and align with various other vaccine leadership
- Able to operate and adapt successfully in an ambiguous and frequently changing environment
- Outstanding technical, written, verbal, and interpersonal communication skills
- Prefer global management experience across multiple time zones and cultures
What's on Offer
Successful candidate will be offered competitive salary and bonus package along with the opportunity to develop within the team of professionals and bring COVID-19 Vaccine to Global Public