Head of R&D - China
- Bellevue, WA
The Head of R&D China will provide strategic and operational leadership for new drug development programs which integrates the individual’s extensive knowledge of the underlying science, innovative drug development, global and China-specific regulatory requirements, and the medical and patient advocacy community in China. Has comprehensive understanding of the commercial, research, regulatory and medical research goals and needs and related corporate activities. Will be accountable for efficient development, regulatory filings, product approvals and regulatory compliance in China, in collaboration with HQ functions. Will provide China site leadership and direct management of all R&D China functions (Regulatory, Clinical Development, Clinical Pharmacology, Clinical Operations, Pharmacovigilance, PMS, Portfolio & Business Operations, Business Development). Oversees activities in China across all drug development programs and across all therapeutic areas in collaboration with the Global development teams and aligns closely with China Business leaders. Accountable for supervising post-marketing safety and PMS studies for marketed products in China, in collaboration with the respective Global functions.
- Lead creating appropriate and challenging China drug development and regulatory strategy for all global programs and assure integration of the China project strategy into the Global Integrated Development Plan in collaboration with Global counterparts. Ensure implementing the China strategy and delivering the clinical trials in China on time with high standards utilizing appropriate operation models including CROs as applicable aligned with Global Biogen Teams as well as China Commercial and Business leaders. Achieve China registration filings targeting close alignment with Global filings.
- Be the Biogen R&D representative vis-à-vis Chinese regulatory agencies in the processes of Regulatory consultation, clinical trial notification, orphan drug designation and registration filing, and vis-à-vis academia. Ensure that Biogen’s medical, scientific and strategic messages are fully reflected in submitted documents and discussions.
- Supervise all Pharmacovigilance and Post-Marketing Study/ Surveillance activities for China. Ensure that RMPs, PMS plans, PIs and other documents for projects at the registration stage are developed in alignment with Global policy and China regulations.
Support post marketing products including execution of LCM plans.
Collaborate with Biogen China Business and Marketing and provide medical/scientific expertise.
Supervise innovative external research collaborations in China for potential licensing opportunities for Biogen Global.
- Lead annual budgeting process and financial management of the R&D China organization.
- Develop and maintain competence of R&D China organization through team building, hiring competent staff, setting goals and assessing performance, organizing individual and group education/ training and identifying and supporting/mentoring high caliber staff.
- Contribute to GSRS LT and the Global R&D Project Governance body
· At least 10 years of progressive responsibilities in global/ Chinese drug development in the biopharmaceutical industry, and a proven track record for clinical, scientific and strategic leadership in drug development and pharmacovigilance.
· Experience working with regulatory agencies (NMPA)
· Excellent communication skills (oral and written)
· Excellent organizational skills.
· Ability to influence outcomes, utilizing effective negotiation skills across functions and on the Leadership Team.
· Excellent leadership skills, as evidenced by a track record of hiring, retaining, developing and motivating top-tier talent.
- Language capability – must be Chinese and English
- Having a local scientific network and well versed with neuroscience thought leaders in China.
- In china for china/Asia – experience and interest in external innovation
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