Apply: Biopharma Integrated Development Solutions Head, China

PURPOSE

Direct, oversee and manage selling and delivery of integrated drug development strategy proposals and projects, primarily for China (local) emerging biopharma (EBP) clients with global ambitions (LGA), ensuring quality deliverables on time and within budget

JOB RESPONSIBILITIES

• Provide integrated strategic development solution to EBP LGA clients – for drug development into US, EU, Asia, Japan and other markets
• Collaborate with Global Strategic Drug Development, Global Consulting Services, Global Regulatory Affairs, Pricing and Market Access and relevant regional and affiliate commercial consulting, regulatory and other functions –- to provide integrated holistic strategic development solution to client
• Provide solutions to clients including regulatory (e.g. gap analysis), clinical (CDPs, TPPs), commercial (forecasts, valuations), pricing and market access strategy, and licensing/partnering strategy and support
• Scope project with client and coordinate groups to deliver integrated end-to-end proposal to client
• Accountable for overall delivery of proposal
• Leverage clinical, regulatory and business experience and acumen in identifying strategic alternatives and project approach to client questions/pain points
• Manage meetings with Regulatory Agencies
• Write and/or review a complete proposal and defend costs and timelines to clients
• Provide mentorship to junior colleagues and advise other colleagues on regulatory/clinical matters
• Plan and deliver workshops or presentations on Regulatory and Clinical development topics for conferences or publications
• Support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative
• Perform other tasks or assignments, as delegated by management

 
REQUIREMENTS

• PhD / Medical Degree in Science related discipline with minimum 10 years of relevant experience
• Experience in developing clinical protocols and advising on / creating clinical development strategy for US/EU
• Oncology and/or Cell and Gene Therapy experience an advantage
• Experience working in US or EU an advantage
• Experience dealing with US and / or EU regulatory authorities, including in early stage clinical development (pre-IND, IND)
• Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
• Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues. Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations
• Ability to exercise independent judgement taking calculated risks when making decisions

Reg No. 1103376
EBC Connect Pte Ltd
Licence no. 17C8975