Job Information
Amgen Development TA head in Shanghai, China
Purposes of the job are,
As management role, lead the development team activities of specific TA (therapeutic area) by providing high quality guidance/advice on China development strategy and oversee projects from early development to MAA filing.
Oversee overall clinical development programs/activities to maximizing the value of pipeline in relevant TA in China and ensure deliverable of key development milestones.
Lead the enhancement of the organizational culture, working model and process improvement in Dev TA
Accountable for ensuring function capabilities to build and lead a ‘Best in Class” China Development team
Responsibilities include,
Oversee and provide direction to development activities in relevant TA
Work closely with relevant Global Development TA heads, Global Development Lead (GDL) and enhance collaboration between China and Global
Oversee and advise China physicians and China Product Team Leads to develop strategy, tactics and challenging / achievable goals and input into the global development organization.
Ensures excellence in both strategy and execution, partners closely with local internal and external stakeholder.
Securing the quality of documents in clinical parts of CTDs
Keeps major stakeholders and other senior management updated as the portfolio evolves and matures.
Assessing risk and identifying issues, conflicts, or gaps across relevant TA portfolio
Managing resources and budget for relevant TA.
Hiring, coaching, mentoring team members and developing their capabilities to achieve high level of performance and productivity.
Plans to adequately resource the team as the portfolio grows and matures.
Provide opportunities for career development of team members.
Ensures that the best practices and learnings from the TA programs are shared across the team and promote a vibrant collaborative atmosphere.
Is aware of and provides challenging stretch assignments that are aligned with each person’s career aspirations; hold frequent feedback and development discussions.
As member of China Development Leadership Team, work closely and collaboratively with other functions head and members with one team spirit to serve Amgen development goal, including but not limited to Medical Affair, Regulatory Affair, Biostats, Clinical Operation, Program Management etc.
Represent Amgen to external stakeholders (HCPs/ Health Authorities/Partners/Industry Associations) as a Clinical Development Expert in specific TA; Work in related “Development Alliance/Partnership” with partners if needed.
Qualifications
10 or more years of early and late phase clinical development experience including multiple NDA filing works in multiple TA in the biopharmaceutical industry. (a few years equivalent experience e.g. as investigator in hospital is also acceptable)
Clinical Medicine degree (M.D.) and PhD is preferred; or Clinical Medicine (M.D.) degree with an equivalent experience of master’s degree
Fluency in English, both oral and written communications
Business Chinese skill, both oral and written communications
3 or more years leadership and people management experience in clinical development or related functions
Knowledge
In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials.
Medical knowledge in the relevant therapeutic area
Sound scientific and clinical judgment.
Experience in leading Clinical Development and NDA filing
Experience with clinical study management and conduct
Understanding of China regulatory agency organization, guidelines, and practices and ability to negotiate with these groups.
Understanding of new drug product lifecycle and commercialization process with understanding of other functions; including but not limited to Clinical Operations, Commercial, Regulatory, and Medical Affairs, Value Access and Policy
Knowledge of GCP, NMPA regulations, guidelines and compliance
History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
Ability to anticipate problems and find creative solutions.
Competencies
Demonstrates Amgen Values and Leadership Attributes
Understand, articulate, and optimize value and cross-functional outcomes for Amgen.
Amgen First
Objective view of opportunity, value, and risk, grounded in reality, guided by local insight; clearly and succinctly communicated
Recommendations include realistic options and impact
Ownership of results and efficient & effective execution
Fully participate
Flexibility, creativity and innovation based on program constraints
Influence to the best cross-functional outcome
Effective utilization of DAI framework
Appropriate escalation of issues
Able to lead altitude-appropriate discussions on strategy and tactics
Open-minded to multiple viewpoints
Manage healthy debate and conflict
Excel at developing team, coaching, and mentoring