Description
Amgen is searching for a Director, Diagnostic Strategy Lead located in China. This individual will be a member of the global Diagnostics team responsible for the development and implementation of Diagnostic (Dx) development strategy across therapeutic areas for the China market.
Integral to the ongoing success of Amgen’s growing pipeline, the Diagnostics (Dx) Group is responsible for the successful transition of a biomarker assay to marketed Diagnostic to support the clinical development strategy for regulatory approval and commercialization.
As such, the Dx group works closely with other functions within Amgen to identify the appropriate partners for diagnostic test development. We are looking for individuals with experience in driving end – to – end diagnostic development strategies and developing Dx life cycle management plans in China that align to the needs of their corresponding precision therapeutics programs across therapeutic areas. The Diagnostic Strategy Lead role will be a critical strategic role at Amgen requiring a breadth of technical and business communication expertise, influencing decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company. This individual will be working with the global and the local cross-functional teams to drive the development and execution of the Dx strategy and plan.
The primary responsibility of the successful candidate will be to develop comprehensive Dx strategies for the China market across therapeutic areas and to ensure those programs are fully aligned with global Dx and clinical development strategies.
Responsibilities:
+ Lead the development of the end–to–end diagnostic development strategies to support therapeutic product teams in China.
+ The development and successful implementation of global strategic diagnostic development life cycle plans, programs and initiatives to support approval and commercialization of diagnostics which will support the therapeutic life cycles.
+ Developing business cases, driving the strategic evaluation of diagnostic development options and technologies, diagnostic market landscape assessment in China.
+ Working with key cross-functional stakeholders to integrate diagnostic development, approval and launch strategies for the product teams together with third-party diagnostic partners and ensuring successful execution of the overall Dx strategy for China.
+ Work closely with local regulatory team to ensure that the Dx plan meets local regulatory requirements.
+ Ensuring that the diagnostic strategy incorporates global requirements for execution and success.
+ Working closely with global and regional marketing teams, and other cross functional partners and stakeholders, to deliver and implement diagnostic business strategies for China.
Basic Qualifications:
Doctorate degree and 4 years of pharmaceutical and/or diagnostics experience
OR
Master’s degree and 8 years of pharmaceutical and/or diagnostics experience
OR
Bachelor’s degree and 10 years of pharmaceutical and/or diagnostics experience
AND
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
+ 5+ years of experience in the Diagnostics industry
+ 4+ years of cross-functional leadership experience leading teams, projects, programs or directing the allocation of resources
+ Proven experience developing strategic initiatives and gaining stakeholder alignment at all levels in the organization
+ Highly effective presentation / communication skills at the senior / /executive management level
+ Experience in precision medicine development and / or in vitro diagnostics development
+ Experience in companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets
+ Knowledge and experience in clinical trial design
+ Experience integrating data from multiple sources and identifying critical process variables
+ Experience establishing and reviewing complex plans for multiple projects or activities. This includes planning / reviewing resource allocation, complex timeline development, risk identification / mitigation
At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.
Consistent with our core leadership value of “Develops the Best Team,” we are seeking leaders that prioritize the development of talent. As a manager, your first priority and primary role is to accelerate the performance and development of your team. We expect managers to exemplify strong leadership and champion self-awareness and career development Ways that you will display your leadership acumen in this role include:
+ Mentoring, coaching, and developing staff to build highly-skilled, diverse, and inclusive teams
+ Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities
+ Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business
+ Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement
+ Making accurate evaluations of your team’s skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages
+ Developing an understanding of your team’s career objectives and serve as a thought-partner in their career development plans
+ Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives
+ Resolving critical gaps in the organization’s internal capabilities and skill sets, including strategic external recruiting
+ Identifying diverse, qualified successors for key positions
+ Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
