Amgen Indication Team Lead (Senior Manager Study Management ) in Thousand Oaks, California
Few careers offer the chance to make a difference in people’s lives. Take advantage of the opportunity at Amgen, the world’s largest biotechnology company. With global manufacturing operations and clinical development sites on three continents, Amgen is focused and committed to making our products available to improve patients’ lives through innovative science.
Amgen’s Early Development group is looking for an Indication Team Lead (Sr. Manager Study Management) to lead the clinical operational strategies, support development of CDPs and oversee the planning and operational execution of multiple early clinical development molecules/programs in phase 0 – 1/2. The Indication Team Lead is therapeutically aligned (oncology, cardiovascular, inflammation, neuroscience, metabolic disorders) and serves as a consultant and advisor for Global Early Clinical Development Managers (GECDM) and Early Development Leads (EDL) within their respective TA. The Indication Team Lead is accountable for functional management including recruiting and developing a high-quality Early Development team and supports resource planning within their respective TA.
Lead and oversee the development and execution of the operational strategies for multiple programs within their Early Development respective TA; Provide strategic operational input to program CDPs, TPP (target product profiles) and study designs.
Lead clinical operations teams to ensure effective development implementation and execution of clinical trials in accordance with SOPs, GCP and regulatory guidance.
Accountability at indication level, ensuring strategic alignment, consistency, and successful risk mitigation
Building Program/platform/indication expertise with proficiency and consistency; Cross-functional collaboration with key stakeholders and Leaders
Identify strategic business requirements to support their respective indication program needs.
Participate in KOL engagements
Participates in initiatives to drive department operational strategy and continuous improvement
Manages and develops reports
Basic Qualifications :
Doctorate degree and 2 years of Clinical experience
Master’s degree and 6 years of Clinical experience
Bachelor’s degree and 8 years of Clinical experience
Associate’s degree and 10 years of Clinical experience
High school diploma/GED and 12 years of Clinical experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications :
10+ years work experience in life sciences or medically related field
6+ years direct line management experience
6+ years of bio-pharmaceutical clinical research experience in early stage program development obtained working in a biotech, pharmaceutical or CRO company
Degree in science related field
Previous experience in managing clinical programs
Substantial experience in biotechnology and/or pharmaceutical clinical research with responsibilities for major aspects of strategic planning, organization, implementation, and delivery of clinical programs
Demonstrated success in managing complex early stage clinical program activities. Experience in FIH/phase 1 clinical trial design, regulatory submission package, execution, and reporting of phase I safety / pharmacology studies
Demonstrated understanding of translational medicine and the complexities and recent developments in FIH adaptive design approaches / clinical pharmacology and the implications for drug development
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
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
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.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.