Amgen is seeking an Executive Medical Director, for a global, high priority Phase 3 inflammation program. The program is currently developing Tezepelumab, a TSLP inhibitor, in severe asthma and atopic dermatitis, in partnership with Astra Zeneca. Tezepelumab is a potential first-in-class medication blocking TSLP, an epithelial cytokine, critical in the initiation and persistence of airway/epithelial inflammation.
This position is located in Thousand Oaks, California.
The Global Development Leader will have an opportunity to shape the growing Inflammation therapeutic area and will report directly to the Vice President, Global Development for Inflammation.
Serve as the clinical lead for Amgen and contribute to the product strategy for Tezepelumab and represent Amgen development in interactions with our partner
Develop the global development strategy, participate in execution and communication of the global scientific/medical evidence plan for multiple indications; in partnership and collaboration with Astra Zeneca
Provide clinical/scientific input during the development and execution of clinical trials, including key observational studies
Provide clinical content input to: Regulatory interactions and documents, Safety interactions and documents, Materials to be used in Scientific Affairs and Commercial Organization
Seek global cross-functional collaborations to integrate broad medical, scientific, and commercial and payor input into the development program; in collaboration with partnership
Provide clinical input into safety and regulatory submissions/interactions and participate in regulatory interactions as needed
Participate in interpretation of clinical trial data and publication authorship, as appropriate
Develop key external relationships to foster research and support clinical development activities; make scientific presentation at advisory boards, key scientific meetings and governance meetings as needed
Identify new clinical research opportunities and support product life cycle management for new indications
MD or DO degree from an accredited medical school
Five or more years of clinical development experience in industry and academic clinical research AND
Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
MD with eight or more years in biopharma and versatile drug development experience in inflammation with accreditation in relevant sub-specialty (i.e. Pulmonology or Dermatology)
Knowledge of pharmaceutical product development, product life cycle, and commercialization processes, including but not limited to, clinical development, clinical operations, commercial and regulatory affairs
Experience and knowledge in designing, conducting and analyzing Phase 1, 2 and/or 3 clinical trials in inflammation/immunology
Experience of working in alliance/partnerships
Leadership and management experience in leading evidence generation teams with ability as a medical expert in a complex matrix environment
Regulatory and/or filing experience with familiarity with FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
Present ideas and document complex medical/clinical concepts in both written and oral communication
Interpersonal skills and problem-solving abilities while exhibiting judgment and a balanced, realistic understanding of issues and resolution path
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 skillsets, 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
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.
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.