Executive Medical Director Global Development
Amgen helped to develop the science used in making biologic medicines, and we remain a leader in designing and manufacturing new biologics. This expertise is now being applied to the challenge of making high-quality Oncology Biosimilars.
The Executive Medical Director will serve as Global Development Leader (GDL) for clinical development of key assets and be responsible for the Inflammation Biosimilars portfolio, as well as lead the biosimilars scientific affairs team. The GDL represents the unified global medical voice and is the single point of accountability for evidence generation and scientific communication. The GDL is also responsible for developing and executing the global scientific/medical evidence plan, collaborating cross-functionally and globally to integrate medical, scientific, and commercial input into the program and approving medical and scientific content of Regulatory, Safety, Scientific Affairs, and Commercial outputs.
Key Activities include the following:
- Oversee activities related to planning for studies across the product lifecycle for Biosimilars inflammation portfolio
- Interpret and integrate the results of research programs (e.g. study data, competitor data, publications) into the program strategy
- Deliver input to regulatory and safety groups for queries from regulatory agencies and negotiate with these groups
- Provide medical and scientific input into key deliverables (e.g., regulatory filings and interactions, protocols, clinical study reports, publications and reimbursement submissions)
- Issue strategic medical input into all aspects of the Commercialization process (pre-clinical through launch)
- Approve medical/scientific elements of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial materials and outputs
- Communicate safety and efficacy/effectiveness status of the product internally and externally
- Review, approve, and execute product specific publication plan as development lead
- Lead the Biosimilars Scientific Affairs team responsible for global scientific affairs and publication plan
- Manage the development and execution of global Biosimilars medical plan and regional partnerships
- Guide the development and execution of global publication plan
- Provide medical support for licensing activities and support partner relationships as needed
Leadership, Collaboration and Management
- Lead Global Development Team and represent the team in Multidisciplinary and Senior Management Interactions
- Collaborate on multidisciplinary product team with the Commercial Lead, Regulatory Lead, and Operations Lead
- Mentor, coach, and supervise the performance of direct reports
- Provide oversight and ensure alignment between clinical development and development operations.
- Supply medical/scientific support to other functions as appropriate
- Support regional needs for medical/scientific evidence generation
- Develop key relationships with global opinion leaders
- Development and execution of clinical trials
- Experience with chronic disease states in a variety of therapeutic areas
- Familiar with investigators or institutions in various therapeutic areas
- Experience with regulatory affairs and drug safety as well as publications, commercialization and business practice
- Leading and motivating staff in a complex, multi-functional matrix environment
- MD or DO degree from an accredited medical school AND
- Five or more years of clinical development experience in industry academic clinical research AND
- 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Accredited fellowship in relevant specialty or sub-specialty (eg. internal medicine, Rheumatology, gastroenterology), board certified
- Eight (8) + years of industry research experience
- Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO Company)
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.