Amgen

Executive Medical Director, Global Development Lead

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jul 04, 2021
Ref
R-117551
Required Education
Bachelors Degree
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Executive Director, Global Development Lead

Live

What you will do

Lets do this. Lets change the world. In this vital role as The Global Development Lead (GDL) you will report directly to the Vice President, Global Development for Hematology/Oncology and have the opportunity to contribute to the development of global product strategy, lead global development strategy from Phase 2 and beyond and lead the design and implementation of the Total Evidence Generation Plan (EGP), through the effective leadership of the Evidence Generation Team (EGT) for the Bemarituzumab program.

Responsibilities Include:

  • Provide deep medical insights in disease biology, product attributes, and clinical trial design into the development of Product Team strategic options and Global Product Strategy
  • As a core member of the Product Team, contribute to the Global Product Strategy and represent the unified, cross-functional EGT voice in program strategic options
  • Lead the EGT in the development and implementation of the total evidence generation package for the asset (e.g., registrational, non-registrational, real world evidence)
  • Define product profile through design, execution, and interpretation of clinical evidence
  • Collaborate cross functionally and cross regionally to ensure that the EGS and EGP balances multiple stakeholder needs with product attributes and delivers globally relevant data throughout the product lifecycle
  • Lead development of study documents (e.g., Study Outlines, Protocols, RACT, DMP) for global clinical studies, including Phase 1B and Phase 3 registrational studies
  • Partner with regulatory to lead registrational activities, including regulatory interactions, development of documents for regulatory submission and discussion, and filing activities
  • Partner with Global Development Operations and local organizations (DOMs/Country Medical Directors) to ensure timely delivery of high quality global clinical data
  • Support the Global Medical team in capturing and translating local / regional data gaps into actionable EGPs, in alignment with global product strategy and global EGP
  • Partner with GRAAS/ GV&A to define and maintain product benefit/risk profile and facilitate global registration and reimbursement
  • Provide medical / scientific leadership and input into:
    • Key regulatory/safety deliverables (e.g., core labeling and global regulatory submission documents, periodic safety update reports)
    • Regulatory responses; Represent all clinical and development aspects during regulatory authority meetings (e.g., advisory committee meetings, label negotiations)
    • Health authority queries and benefit/risk assessments throughout the product lifecycle
    • Global Value Dossier, HTAs and payer negotiation
  • Partner with Global Medical organization and contribute to:
    • Global evidence communication through development of Global Publication Plans
    • Global Core Content (e.g., disease state, clinical trial letters) creation
    • Share total evidence and biologic insights with: internal stakeholders to inform their strategies/deliverables; external stakeholders to seek expert advice to inform development strategies
  • Manage relationships with alliance partners to ensure alignment and execute on development strategy and evidence generation plans
  • Provide strategic medical input into Licensing and Business Development strategies
  • Manage a high performing Evidence Generation Team and develop staff
  • Mentor, coach, and oversee the performance of direct reports, provide input into performance of EGT members
  • As the clinical expert on the product, communicate the total evidence and biologic insights with internal stakeholders to align & inform their strategies, and with external stakeholders (KOLs / investigators, regulators, and payers) to shape the practice of medicine

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Oncology Development professional we seek is a Leader with these qualifications.

Basic Qualifications

  • 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

Preferred Qualifications

  • MD plus accredited residency in Oncology, board certified or equivalent
  • Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
  • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
  • Previous management experience
  • Prior experience in clinical practice and /or development in GI (Gastrointestinal) medical Oncology
  • Previous experience in regulatory interactions and filing activities for Oncology products

Knowledge and Competencies

  • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
  • In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
  • Medical Knowledge in Gastrointestinal (GI) medical Oncology
  • Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups
  • Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
  • Understanding of new drug commercialization and business practices
  • Understanding of resourcing and budgeting
  • Proven ability to lead, manage, and motivate others in a complex, multi-functional matrix environment
  • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
  • Demonstrated ability to organize and lead expert Clinical Research Advisory Panels
  • History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

  • Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Amgens Commitment to Our 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.

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 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 organizations 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

We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment.

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.

MEANINGFUL IMPACT. To serve patients. We are all deeply committed to our mission: to serve patients. And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose.

INNOVATIVE: Stretch yourself at the cutting edge. Youre poised to have a high impact in the new Bio century, Amgen offers our people interesting and challenging work.

REPUTATION. Be behind world-renowned products and services. With our industry reputation and strong product pipeline, you can take pride in working at Amgen.

COLLABORATIVE. Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.

REWARDING. Get a fair share in success. Everyones contribution is recognized and strong performance is rewarded.

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.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.


Join Us

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.