Executive Medical Director, Early Development, Oncology - Amgen

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 Medical Director Early Development, Oncology

Live

What you will do

Lets do this. Lets change the world.

Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms Bispecific T Cell Engagers (BiTEs), Bispecific Antibodies, and Small Molecules across many targets and more than a dozen tumor types. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients.

In this vital role, the Executive Medical Director will serve as an Early Development Oncology Portfolio lead for key assets in the Amgen portfolio and be responsible to represent Oncology Clinical Development. They will serve as the principal representative for an early development portfolio to a range of audiences, including executive leadership, development partners, and global regulatory agencies.

They will develop and translate oncology development program strategies into the design and implementation of clinical studies that can be executed without compromising scientific rigor. The Executive Medical Director will report into the Vice President, Early Development.

Responsibilities

• Develop an Oncology Early Development team in collaboration with Early Development Oncology Therapeutic Area Head

• Represent Amgen at joint development committees, at academic institutions as well as with global regulatory agencies

• Ensure the best way to develop and prosecute an early development portfolio

• Drive the timely execution of multiple assets and studies within their early development portfolio

• Ensure strategy and execution, and partner closely with Product Team Lead (PTL), study management, biostatistics, data management, and research colleagues

• Partner closely with regulatory leaders to support regulatory interactions and develop regulatory strategies

• Keep major stakeholders and other senior management updated as the portfolio evolves and matures

• Guide their team to think broadly as they create innovative portfolio development strategy options. Ensure all avenues and options have been explored and weighted before final recommendations sent to review by senior leadership

• Oversee activities related to planning for studies including execution and oversight of study outlines and Protocols for early development clinical studies

• Mentor, coach, and supervise the performance of direct reports to build highly skilled, diverse, and inclusive teams, leading and motivating staff in a complex, multi-functional matrix environment

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Executive Medical Director we seek is an experienced leader with the following qualifications.

Basic Qualifications

• MD or DO from an accredited medical school AND

• Five (5) years of industry or academic research AND

• Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• MD, PhD, MBBS plus accredited residency in relevant sub-specialty, board certified or equivalent

• Subspecialty board eligibility/certification or equivalent in Oncology or Hematology

• Eight (8) or more years of clinical research experience and/or basic science research experience

• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

• Ten (10) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities

• Proven success record in how to conceptualize, design, conduct, and analyze early development clinical trials

• Ability to anticipate problems and find creative solutions

• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints

• A record of high-quality peer-reviewed publications

• Experience functioning as a medical expert in a complex matrixed environment

• Previous experience in conducting translational and/or clinical research for both small molecules and large molecules

• History of solving problems while exhibiting judgment and a balanced, realistic understanding of issues including the ability to anticipate problems and find creative solutions

• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements

• Knowledgeable in current and possible future, trends, technology, policies, practices and information of the competitive landscape of oncology development and global health authority requirements for oncology drug approval

• Demonstrated ability to organize and lead expert Clinical Research Advisory Panels

• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

• Understanding of resourcing and budgeting

They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

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.

The annual base salary range for this opportunity in the U.S. is $335,719 - $392,292.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

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.

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 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.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.