HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s 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, Clinical Development, Rare Disease

Live

What you will do

Let’s do this. Let’s change the world. As an Executive Director, you will play an important role in planning and execution for all aspects of clinical drug development across Amgen’s clinical programs.

This Executive Director within Clinical Development will be involved with the full scope of the rare disease clinical drug development activities from discovery research through first in human, POC and Phase 3 or Phase 4 studies.

They will serve as the principal representative for global development within the rare disease therapeutic area to a range of audiences, including executive leadership, development partners, and global regulatory agencies.

This role will include global development leadership of one or more assets within the portfolio and require people management activities. The position must work closely with all members of the cross-functional product team to apply full clinical knowledge to successfully advance clinical programs, as well as the overall product strategy.

The Executive Director will report into the Vice President, Global Clinical Development, Rare Disease.

Responsibilities:

• Serve as the global development leader for a product team with an enterprise mindset

• Manage clinical development medical and/or scientific directors working on various clinical trials for the product

• Provide adequate oversight and mentoring of R&D personnel to design clinical development plans and protocols spanning all phases of development per indication in collaboration with product team members, key opinion leaders (KOLs) and CROs that are aligned with the target product profile

• Provide adequate oversight in the development of the primary and secondary endpoints for efficacy and safety as well as contribute to the biostatistics analysis plan, and clinical study reports (CSRs) along with biostatistics and other R&D colleagues

• Drive clinical development components in the writing and data interpretation of CSRs and oversee filing and registration activities

• Review, interpret and present clinical data to internal and external stakeholders

• Provide adequate oversight and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents

• Lead the evidence generation strategy as well as contribute to content of individual publications, abstracts, and presentations

• Maintain up-to-date knowledge of scientific and clinical published literature

• Interact with KOLs to assure implementation of latest clinical thinking and guidelines into the integrated product development plan

• Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, and consultants

• Provide input/review study start up documentations, e.g., CRF design

• Attend and provide clinical support for investigator and steering committee meetings

• Participate in due diligence and business development activities as needed

• Always operate within Compliance Guidelines

• Provide medical monitoring oversight for clinical trials as required

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

• Ten (10) or more years in biopharmaceutical sponsored clinical research is desirable

• Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable

• Solid understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology approaches

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

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

• Ability to analyze and interpret complex datasets

• Exercises initiative in meeting goals and drives innovation in projects

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 $325,814 - $370,473

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

Amgen’s 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.