Strategic Clinical Development Director

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Strategic Clinical Development Director

Live

What you will do

Let’s do this. Let’s change the world. In our mission to serve patients, speed is absolutely critical. The Strategic Development Organization (SDO) within the Center for Design and Analysis in the Global Clinical Development organization is rapidly expanding our hiring initiatives and we are excited to unite with the most passionate and brilliant clinical development talents who want to join our team – working toward our mission of advancing high potential programs for cancer patients around the world.

The Strategic Development Director (SDD) within the SDO works across our

clinical development pipeline to provide teams with expertise and leadership in the design of innovative clinical development program strategies and clinical trials. Embedding with asset teams and partnering with development leaders during program strategy and subsequent clinical development planning, the SDD brings a holistic knowledge of the end-to-end clinical development process and the drug development/clinical landscape to promote the generation of strategic development options. Combining experience in the scientific design of clinical programs and studies, clinical data, regulatory science and product commercialization with decision science-based approaches, the SDD promotes the generation of innovative product development strategies and study designs. The SDD partners closely with the data and 'omics roles in the SDO, as well as Directors of Statistical Innovation within the Design and Innovation group, to develop and promote the adoption of cutting-edge, data-informed clinical design approaches to ensure the most appropriate and efficient development of our pipeline.

Other key responsibilities include:

• Support the development and delivery of key components of the Evidence Generation Plan/Clinical Development Plan
• Support complex development decision making throughout product development cycle. The SDD leads teams through a qualitative approach to create strategic development options through framing, issue raising and classification, decision hierarchy, and strategy table generation
• Liaises with other Strategic Development roles and statistical innovators to support strategic option generation and innovative trial design
• Identify value measures, trade-offs, risks, and gaps in asset development strategies
• Identify opportunities to apply innovation to development programs
• Bring the right functions together at the right time and integrate cross-functional input to facilitate end–to-end clinical development
• Objective leader that influences the adoption of novel or innovative approaches

Win

What we expect of you

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

Basic Qualifications:

• Doctorate degree PhD OR PharmD OR MD and 5 years of experience
• OR
• Master’s degree and 8 years of experience
• OR
• Bachelor’s degree and 10 years of experience

Preferred Skills:

• Strong facilitation, influencing, and negotiation skills
• 10 years of clinical research design experience in a clinical setting and in executing clinical trials
• End-to-end product development knowledge and experience
• Demonstrated experience in innovative study design approaches such as adaptive design
• Strong clinical landscape knowledge in areas of development interest for Amgen
• Appreciation of current regulatory and commercial landscape
• Ability to integrate and synthesize cross-functional input as it relates to evidence generation and apply decision science framework to facilitate data-driven decision making
• Experience with innovative development approaches and understanding of how/when to apply them (fit for purpose approach)
• Exhibits strategic and holistic approach to product development and is forward thinking
• Understands how data and analytics can inform study design, development options, and knows where/when to apply them
• Contextualizes data and objectives for analytical partners
• Leadership capabilities to guide and motivate others and drive deliverables
• Excellent verbal and written communication skills
• Experience of working in a consulting-style manner, rapidly building trust and integrating with teams

Thrive

What you can expect of us

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

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

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

#obesity

Salary Range