Strategic Clinical Development Director - Remote US

Job Description

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Remote CONUS AK HI

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

Auto req ID

418465BR

Minimum Education Required

Bachelors

Job_Category

Pharmaceutical

Additional Qualifications/Responsibilities

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

180,810.00 USD - 221,488.00 USD

City*

United States

State*

N/A

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Amgen