Director, Early Clinical Development, Imaging CVRM

Are you an experienced clinical scientist with experience across clinical trials in cardiovascular disease and clinical imaging? Would you like to make a difference where science meets the patient? Join us to develop the ground-breaking medicines of the future for Cardiovascular, Renal and Metabolic diseases!

In Cardiovascular, Renal & Metabolism (CVRM), we are investigating the drivers of CVRM disease progression through groundbreaking scientific methods and data-driven drug discovery and development approaches. In this context, the Early Clinical Development team are investigating a wide range of different drug modalities from a rich CVRM portfolio. Our teams focus upon delivering innovative, early phase programs, accelerating human target validation and clinical line of site, while collaborating closely with late clinical development and regulatory colleagues who guide pivotal clinical studies.

We are looking for an experienced clinical scientist with clinical research experience in cardiovascular disease and clinical imaging. Your ambition to improving patients’ lives will involve you in a team working in a multidisciplinary environment, driving the early-phase clinical development of novel innovative therapies in CVRM diseases.

What you’ll do

• As a clinical scientist with a focus on imaging, your core accountability will be scientific support for the development and execution of project clinical strategies based upon your expertise including the latest thinking about mechanisms of disease, diagnostic approaches, current treatment options, drug development trends, and regulatory requirements in relevant disease and therapeutic areas. Your imaging experience will provide insight and knowledge on the use, implementation and handling (analysis output) of CTA, MRI, and Echo imaging data including translation of pre-clinical to clinical imaging endpoints. In collaboration with other functions, you will ensure operational excellence in advanced imaging endpoints in clinical studies, including the review and approval of imaging charters, specifying imaging specific criteria for site selection, data transfer specifications, imaging specific data capture forms, and the tracking of image progress during studies by review of monthly progress reports.

• You will contribute to early phase clinical trials and related clinical research projects, serving as an expert on the design, document generation, conduct, monitoring, data interpretation, and reporting of these studies. You will also support regulatory documentation, liaise with discovery scientists, regulatory, clinical and commercial colleagues, developing and managing external collaborations, and developing a deep knowledge of the literature pertaining to the product(s) under development.

Working with cross-functional, geographically dispersed project teams we will rely on you to:

• Work collaboratively with teams of physicians and clinical scientists who design scientifically thorough, innovative, and efficient early studies that are aligned with pre-clinical scientific findings and clinical development plans for each potential therapy, while ensuring seamless transition to late-stage development

• Collaborate closely with other groups within early CVRM to provide expert input into pre-clinical scientific activities such as target selection, lead generation and optimization, pharmacology and in vivo/in vitro studies

• Contribute to the preparation, review and maintenance of project documents including those for regulatory authorities

• Support interactions with regulatory authorities, governmental research organizations and scientific partners related to our early phase clinical programs and studies

• Enrich efforts to certify and validate the evidence for surrogate endpoints used in our early phase clinical studies including imaging, digital, and biomarker endpoints

• Serve as an internal and external expert to communicate and disseminate accomplishments through internal forums, presentations at meetings, and scientific publications

• Facilitate interactions with key clinical and scientific experts and integrate input from external advisors into our clinical development plans, discovery efforts, and regulatory interactions

• Support efforts to enhance planning and implementation of clinical studies, like developing innovative ways for engaging and supporting clinical trial sites involved in our studies

Essential Qualifications:

• Master’s degree

• 2+ years of experience with validated experience working in an early clinical trial/research setting including preparation of documents supporting clinical trials.

• Experience in writing clinical synopsis/protocols, regulatory materials and supporting documents.

• Experience in assisting in the design and execution of clinical studies as well as researching patient characteristics, treatments and care.

• Clinical scientific and operational knowledge in clinical cardiovascular imaging

• Good publication track record

• Track record of strong delivery focus, excellent communication skills and ability to collaborate successfully on global cross-disciplinary teams

Desired Qualifications:

• PhD or other advanced degrees

• Ability to work collaboratively with internal and external partners

In Office Requirement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. This role is available in our Boston MA or Gaithersburg MD offices. Remote or travel constructs are not available for this position.

The annual base pay for this position ranges from $185,606 to $278,410. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. ​

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.