Director Clinical Scientist Early Clinical Development, Cvrm R&D

Job Title: Clinical Scientist, Early Clinical Development, Cardiovasular, Renal, and Metabolism R&D

Location: In office with flexibility in Boston Seaport, Massachusetts

Are you an experienced scientist with clinical research experience in obesity, Diabetes Mellitus, liver disease, and/or metabolic dysregulation? Would you like to make a difference where science meets innovations in patient care, by being part of a dedicated and impactful team of clinical scientists and physicians who are translating meticulous scientific discoveries into early phase clinical development (EPCD) programs across a wide range of chronic and debilitating diseases?

AstraZeneca, is dedicated to being a great place to work with an inclusive and diverse team of hard-working colleagues who work in a results-oriented, trusting, and collaborative work environment. We are dedicated to improving the healthcare and quality of life for patients across a wide range of diseases and disorders; developing innovative therapies that address unmet clinical needs and that provide clinicians with novel evidence-based treatment options that will enable them to optimize patient care.

Who We Are

In Cardiovascular, Renal & Metabolism (CVRM), we are investigating the drivers of CVRM disease progression through ground-breaking scientific methods and data-driven drug discovery and development approaches. In this context, the Early CVRM Clinical Development team is investigating a wide range of novel drug targets across a variety of different drug modalities that are included in our rich CVRM portfolio.

EPCD CVRM Clinical Development is part of our discovery research department, and is where science meets patient care with a focus upon delivering innovative, EPCD programs and studies while collaborating closely with late-phase clinical development and regulatory colleagues who guide pivotal phase 3 clinical studies. We are a team of experienced clinical scientists and physicians who collaborate broadly to establish EPCD strategies, craft innovative phase I through phase IIb clinical trials, develop and validate novel surrogate endpoints, and translate scientific ideas into proof-of-concept studies in our targeted patient populations.

We are looking for an experienced clinical scientist with clinical research experience in metabolism-related disease s(e.g. T2DM, Obesity, MASH). Your ambition for improving patients' lives will translate into you working in a multidisciplinary, team-based environment, driving the development of innovative therapies in CVRM diseases. In this role, you will have the opportunity to work at the forefront of early clinical and translational research. This is an office-based role that is located at AstraZeneca's vibrant R&D site in Boston, Massachusetts (Seaport District) in the United States.

What you will do

As a clinical scientist your core accountability will be scientific support for the development and maintenance of drug project clinical strategies based upon your expertise including the latest thinking about mechanisms of disease, diagnostic approaches, treatment options, drug development trends, and regulatory requirements in relevant disease and therapeutic areas. You will contribute to EPCD trials and related clinical research projects for potential therapies that are targeting metabolic diseases, as well as serving as an expert on the design, conduct, monitoring, data interpretation, and reporting of these studies. Additional tasks include supporting regulatory documentation, collaborating closely with discovery scientists, regulatory, clinical and commercial colleagues, developing and running external collaborations, and developing a deep knowledge of the literature pertaining to the product(s) under development. Cross-functional team collaboration is key within EPCD, and across the broader early CVRM organization that are framing our strategies and development plans for potential therapies that are targeting major metabolic disorders. Because these disorders intersect with cardiovascular and kidney diseases and influence disease progression.

The chosen candidate will work with cross-functional project teams with multidisciplinary professionals from a diverse range of geographic locations. We will rely on you to:

• Contribute to the design and operational implementation of early-stage clinical projects ensuring programs under your purview are scientifically and clinically sound, operationally successful, and adhere to GCP and regulatory requirements

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

• Work collaboratively with highly capable teams of physicians and clinical scientists who design scientifically thorough and innovative, EPCD studies that are aligned with pre-clinical scientific findings and CDP's for each potential therapy, while ensuring seamless transition of ECDP programs to late- stage development

• Assist with the preparation, review and maintenance of project documents including those for regulatory authorities

• Contribute to interactions with regulatory authorities, governmental research organizations and scientific partners related to our EPCD programs and studies

• Contribute to efforts to certify and validate the scientific evidence for surrogate endpoints used in our EPCD studies including imaging, digital, and biomarker endpoints

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

• Contribute to interactions with key external clinical and scientific authorities for metabolic diseases and integrate input from external advisors into our clinical development plans, scientific discovery efforts, and regulatory interactions

• Contribute to continuous efforts to enhance operational planning and execution of EPCD studies, including developing innovative ways of engaging and supporting clinical trial sites in EPCD studies

Education, Experience and Skill Requirements

• Sucessful candidates will possess an M.D and/or Ph.D. educational qualifications (or relevant doctoral degree qualifications).

• Further advanced degrees and/or a solid publication track record are preferred

• You should be a scientist with a minimum of 3 years experience working in a clinical research setting preferably within the biotech or pharmaceutical industry

• You should have a demonstrated scientific knowledge in metabolism related diseases (e.g. T2Dm, obesity, MASH).

• Evidence of a strong collaborative working style and strong expressive and receptive communication skills are essential.

Why AstraZeneca?

Here, we need leadership at every level - leaders who not only have expertise, but also the ability to build a case, engage multiple partners, and communicate effectively with different audiences. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximize your skills, abilities and contribution. We offer a competitive salary and excellent benefits package.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our bold ambition! We are eager to know more about you. If you are interested to know more about us, apply now!

For more information, please contact the hiring manager, Darren Robertson - Group Director ECD Clinical Scientists at Darren.robertson@astrzeneca.com

Where can I find out more?

AstraZeneca Boston: https://www.astrazeneca.com/r-d/our-strategic-r-d-centres.html

CVRM at AstraZeneca: https://www.astrazeneca.com/our-therapy-areas/cardiovascular-renal-and-metabolism.html

This is what we're made of: https://www.youtube.com/watch?v=pmFx_jr2eFo&t=2s

Recent Publications: https://www.astrazeneca.com/publication.htm

Date Posted

10-Jun-2024

Closing Date

08-Jul-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.