Applications Development Director jobs in Massachusetts

Senior Medical Director, Metabolism/Obesity, Early Clinical Development, CVRM

Are you an experienced endocrinologist/obesity specialist with clinical expertise in the management of patients with metabolic diseases including obesity, type 2 diabetes mellitus(T2DM), and metabolic- associated steatohepatitis (MAS)H and do you have well-developed clinical research experience? Would you like to be part of a talented and high peforming team of clinical research professionals, clinical scientists, and physicians who are translating rigorous scientific discoveries into early phase clinical development plans and clinical studies across a wide range of chronic and debilitating diseases?

This role will be located at our Global Research and Development (R&D) site in Boston, Massachusetts, USA.

At AstraZeneca, we’re dedicated to being a Great Place to Work with an inclusive and diverse team who work in a solution-oriented, trusting, and collaborative work environment.  We are dedicated to improving the health care and quality of life for patients across a wide range of diseases and disorders by developing innovative therapies that address unment clinical needs and provide clinicians with novel evidence-based treatment options to optimize the care of their patients.

Who We Are

In the Cardiovascular, Renal & Metabolism (CVRM) Early Clinical Development team, we are investigating the drivers of CVRM disease progression through ground breaking scientific methods and data-driven drug discovery approaches. In this context, we are investigating a wide range of different drug modalities from our rich CVRM portfolio of componds across diverse metabolic patient populations including obesity, T2DM, and MASH.

Early Clinical Development (ECD), part of the Early CVRM organization, is where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies and accelerating human target validation while collaborating closely with our late phase clinical development and regulatory colleagues who guide our pivotal phase 3 clinical studies. We are a diverse team of experienced physicians and clinical scientists who collaborate to delineate early phase clinical development strategies, design innovative phase I-IIb clinical trials, develop and validate novel surrogate endpoints, and translate scientific ideas to proof of concept studies in targeted patient populations.

We are recruiting a Senior Medical Director Physician, focused on Metabolic Diseases and Obesity. In this role, you will have the opportunity to work at the forefront of early clinical and translational research within CVRM. In a multidisciplinary environment, you will play a key role in progressing a rich and diverse pipeline of both small and large molecules in numerous active clinical programs.

What you’ll do

You will be responsible for managing and contributing to early phase I-IIb global clinical trials and related clinical research projects for compounds that are targeting obesity,T2DM and MASH as well as serving as an expert on the design, conduct, monitoring, data interpretation, and reporting of these studies. Additionally, you will work on cross-functional teams within our ECD group and across the broader early CVRM organization that are framing our strategies and development plans for compounds that are targeting CKD, CVD, dyslipidemia, and heart failure.

In this role, you will contribute to 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 and ensure that all clinical programs under your review are scientifically rigorous, clinically sound and valid, are operationally successful, and adhere to Good Clinical Practice and regulatory requirements
• Collaborate closely with other groups within the early CVRM therapeutic area to provide expert clinical input into pre-clinical scientific activities such as target selection, lead generation and optimization, clinical pharmacology, in vivo animal studies, in vitro studies, and drug formulation and manufacturing
• Work with a highly capable team of physicians and clinical scientists who design scientifically thorough, innovative, and efficient early phase clinical study protocols that are aligned with the pre-clinical scientific findings and clinical development plans for each compound, while ensuring seamless transition of early clinical programs to late stage development
• Contribute to interactions with regulatory authorities and governmental research organizations globally related to our early phase clinical programs and studies
• Assist with the preparation of various official and regulatory documents for Regulatory Authorities and other agencies, such as Dossiers, CTAs, INDs, Safety, and annual reports
• Contribute to efforts to certify and validate the scientific evidence for non-clinical, surrogate endpoints used in our early phase metabolic clinical studies including imaging, digital, and biomarker endpoints
• Serve as an internal and external scientific expert to communicate and disseminate the scientific accomplishments of our early clinical development team through internal workshops and forums, presentations at scientific meetings, and scientific publications
• Contribute to interactions with key external clinical and scientific experts for metabolic disease and translate input from external advisors into our clinical development plans, scientific discovery efforts, and regulatory interactions
• Contribute to ongoing efforts to improve, enhance, and evole the operational planning and execution of our early phase metabolic clinical studies, including developing innovative approaches for engaging and supporting clinical trial sites in our key countries and regions to perform well in our early phase clinical studies

Essential for the role

We believe that you are a Medical Doctor with specialty clinical training in endocrinology, or obesity medicine, who has well-established clinical expertise in the treatment of metabolic disorders with a minimum of 7-10 years of clinical research experience, either in the academic research environment or in the pharmaceutical/biotechnology industry. You will need to have well-developed interpersonal skills as well as a highly collaborative approach to the work that we do, including:

• A robust clinical research experience and scientific publication record
• Early phase clinical/translational research expertise, including experience in designing, monitoring, performing and interpreting early phase clinical trials and solid knowledge of biomarkers, surrogate endpoints, biostatistics, and safety reporting

Why AstraZeneca?

Here, we need leadership at every level – Physicians who not only have expertise, but also the ability to build a case, engage multiple partners, and communicate effectively with different audiences.Early clinical development is at the forefront of discovery of new medicines for patients with high unmet need. With that kind of remit comes great responsibility. 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, such as extra paid Holiday, Private Medical Benefits, On-site exercise and much, much more.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Welcome to apply!

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

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.

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