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Global Development Scientist Director, Late Development Oncology

Location Gaithersburg, Maryland, United States Job ID R-230688 Date posted 03/07/2025

Are you ready to drive the next generation of cancer care? Are you passionate about pushing the boundaries of science with cutting-edge precision medicines? Then Fusion Pharmaceuticals, a leading oncology innovator and member of the AstraZeneca Group, could be the opportunity for you!

As a Global Development Scientist Director, you will play a pivotal role within the Clinical Project Team (CPT) and Global Study Team (GST), collaborating with diverse stakeholders to drive the clinical aspects of our programs. Your expertise will be essential in planning and executing phase 2 and later clinical studies, ensuring timely delivery and successful worldwide registration of our products. This role offers the opportunity to lead process improvement initiatives and mentor, all while adhering to the highest ethical standards.

Accountabilities

  • Work cross-functionally within clinical product teams (CPT) to ensure the clinical strategy—particularly for phase 2 and late-stage development—is translated into the development of study concept documents, study protocols, and related documents.

  • Develop relationships with consultants and key external experts (KEE), study sites, and utilize these relationships for protocol design feedback, study training, execution, and interpretation of results.

  • Ensure relevance and accuracy of clinical science underpinning phase 2 and late-stage clinical studies through detailed scientific review and consultation.

  • Provide clinical and scientific leadership and integrity for protocols and components of clinical plans.

  • Support or lead interactions with global medical affairs, marketing companies, commercial, and regulatory functions to ensure cross-functional input into protocols.

  • Contribute to technical review of protocols with governance bodies such as DRC and PRC.

  • Support health authority interactions as needed.

  • Contribute to the development of Medical Oversight Plan (MOP) and study-level safety reviews.

  • Engage proactively with MSLs to build strong partnerships with SMMs and KEEs for robust feasibility assessments and streamlined study execution.

  • Contribute to development and delivery of investigator and monitor training.

  • Review and interpret clinical data (HLRs) for governance committee interactions seeking Go/No Go decisions.

  • Support development of clinical components for regulatory and EC/IRB submission documents where marketing approval is warranted.

Essential Skills:

  • Required Life Sciences degree or equivalent

  • PharmD, Ph.D. degree in life sciences, or MD preferred. Strong preference for Oncology experience

  • Industry or academic experience in drug development required, with specific experience in phase 2 or late-stage clinical trials in oncology highly desirable.

  • Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.

  • General knowledge of medical monitoring, regulatory approval processes, pharmaceutical industry/R&D operations, marketing, and commercial fundamentals.

  • Ability to grow and maintain a high level of expertise in oncology therapeutic area, including experience with phase 2 clinical trial design and conduct.

Why Fusion?                                                                                 

Fusion Pharmaceuticals, a separate company that is part of AstraZeneca, is dedicated to transforming cancer treatment through the development of innovative radiopharmaceuticals. Our mission is to deliver targeted therapies that precisely attack tumor cells while minimizing damage to healthy tissue, leveraging cutting-edge technology and scientific expertise. As part of our team, employees benefit from the dynamic, collaborative environment of a specialized biotech, enhanced by the resources, global reach, and support of AstraZeneca. This unique partnership offers opportunities to work on pioneering oncology therapies, contribute to meaningful advancements in patient care, and grow within a forward-thinking and supportive organization. Fusion Pharmaceuticals is committed to fostering professional development, scientific innovation, and a shared purpose in the fight against cancer.

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com

#LiHybrid

The annual base pay for this position ranges from $196,778 to $295,167. 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.

Date Posted

04-Jul-2025

Closing Date

17-Jul-2025Our 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.

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.