Senior Global Development Scientist, Director (Gaithersburg, Maryland)

This job is with AstraZeneca, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Job Title: Senior Global Development Scientist

Gaithersburg, MD or Cambridge, MA.

Introduction to role:
Are you ready to shape late-phase oncology trials that reach patients worldwide and change standards of care? In this role, you will be the clinical science driver behind pivotal studies, turning strategy into protocols and data into decisions that matter for patients, clinicians, and regulators.

You will partner closely with a counterpart physician and an empowered cross-functional team to design, deliver, and interpret complex global studies. From first concept through study delivery and registration, you will influence protocol integrity, enable robust recruitment, and translate evidence into clear recommendations for investment and approval. Can you envision yourself guiding high-stakes Go/No-Go moments and accelerating therapies to patients?

Accountabilities:
- Clinical Strategy Translation: Convert program strategy into high-quality study concept documents, protocols, and related materials (including ICFs, CRFs, TFL shells), ensuring alignment with clinical practice, the evolving scientific and regulatory landscape, and program objectives.
- Protocol Ownership and Integrity: Be accountable for the scientific rationale and clinical integrity of protocols and clinical plan components; deliver final protocols and secure governance approvals, partnering with the Study Physician, GCPL, and GCH for technical reviews at bodies such as DRC and PRC; may lead and approve the Medical Oversight Plan.
- Trial Delivery and Recruitment: Drive timely study initiation and execution with Clinical Operations, Program Management, GSTs, SMM, supply chain, and sample management; proactively flag recruitment risks, propose mitigations, and support implementation; provide clinical input to feasibility questionnaires and consult on country and site selection; respond rapidly to site queries and EC/IRB requests.
- Safety and Medical Monitoring: May lead study-level medical monitoring and safety reviews to protect participants and data quality throughout study conduct.
- Data Review and Decision-Making: Lead high-level clinical data reviews and interpretation; craft content for governance interactions seeking Go/No-Go decisions; lead development and delivery of the clinical study report.
- Regulatory and Registration: Support health authority interactions; contribute clinical components for regulatory and EC/IRB submissions; provide clinical input to registration packages (e.g., NDA/BLA); collaborate on launch, branding materials, and publications.
- External Engagement and Feasibility: Partner with investigators, KEEs, MSLs, and SMMs to optimize study design, feasibility, and recruitment strategies; contribute to advisory boards; develop and deliver investigator and monitor training.
- Cross-Functional Leadership: Serve as a core GST member representing Clinical Development; embed cross-functional input from global medical affairs, marketing companies, commercial, and other stakeholders to unlock study success.
- Process Improvement and Mentorship: Provide expert input or lead process improvements; contribute to cross-asset or cross-tumor working groups; mentor and develop less experienced team members and, as appropriate, provide line management.

Essential Skills/Experience:
- PharmD, Ph.D. degree in life sciences, or MD preferred. Strong preference for Oncology experience
- 7+ yrs Industry or academic experience in drug development required.
- Possesses sound foundational knowledge of FDA and other major country regulations.
- Possesses detailed knowledge of Good Clinical Practice (GCP) other regulations governing clinical research.
- Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.
- Significant oncology therapeutic experience to be sought out or serve as a resource to other internal/external

Desirable Skills/Experience:
- Proven ability to independently lead components of complex clinical development plans, related documents, methodologies, analysis plans, and evaluation tools.
- Demonstrated ability to drive protocol design, writing, and implementation to meet GCP, ICH, and internal quality standards.
- Experience leveraging state-of-the-art methodologies in clinical research, including novel endpoints, biomarkers, adaptive or innovative trial designs, and advanced analytical approaches.
- Strong communication and presentation skills to engage internal governance committees and external audiences such as investigator meetings, IDMCs, and scientific conferences.
- Experience contributing to and leading clinical reports and integrated summaries for complex global projects.
- Experience leading study-level medical monitoring and safety reviews.
- Success operating in global, matrixed teams across multiple countries and time zones.
- Track record of mentoring or managing clinical staff and shaping team performance.
- Ability to influence and build consensus across diverse stakeholders including operations, biostatistics, regulatory, safety, and commercial partners.
- Advanced oncology therapeutic area expertise across multiple tumor types.

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. 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 unique and ambitious world.

Why AstraZeneca:
Here, your clinical judgment fuels real progress against cancer, supported by a deep, diverse pipeline and collaborators who unite science and execution at pace. You will work at the leading edge with rich data, novel biomarkers, AI-enabled insights, and bold trial designs-surrounded by colleagues who value kindness alongside ambition and who learn from both breakthroughs and setbacks. We bring the best of academia and industry together, convening unexpected teams to unlock decisive evidence and translate it into therapies that change lives.

Seize this chance to steer pivotal oncology studies and accelerate the next generation of therapies to patients-share your profile today and help shape what comes next!

The annual base pay (or hourly rate of compensation) for this position ranges from $ 233,586.40 - 350,379.60 USD Annual. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Salary : Negotiable