Director Process Development Jobs in Frederick, MD

Job Title: Global Development Scientist, Director

Gaithersburg, MD

Introduction to role:
Are you ready to steer global hematology trials that turn bold science into life-changing medicines? As Global Development Scientist, Director, you will shape the clinical evidence that moves transformative therapies from hypothesis to registration and into the hands of physicians and patients who need them most.

You will join a global, cross-functional team pushing the boundaries of cancer research, leveraging multiple scientific platforms including immuno-oncology, tumor drivers and resistance, DNA damage response, antibody-drug conjugates, cell therapy and epigenetic approaches. Empowered to act on smart risks, you will translate strategy into decisive studies, accelerate promising assets across early and late development, and help define standards of care.
Can you see yourself leading pivotal protocols and turning complex data into clear, compelling conclusions for regulators and the medical community?

Accountabilities:

• Clinical Strategy Translation: Convert disease strategy and target product profiles into study concepts, protocols and key study documents in partnership with the Clinical Project Team and Global Study Team.

• Protocol Leadership and Governance: Provide the clinical and scientific leadership and integrity for protocols and clinical plans; own the final protocol and governance approvals, ensuring alignment with GCP, ICH and AstraZeneca quality standards.

• Trial Design and Delivery: Provide clinical/scientific input into early and late phase trials, including studies involving immunotherapy and cell therapy; partner with Clinical Operations to plan, recruit and deliver at pace, ensuring high-quality execution.

• Data Integrity and Interpretation: Lead clinical data review and medical data cleaning; synthesize efficacy and safety signals with the Global Development Medical Director; draw clear conclusions that inform go/no-go decisions and publications; deliver high-quality clinical study reports on time.

• Regulatory Evidence and Submissions: Prepare and contribute clinical content for global submissions (e.g., NDA/BLA) and lifecycle documents including Investigator's Brochure, DSUR, PSUR and regulatory responses to enable worldwide registration.

• Stakeholder Collaboration: Build strong internal networks across clinical, operations and quality, and form effective relationships with regulatory bodies and external service providers to maintain momentum and resolve issues quickly.

• Site and Investigator Engagement: Provide timely responses to investigational sites on ICF changes and protocol questions; plan and deliver effective investigator meetings and training to drive consistency and quality.

• Cross-Program Leadership and Improvement: Lead or contribute to cross-asset or cross-tumor initiatives, evaluate new opportunities and externally sponsored research, and drive process improvements that raise performance across the portfolio.

• Ethical and Compliance Leadership: Operate to the highest ethical standards in accordance with internal SOPs, local regulations and Good Clinical Practice.

Essential Skills/Experience:

• BS required; PhD in a scientific field, PharmD or MD is strongly preferred

• Minimum of 5 years of relevant experience

• Industry or Academic experience in drug development required with experience in malignant haematology clinical trials strongly preferred

• Sufficient technical knowledge (haemato-oncology background preferred) to be able to interact with confidence with internal and external partner

• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice 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

• Drug Development/Clinical Development Planning: Demonstrates a consistent track record to both independently complete, and lead peers in completion in components of sophisticated plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools

• Ability to drive/contribute to protocol design, writing and implementation

Desirable Skills/Experience:

• Experience contributing to or leading clinical components of NDA/BLA submissions and interactions with regulatory authorities

• Hands-on experience with immunotherapy, cell therapy and combination trial design in haematologic malignancies

• Proven leadership of cross-functional initiatives and process improvement projects across assets or tumor areas

• Track record of collaboration with external service providers and oversight of global studies across regions

• Experience planning and delivering investigator meetings and training; strong communication that influences diverse stakeholders

• More than 7-10 years of total clinical development experience is a plus

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, science and courage go hand-in-hand. You will work on one of the most dynamic pipelines in cancer, with access to unparalleled data, novel biomarkers, innovative endpoints and cutting-edge trial designs that span from early to late development. We bring unexpected teams together, empower people to speak up and make fast, evidence-led decisions, and value kindness alongside ambition. Your expertise will directly shape how new medicines are discovered, tested and delivered to patients worldwide, supported by a collaborative network of global experts and the resources to move quickly when the science is clear.

Ready to lead pivotal hematology development and turn bold science into decisive evidence for patients-send your CV to start a conversation about what you can achieve here.

The annual base pay (or hourly rate of compensation) for this position ranges from $203,709.60 -$305,564.40 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.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.