Global Development Scientist, Director
About The Position
The Global Development Scientist, Director leads clinical and scientific strategy for global hematology trials, shaping clinical evidence that advances therapies from hypothesis through registration. The role works within a global, cross-functional team and supports programs spanning immuno-oncology, tumor drivers and resistance, DNA damage response, antibody-drug conjugates, cell therapy, and epigenetic approaches. It translates strategy into studies, accelerates assets across early and late development, and contributes to defining standards of care. The position provides scientific leadership for clinical protocols and plans, including pivotal studies, and translates complex clinical data into conclusions for regulators and the medical community. It partners with clinical, operations, quality, regulatory, and external stakeholders to plan and deliver trials, support global submissions, and maintain ethical and compliant research. The role is expected to work in the office an average of at least three days per week, with flexibility.
Requirements
- Bachelor of Science degree required.
- Minimum of 5 years of relevant experience.
- Experience in drug development in industry or academia required.
- Sufficient technical knowledge to interact confidently with internal and external partners.
- Foundational knowledge of FDA and other major-country regulations, and detailed knowledge of Good Clinical Practice and other regulations governing clinical research.
- General knowledge of medical monitoring, regulatory approval processes in relevant countries, pharmaceutical industry and R&D operations, and marketing and commercial fundamentals.
- Consistent track record of independently completing and leading peers in components of sophisticated development plans and related documents, methodologies, measures, analytical plans, and evaluation tools.
- Ability to drive or contribute to protocol design, writing, and implementation.
Nice To Haves
- PhD in a scientific field, PharmD, or MD.
- Experience in malignant hematology clinical trials.
- Haemato-oncology background.
- 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 hematologic 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, with strong communication skills that influence diverse stakeholders.
- More than 7–10 years of total clinical development experience.
Responsibilities
- Translate disease strategy and target product profiles into study concepts, protocols, and key study documents with the Clinical Project Team and Global Study Team.
- Provide clinical and scientific leadership and integrity for protocols and clinical plans; own final protocol and governance approvals in alignment with GCP, ICH, and AstraZeneca quality standards.
- Provide clinical and scientific input into early- and late-phase trials, including immunotherapy and cell therapy studies.
- Partner with Clinical Operations to plan, recruit, and deliver trials at pace while ensuring high-quality execution.
- Lead clinical data review and medical data cleaning; synthesize efficacy and safety signals with the Global Development Medical Director; draw conclusions to inform go/no-go decisions and publications; and deliver clinical study reports on time.
- Prepare and contribute clinical content for global submissions, including NDA/BLA submissions, and lifecycle documents such as Investigator’s Brochure, DSUR, PSUR, and regulatory responses.
- Build internal networks across clinical, operations, and quality, and establish effective relationships with regulatory bodies and external service providers.
- Respond to investigational sites regarding ICF changes and protocol questions; plan and deliver investigator meetings and training.
- Lead or contribute to cross-asset or cross-tumor initiatives, evaluate new opportunities and externally sponsored research, and drive portfolio-wide process improvements.
- Work to high ethical standards and comply with internal SOPs, local regulations, and Good Clinical Practice.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
