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About the Role

The Global Development Medical Director plays a critical role in the medical monitoring of clinical studies, ensuring patient safety. This position involves collaborating with cross-functional teams to develop and implement clinical program strategies, review and interpret clinical data, and contribute to regulatory submissions. The role demands strong communication skills and adherence to the highest ethical and regulatory standards.

Responsibilities

Provide clinical support for the development and implementation of early and/or late phase clinical program strategies.
Provide clinical input into the design and implementation of clinical trials.
Oversee the delivery of clinical trials, including clinical data review and interpretation of results.
Ensure timely reporting of trial results for worldwide registration of the product.
Provide clinical input to (s)NDA/(s)BLA submissions.
Perform medical monitoring of clinical studies to ensure patient safety.
Share responsibility with Clinical Operations for the planning, execution, and closure of clinical studies.
Provide expert input or lead functional process improvement initiatives.
Contribute to cross-asset, cross-indication working groups.
Operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws, and Good Clinical Practice.
Ensure the risk-benefit of a clinical study and adherence to ethical and safety standards.
Ensure compliance with FDA, EMEA, ICH, GCP guidelines, and AZ SOPs regarding safety.
Lead all aspects of the design and implementation of clinical hemato-oncology projects.
Ensure the scientific and medical content of all clinical programs is rigorous.
Contribute to the development of program strategy for assigned compound(s)/programs.
Develop a compelling business case for governance approval with GPT/CPT members.
Provide expert clinical input to influence study design through collaboration with investigators, external experts, and stakeholders.
Participate or lead the review and assessment of new opportunities and ESRs.
Ensure the relevance and accuracy of clinical science underpinning clinical studies.
Provide clinical and scientific leadership and integrity for protocols and clinical plans.
Lead the delivery of final protocols and their governance approval.
Lead the development of protocols and related documents.
Lead the development and delivery of clinical study reports.
Take full responsibility for the planning, implementation, and daily operation of assigned drug development projects in hemato-oncology.
Support or lead interactions with global medical affairs, marketing companies, and commercial teams.
Ensure timely responses to investigational study sites for ICF changes, protocol, and EC/IRB questions.
Contribute to the development and delivery of investigator and monitor training.
Support the development of clinical components of regulatory and EC/IRB submission documents.
Prepare clinical development plans integrating pre-clinical and early clinical findings.
Ensure cross-functional alignment throughout early phases of clinical development.
Present and defend protocols and clinical development plans at internal governance forums.
Serve as Medical Monitor, responsible for safety monitoring of clinical trials.
Act as a medical expert for Phase I/II or Phase III studies.
Innovate the process from protocol development through individual study report and coordinated regulatory documentation.
Prepare official and regulatory documents for Regulatory and other agencies (e.g., Dossiers, BLAs, INDs, Safety and Annual reports).
Handle responses to regulatory agencies regarding complex clinical development issues.
Implement clinical R&D policies, SOPs, and related directives.
Contribute to initiatives to improve the quality and content of clinical programs and cross-functional processes.

Requirements

MD or international equivalent is required.
Minimum of 2 years of relevant experience.
Medical hemato-oncology clinical training is required.
Board Certification is preferred.
Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or malignant hematology is preferred.
Possesses general knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
Possesses general knowledge of medical monitoring.
Possesses general knowledge of the Regulatory approval process in relevant countries.
Possesses general knowledge of the pharmaceutical industry/R&D operations.
Possesses general knowledge of marketing and commercial fundamentals.
Good understanding of clinical trials methodology.
Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally.

Skills

Hematology
Oncology
Clinical Development
Protocol Design
Medical Monitoring
Regulatory Submissions
Data Review and Interpretation
Cross-functional Collaboration
Communication
Presentation Skills
Ethical Standards
Good Clinical Practice (GCP)
Risk-Benefit Assessment

Location

South San Francisco, CA

Work Type

Hybrid
Office based minimum 3 days per week

Experience Level

Minimum of 2 years of relevant experience

Education Level

MD or international equivalent

Salary/Compensations

$241,613 to $362,420

Benefits

Short-term incentive bonus opportunity
Eligibility to participate in equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
Qualified retirement program (401(k) plan)
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage

About the Company

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company.
We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases.
We are dedicated to being a Great Place to Work where employees are empowered to push the boundaries of science, challenge convention and unleash their entrepreneurial spirit.
We embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.
There is no better place to make a difference in medicine, patients, and society.
We foster an inclusive culture where diverse thinking generates new and valuable opportunities.
We are committed to lifelong learning, growth, and development for all.
Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients.
Inclusion and diversity are fundamental to our success, as innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
We are curious about science and the advancement of knowledge.
We find creative ways to approach new challenges.
We are driven to make the right choices and be accountable for our actions.
As an organization centered around what makes us human, we put a big focus on people.
We want colleagues to wake up excited about their day at the office, in the field, or in the lab.
Along with our purpose to bring life-changing medicines to people across the globe, we promise to help colleagues realize the full breadth of their potential.
Here, you’ll do work that has the potential to change your life and improve countless others.
Together with your team, you’ll shape a culture that unites and inspires us every day.

Equal Opportunity

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.
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.