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Senior Medical Director – Hematology Oncology R&D

Posted date Mar. 20, 2025
Contract type Full time
Job ID R-222497
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Why choose AstraZeneca Spain?

AstraZeneca Spain is a rising force in our global business. With headquarters in Madrid and our global hub in Barcelona, we’ve become an important international centre of excellence in the fight against critical disease. Boasting vibrant universities and business schools, the Barcelona ecosystem is a place where scientists can thrive. We attract a diverse workforce from across the globe, shining a beacon for innovation in a country that’s committed to clinical development.

We invite you to bring your talents to Barcelona where our respiratory medicine R&D and Global Marketing centre offers opportunities in R&D, IT, Commercial and HR. Or join us in Madrid and shape our growth in our BUs (Respiratory, Oncology & CVRM ), and a range of Corporate functions. Additionally, you can find sales roles throughout the country. Together, we’re contributing to a world-leading pipeline of therapeutics and delivering life-changing medicines to patients.

Who do we look for?

Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca Spain, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. Alongside technical expertise, colleagues have the resilience, energy and collaborative mindset to change lanes, work with different teams and start projects from scratch.

Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Madrid or Barcelona, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.

Success Profile

Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.

Diverse collaborators

This is a speak-up culture that values collaboration. You’ll proactively bring your unique perspectives, experiences and skills to the table and seek the same from others. With our international team composition and the need for fast-paced collaboration, you’ll always be building new connections with colleagues.

Cutting-edge innovators

When you join us, you’ll be part of a team that embraces digital technology and data to transform the way we work and the work we do. Every day, you’ll help make history, empowered to ignite your creativity and build something enduring.

Resilient trailblazers

Here, the answers aren’t always available. So, you’ll need to bring a fearless, self-starter mindset to navigate uncharted territories. You’ll harness your ceaseless energy to discover and make the necessary connections with colleagues to shape the future and achieve maximum impact.

Agile movers

Seize ownership and excel with autonomy to enjoy the constant rush of ground-breaking discovery. Your ability to anticipate sudden shifts and adapt swiftly will prove critical as you make your mark in an environment that rewards initiative and resilience.

Responsibilities

Job ID R-222497 Date posted 03/20/2025
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies.

AstraZeneca has a multifaceted environment that cultivates collaboration and innovation. We attract top minds, and we nurture and build talent.

Within Hematology R&D, we are committed to advancing the science to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy and Epigenetics) to help address unmet clinical needs in a host of hematological cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death. This unit has responsibility for the value chain from discovery through to late-stage development, enabling rapid acceleration of promising early-stage assets and life-cycle management programs

The Senior Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.   The Senior Global Development Medical Director and counterpart Global Development Scientist work collaboratively in the clinical aspects underpinning a product.  Accountabilities include clinical support for the development and implementation of early and/or late phase AstraZeneca sponsored clinical program strategies, including providing scientific input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to (s)NDA/(s)BLA). 

The Senior Global Development Medical Director plays a critical role in the medical monitoring of a clinical study ensuring safety to patients. They share responsibility with Clinical Operations team members in the planning, execution and closure of a clinical study. The Senior Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset, cross-indication working groups depending on the level of experience.

This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca.  The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.

Depending upon experience level, the role will mentor the development of less experienced members of the clinical team, and may involve direct line management of other physicians or scientists.

  • Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as AZ SOPs regarding safety

  • Work cross-functionally and lead all aspects of the design and implementation of clinical hemato-oncology projects, as leader of our Clinical Product Team (CPT) and member of the Clinical Sub-Team (CST). Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.

  • Significant contributor to the development of program strategy for assigned compound(s)/programs and work with GPT/CPT members to develop a compelling business case for governance approval

  • Provide expert clinical input to influence the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets the strategic program objectives.

  • Participate or lead as needed the review and assessment of new opportunities and ESRs.

  • Accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.

  • Provides expert input into/lead the development of the protocol and related documents and the development and delivery of the clinical study report

  • Full responsibility for the planning, implementation and daily operation of assigned drug development projects in hemato-oncology.

  • Supports or leads interactions with global medical affairs, marketing companies, commercial, in collaboration with GCH/GCPL to ensure cross functional input into protocols.

  • Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests. Contribute to development and delivery of face to face or virtual investigator and monitor training.

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

  • Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development.

  • Present and defend protocols and clinical development plans at internal governance forums.

  • Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II or Phase III studies, innovating the process from protocol development thorough individual study report and coordinated regulatory documentation.

  • Prepare various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).

  • Implement clinical R&D policies, SOPs and related directives.

  • Review potential in-licensing candidates and present recommendations to Senior Management groups.

  • Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.

  • Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.

  • Serve as mentor of less experienced staff that may include physicians or scientists

Minimum Requirements:

  • MD or international equivalent is required

  • Medical hemato-oncology clinical training is required

  • Minimum of 4 years of relevant experience

  • Board Certification is preferred

  • Significant clinical research experience (in industry, academic or CRO environment) related to drug development, design and/or conduct of clinical studies in oncology and/or malignant hematology is required.

  • Possesses detailed knowledge of Good Clinical Practice (GCP) and 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 proven ability to both independently complete, and lead peers in completion in components of complex plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools.

  • Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally

Working at AstraZeneca

Here you’ll have the chance to create a substantial difference to patients’ lives! With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem.

Next Steps? Apply now!

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.

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.

10001001 G CDPN R&D Oncology

Reasons to Join

Thomas Mathisen

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Sales Representative Oslo, Norway

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Christine Recchio

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Sales Representative California, United States

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Stephanie Ling

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

Sales Representative Petaling Jaya, Malaysia

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

What we offer

We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, inclusivity, balance and sustainability. Discover what a career at AstraZeneca could mean for you.

An award-winning company

We're passionate about being a great place to work, and 84% of our employees would recommend us as an employer. We've been recognised as a Top Employer in Spain, an EFR Family Responsible Business, and we achieved third place in Forbes Spain's Top 50 Best Places to Work list.

Inclusive environment

Diversity and inclusion are embedded in everything we do, and our different views, experiences and strengths enrich our culture. There's no salary gap at AstraZeneca, and the number of female employees has increased by four per cent over the last three years. We've also made all positions fully accessible.

Work-life balance

Your wellbeing means a lot to us, and we're here to support you through all of life's ups and downs. That's why we offer an unpaid leave policy, annual leave, reduced-hours timetables and a host of benefits, including a retirement plan, long service award, and health and travel insurance.

Sustainability initiatives

We're committed to harnessing the power of science to become a more sustainable business. We've reduced our carbon footprint by over 9,000 kg of CO2 over the last two years, and we lead the European GoGreen Project, which aims to introduce environmentally friendly options in our fleet of corporate vehicles.

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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.