Process Development Scientist Jobs in Maryland (NOW HIRING)

Hybrid working: Minimum of 3 days per week in the office

Locations: Barcelona, Spain; Gaithersburg, Maryland; Boston, Massachusetts; South San Francisco, California or Manhattan, New York.

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 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 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 clinical 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 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 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.

• 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 a 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.
• 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.

Minimum Qualifications:

• 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 1) medical monitoring; 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) 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

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.