Sr. Global Development Medical Director, Breast Cancer Strategy

Gaithersburg, Maryland

Posted in Pharmaceuticals

Job Info

Are you a Medical Director with a passion for clinical drug development, particularly in late stage clinical trials?

Are you looking for an opportunity to make a broad impact on patients lives and outcomes?

Join the team at the heart of AstraZeneca dedicated to Oncology Research and Development, committed to following the science.

About AstraZeneca
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.

Oncology Research & Development, Late Development Oncology
Our ambition is to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Focusing on cutting-edge science with the latest technology to achieve breakthroughs. AZ is a place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes.

Within Late Development Oncology, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. Supportive team players, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges.

What you'll do
The Sr. 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 matrixed environment, with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The Sr. 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 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 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 is 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 SOPs regarding safety. The Senior Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and provide expert contributions to cross asset, cross tumor working groups or cross Therapy Areas, depending on the level of experience.

As a key member of the clinical team, 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. Senior Directors will mentor the development of less experienced members of the clinical team.

Other responsibilities include but are not limited to:
• 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 SOPs regarding safety.
• Work cross functionally within clinical product teams (CPT) to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents (such as Global ICF, CRF, TFL shells, etc).
• Significant contributor to the development of program strategy for assigned compound(s)/programs including scientific contribution to the Target Product Profile and participation in the preparation of clinical development plans.
• 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, inform recruitment strategies and meets the strategic program objectives.
• Responsible for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation.
• Participate or lead as needed the review and assessment of new opportunities and ESRs.
• Accountable for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans
• Responsible for the delivery of final protocol and its governance approval.
• Supports or leads interactions with global medical affairs, marketing companies, commercial, and regulatory functions in collaboration with leadership to ensure cross functional input into protocols.
• In partnership with GCPL, and/or GCH drive work required for technical review of protocols with governance bodies such as DRC and PRC.
• Support the development of clinical components of regulatory submission documents for instances where marketing approval is warranted.
• Lead development and delivery of the clinical study report
• Work cross functionally in the preparation of launch & branding materials and publications.

Essential for the role
• M.D or MD./Ph.D. degree or equivalent. Strong preference for individuals with clinical training in oncology
• Significant Industry or academic experience in drug development required, specifically around submission preparations
• Possesses sound foundational knowledge of FDA and other major country regulations
• Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research
• Possesses strong knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals
• Significant oncology therapeutic experience to be sought out or serve as a resource to other internal/external parties
• Strong leadership skills with the ability to influence others and drive consensus building

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