Associate Global Development Medical Director

The Global Development Associate Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working cross functionally with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. You will work collaboratively on the clinical work underpinning a product.

You will support the development and implementation of late phase AstraZeneca sponsored clinical program strategies, providing clinical input into design & implementation of clinical trials, their delivery, clinical data review, and interpretation of results. This is a meaningful role in the medical monitoring of a clinical study, ensuring that the risk benefit of clinical studies operate to the highest ethical and safety standards, sharing responsibility with Clinical Operations team members in the planning, execution and closure of clinical studies.

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 collaborators 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 enforce to Good Clinical Practice and regulatory requirements.

Responsibilities

• Supports in the evaluation of 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.)
• Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
• Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials), addressing questions regarding scientific and protocol procedures from other study team members and investigative sites.
• Develop relationships with appropriate consultants and key external experts (KEE), study sites, and use these relationships to acquire feedback on protocol design, as well as study training, study execution, and interpretation of study results, and advise recruitment strategies.
• Contributes to the development of medical oversight plan (MOP) and lead the study-level medical monitoring activities accordingly, e.g, monitoring the scientific conduct of the study and safety and efficacy data review and cleaning.
• Member of the GST representing Clinical Development.

Technical Skills

• Drug Development/Clinical Development Planning with the ability to contribute to the planning, and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution.
• Ability to contribute to protocol design, writing and implementation to meet GCP, ICH and all AZ quality standards.
• Understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.
• Organize content and rationales in assigned sections of clinical reports or regulatory/EC/IRB documents (i.e. CTA, briefing book, BLA/NDA).
• Contributes to the preparation and presentation of clinical data and/or selected training sessions to internal/external groups.

Minimum Requirements

• Required M.D or MD./Ph.D. degree or equivalent with at least 3 years of experience in academia or the pharmaceutical industry.
• Clinical training in oncology Industry or academic experience in drug development required.
• Detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
• Experience in Medical Monitoring; Regulatory approval process in relevant countries; pharmaceutical industry/R&D operations; marketing and commercial fundamentals.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.

The annual base pay for this position ranges from $ 177,699 - $266,548 USD Annual. Hourly and salaried non-exempt employees will also b