Global Development Associate Medical Director Ii

3+ years

Not Disclosed

Remote

10 Feb. 16, 2025

Job Description

Job Type: Full Time Education: MD/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Development Associate Medical Director II

Job ID: R-219696
Date Posted: 02/13/2025
Career Level: E

Introduction to Role:

The Global Development Associate Medical Director is an important part of the Clinical Project Team (CPT) and Global Study Team (GST), working cross-functionally in a matrix environment with other CPT, GST, and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. A Global Development Associate Medical Director and a Global Development Scientist may work collaboratively on the clinical work 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 the design and implementation of clinical trials, 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 Associate Medical Director plays a critical role in the medical monitoring of a clinical study, ensuring patient safety. They share responsibility with Clinical Operations team members in the planning, execution, and closure of a clinical study. This role ensures that all clinical studies operate to the highest ethical and safety standards in compliance with FDA, EMEA, ICH, and GCP guidelines, as well as SOPs regarding safety.

The Global Development Associate Medical Director may contribute/assist with functional process improvement initiatives and provide contributions to cross-asset, cross-tumor working groups or cross-therapy areas.

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 adherence to Good Clinical Practice and regulatory requirements.

Accountabilities:

Supports in evaluating the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and comply with FDA, EMEA, ICH, and GCP guidelines as well as SOPs regarding safety.
Works 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 developing 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.
Develops relationships with appropriate consultants, key external experts (KEEs), and study sites to obtain feedback on protocol design, study training, study execution, interpretation of study results, and recruitment strategies.
Contributes to the development of the medical oversight plan (MOP) and leads or contributes to study-level medical monitoring activities, such as monitoring the scientific conduct of the study and reviewing and cleaning safety and efficacy data.
Serves as a member of the GST representing Clinical Development.

Technical Skills:

Drug Development/Clinical Development Planning: Demonstrates the ability to contribute to the planning and timely organization of clinical development components 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 AstraZeneca quality standards.
Demonstrates an understanding of methodology in the design, conduct, review, interpretation, and presentation of clinical research.
Effectively organizes 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.

Essential Skills/Experience:

M.D. or M.D./Ph.D. degree or equivalent is required. Strong preference for individuals with clinical training in oncology.
Industry or academic experience in drug development is required.
Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
General knowledge of:
- Medical monitoring
- Regulatory approval processes in relevant countries
- Pharmaceutical industry/R&D operations
- Marketing and commercial fundamentals
Ability to grow and maintain a high level of expertise in the oncology therapeutic area.

Key Relationships to Reach Solutions:

Internal (to AstraZeneca):

Global Development Scientists
Director Clinical Development & Associate Director Clinical Development
Global Study Team and providers of services to the study team
Clinical Project Team / Global Product Team
Global Clinical Program Leaders
Global Clinical Heads
Medical Science Liaisons (MSLs)
Site Management & Monitoring
Patient Safety
Publications/Communication teams
Other functional leaders (GPL, GPS, GRL, etc.)

External (to AstraZeneca):

External service providers
Investigators and site staff
Key External Experts
Ethics Committees/Institutional Review Boards
Regulatory Authorities

Work Environment:

When we put unexpected teams in the same room, we unleash 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. However, we also value flexibility and respect individual needs.

Join the team at AstraZeneca that is committed to following the science. Driven by curiosity, passion, and determination, we are paving the way to change the practice of medicine in oncology.

Diversity & Inclusion:

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 from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment, recruitment, work authorization, and employment eligibility verification requirements.

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Global Development Associate Medical Director Ii

Job Description

Introduction to Role:

Accountabilities:

Technical Skills:

Essential Skills/Experience:

Key Relationships to Reach Solutions:

Work Environment:

Diversity & Inclusion:

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