Global Development Medical Director, Late Oncology
Company: National Black MBA Association
Location: Gaithersburg
Posted on: October 10, 2024
Job Description:
The Global Development Medical Director is an important part of
the Clinical Project Team (CPT) and Global Study Team (GST).
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 trials and their delivery, clinical data
review, interpretation of results, and activities required for
worldwide registration of the product. The role plays a critical
role in the medical monitoring of a clinical study ensuring safety
to patients. You will work collaboratively with the Global
Development Scientists in the clinical aspects underpinning a
product.As a Global Development Medical Director in Late Phase
Oncology R&D you will:
- Be responsible for ensuring the risk-benefit of a clinical
study, ensuring that all clinical studies operate to the highest
ethical and safety standards and in compliance with regulatory
guidelines and contribute to medical review and monitoring
activities.
- Work cross-functionally within clinical product teams to ensure
the clinical strategy is translated into the development of the
study concept document, study protocol, and related documents.
- Develop relationships with appropriate consultants and key
external experts (KEE), study sites, and use these relationships to
obtain feedback on protocol design, as well as study training,
study execution, and interpretation of study results, and inform
recruitment strategies.
- Be responsible for the relevance and accuracy of clinical
science underpinning of clinical study based on detailed scientific
review and consultation.
- Support or lead interactions with global medical affairs,
marketing companies, commercial, and regulatory functions in
collaboration with GCH/GCPL to ensure cross-functional input into
protocols.To be successful, you will need to demonstrate capability
in the following technical areas:Drug Development/Clinical
Development Planning: Demonstrates the ability to undertake the
planning, and timely organization of components of the clinical
development plan and work with other functions to achieve
successful study initiation and execution.Research: Demonstrates
understanding of methodology in the design, conduct, review and
interpretation, and presentation of clinical research and can
conduct literature reviews to inform protocols, and author
background sections on the disease or current medical
therapy.Presentation and Communication: Ability to prepare and
present clinical data, training sessions to internal and external
audiences and to contribute to clinical reports and integrated
summary reports. Ability to clearly communicate scientific
concepts/data to leadership committees (e.g., LSPC, DRC, PRC) or
external groups (e.g., Investigator Meetings, IDMCs, Conferences
Presentations).Required Qualifications:
- Required M.D or MD/Ph.D. degree or equivalent. Strong
preference for individuals with clinical training in oncology.
- 2 years of Industry or academic experience in drug
development.
- 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.
- Ability to grow and maintain a high level of expertise in
oncology therapeutic area.When we put unexpected teams in the same
room, we ignite 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 ambitious world.Why
AstraZeneca?Join the team at the heart of AstraZeneca that is
committed and encouraged to follow the science. Driven by our
curiosity, passion, and determination we are paving the way to
change the practice of medicine in Oncology. As Clinical
Development Physicians and Scientists in 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.Date Posted: 02-Oct-2024Closing Date:
24-Oct-2024Our mission is to build an inclusive and equitable
environment. We want people to feel they belong at AstraZeneca and
Alexion, starting with our recruitment process. We welcome and
consider applications from all qualified candidates, regardless of
characteristics. We offer reasonable adjustments/accommodations to
help all candidates to perform at their best. If you have a need
for any adjustments/accommodations, please complete the section in
the application form. AstraZeneca requires all US employees to be
fully vaccinated for COVID-19 but will consider requests for
reasonable accommodations as required by applicable law.
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Keywords: National Black MBA Association, Frederick , Global Development Medical Director, Late Oncology, Executive , Gaithersburg, Maryland
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