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Global Clinical Operations Program Director

Clinical

Gaithersburg, MD, US

Pay Rate Low: 80.00 | Pay Rate High: 90.00

• Added - 12/08/2024

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Our client, an esteemed global biopharmaceutical powerhouse, is actively searching for a experienced Clinical Program Operations Director to join their thriving team.

Summary:

• Lead cross-functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning the resource and managing risk

• Work closely with global study leaders to provide appropriate strategic oversight of a program of studies

• Provide clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, risks and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.

• Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, quality, feasibility, risk)

• On behalf of CPT, responsible for managing clinical plans (cost, FTEs and timelines) in business reporting system, such as PLANIT

• Lead large or complex deliverables and the process to identify and solve/escalate operational issues and drive delivery to plan through internal or external partners (Alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)).

• Act as the point of escalation for study teams for external (e.g. CRO) partners for externally managed/outsourced studies as appropriate

• Responsible for leadership and program management of non-drug project work as assigned, e.g. cross functional improvement/change initiatives

• Provide project leadership & management to cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications (aligning closely with other key contributors to submission package)

• Lead cross-functional teams in delivery of assigned clinical program team (CPT) activities

Qualifications:

• University degree in life science

• At least 8 yrs within pharmaceutical industry or similar large multinational organizations.

• Proven knowledge of project management tools and processes

• Proven experience in clinical development/drug development process in various phases of development and therapy areas.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.