Senior Director, Clinical Development

4 days ago

Dublin Pike, Ireland AstraZeneca Full time

Overview You will be responsible for:

Representing Clinical Development on the Global Program Team (GPT) and Global Medicine Team in presentations at management and review committees (e.g., Clinical Document Review Committee Development and Commercial Steering Committee).

Fostering development of Medical Directors and CDS and/or fellows.

Leading 2 programs and the preparation and execution of a clinical development strategy and related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents.

Providing scientific and medical input (consultative services) to other R&D, commercial, translational, medicine and business development functions and leads or oversees clinical activities to support due diligences.

Working internally with other members of the CDP to drive program strategy and CDPs.

Coordinate communications and planning between medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical Science) as it relates to clinical development study design, execution and interpretation of results. Serves as the medical authority on the global product labeling team. Driving awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.

Working as part of a cross-functional team with colleagues from biostatistics, data management, clinical pharmacology, commercial, regulatory and project management.

You will need to have
M.D. or equivalent

7+ years of experience (or academic or practice equivalent) in clinical development and/or clinical research and/or global regulatory, and/or product development expertise

We would prefer for you to have
Specialty and/or practice in Cardiology, Metabolic Diseases and/or Amyloidosis

PhD in related subject area

Academic appointment(s)

Publications (peer reviewed) and presentations record

Professional guidelines authorship or working group participation

Familiarity (language skills would be a plus) with Asian (Japan and/or China) Medical Community and regulatory agencies

5+ years of Industry experience

Experience preparing documents and attended regulatory meetings with regulatory agencies

Experience designing and completing multinational clinical trials

History of leading cross-functional teams to define clinical strategy and clinical study design

Experience supporting business development activities

The duties of this role are generally conducted in an office environment. As is typical of an office based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

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