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Senior Medical Director, Global Clinical Development

AstraZeneca
Gaithersburg, United Statesfull_timeVerifiedPosted 27 Nov 2024
💰 $398,671/yr($265,781/yr$398,671/yr)

About the role

Are you ready to lead the future with an ambitious spirit? As a Senior Medical Director, Global Clinical Development, you will be at the helm of a matrix organization, directing a team of Clinical Scientists working on a late phase vaccine clinical development program. You will be accountable to the VP of Clinical Development, and your leadership will be instrumental in crafting an inclusive culture of growth and development within the V&I business area. Are you up for the challenge?

Accountabilities

  • Providing medical and scientific leadership in the global development of new medicines targeted at indications in the field of infectious diseases 
  • Help design, execute, and interpret clinical trials in one or more development programs (Phase 1 through Phase 3) 
  • Lead the Clinical Team as the Clinical Development Lead and work closely with other colleagues in other internal functions including Patient Safety, Biometrics, Regulatory Affairs, and Clinical Operations 
  • Build strong relationships with a network of external scientific specialists and opinion leaders.
  • Medical oversight to ensure the safety of study participants including review of Adverse Events of Special Interest and Serious Adverse Events and review and writing of safety narrative reports. 
  • Medical oversight responsibilities for medical activities outsourced to third party vendors.
  • Provide expert medical input and write clinical study documents such as protocols and study reports as well as regulatory documents and responses with regulatory authorities.
  • Provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature. 
  • Prepare publications and presentations for scientific meetings and congresses. 

Required Skills/Experience:

  • Experienced physician (MD or MD/PhD) with clinical experience, preferably in pulmonology with expertise in infectious disease. 
  • 10 plus years of experience in clinical drug development, preferably from pharma industry for at least several years, with experience in developing clinical strategy/development plans, authoring of all clinical study document types, management of CROs running clinical trials, authoring of health authority submissions.
  • Good understanding of clinical trials methodology 
  • Experience in the design, execution, and interpretation of clinical studies (e.g., medical monitoring, data cleaning)
  • Proven experience in line management, performance management, capacity management, and budget management.
  • Excellent verbal and written communication skills (including giving presentations) in English.

When we put unexpected teams in the same room, we spark 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 outstanding and daring world.

The annual base pay (or hourly rate of compensation) for this position ranges from $265,781 to $398,671. Hourly and salaried non-exempt employees will also be paid overtime pay whe

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Company

AstraZeneca

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