Associate Medical Director, Clinical Development Sciences
Alexion

Job Info

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Job Duties & Responsibilities

• Function as the Medical expert for the clinical study team
• Protocol development from study concept to final protocol
• Oversight of global clinical trial team(s) on assigned program(s)
• Collaborate on, or lead where appropriate, the preparation of clinical study related documents
• Prepare for and coordinate Investigator meeting planning and execution and/or on-site initiation meetings
• Liaise with other functions to enable quality clinical study execution
• Monitor, clean, analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate
• Presentation at academic congresses, investigator meetings and advisory meetings
• Development of medical content for regulatory documents and responses, including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
• Independent data monitoring committee activities
  

Essential Qualifications

• MD
• Previous history executing and overseeing clinical trials
• Safety medical monitoring
• Protocol development experience
• Regulatory experience
• Basic statistical knowledge
• Excellent written / oral communication skills
• Ability to think strategically
• Willingness to take on new responsibilities
• Interest in career progression and ability to take on additional responsibilities

Preferred Qualifications

• Internal Medicine, Cardiology
• History of academic clinical or basic science research
• Publication in peer reviewed journals
• Industry experience a plus but not required

Date Posted
05-Nov-2024

Closing Date
29-Dec-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

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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