Associate Medical Director, Clinical Development

This is what you will do:

Seeking a physician with 3-5 years of clinical research or clinical trials experience in industry or equivalent experience in academia or hospital system. The primary role is to work within the Hematology/Nephrology Clinical Development Department. This individual will serve as a medical monitor for the assigned study(ies) which are typically phase 1-4 clinical trials, or other studies as directed by the line management. This position additionally offers substantial opportunities for regulatory and commercial interactions and career advancement in the fast-moving area of rare disease.

You will be responsible for:

• Medical Expert for clinical study team
• Medical Monitor for the assigned trials or studies
• Medical Data Review
• Protocol development from concept to final protocol
• Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring
• Strategic guidance to phase II/III development programs and oversight of global clinical trials/trial team (s) on assigned program(s)
• Presentation at academic congresses, investigator meetings and advisory meetings
• Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
• Particiapte in or lead ad hoc clinical development projects as directed by line management

You will need to have:

• Medical doctor (MD) or foreign equivalent physician education
• History of industry, academic or hospital-based clinical or basic science research
• Excellent written / oral communication skills
• Ability to think strategically
• Attention to detail
• Interest in career progression and taking and willingness to take on new responsibilities
• 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 non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Formal training or education in clinical trials, epidemiologic design, statistical methods and/or quantitative sciences.
• Master degree in clinical research or related field preferred
• 1-2 years of industry experience 
• Previous clinical trial experience as medical monitor in industry setting
  • Safety medical monitoring and reporting experience
  • Protocol development experience
  • Understanding of regulatory requirements related to clinical trials e.g. FDA, EMA, MHRA
• Publication in peer reviewed journals
• Presentation of conference abstracts in international conferences

Date Posted

23-May-2024

Closing Date

28-Jul-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.