Global Development Medical Director, Late Respiratory and Immunology Clinical Development

AstraZeneca • Gaithersburg, MD

9d • Hybrid

About The Position

As a Global Development Medical Director, you will support the clinical project team and assist the Global Clinical Project Leader and Global Clinical Head with the design & interpretation process, establishing clear design objectives for clinical programs and studies. You will provide medical input into the content of core labelling texts and medical support for commercial activities, support for medical monitoring of clinical studies. And, you will also provide medical and scientific expertise as well as tactical and strategic medical input to the development of AstraZeneca’s compounds; primarily from Phase IIb to Phase IV. This includes the design, delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of Respiratory and Immunology products in late-stage development.
In the BioPharmaceuticals Research & Development, Late-stage Development, Respiratory & Immunology function you will work in a truly international working environment, with opportunities to meet and discuss with key external experts, other medical colleagues and experts in basic science, as well as commercial and regulatory functions.
Our therapy area aligned groups of physicians and scientists provide clinical guidance and scientific leadership for clinical development programs within AstraZeneca's global organization.
The Global Development Medical Director will work in a wide range of aspects in pharmaceutical medicine, and due to the global responsibilities, there will be a multitude of contacts with health authorities, colleagues and marketing companies within AstraZeneca. This is an opportunity to take on the challenges of clinical development in a group of positive, focused and highly motivated colleagues.
What you will do:
Be involved in providing medical and scientific leadership in the global development of new medicines targeted at indications in the field of respiratory diseases and wider range of immunological disorders
Have an important role providing medical and scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs.
Build strong relationships with a network of external scientific experts.
Work closely with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations.
Be involved primarily in late stage (Ph2b and later) clinical programs while also collaborating with clinical colleagues supporting Early (R&I) stage programs and medical affairs.
Lead and contribute to medical monitoring of trials
Provide expert medical input into the preparation of regulatory documents and interactions with regulatory authorities.
Provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature.
Develop and review protocols, informed consent, investigator’s brochure and other clinical development documents.
Participate in the preparation of scientific publications and presentations at scientific meetings and congresses.

Requirements

• MD or MD/PhD
• 3+ years of pharmaceutical industry experience OR 3+ years of clinical research experience in the academic or clinical practice setting
• Demonstrated partnership and collaboration skills, including acting as the leader and clearly communicating across countries and cultures
• Fluent in oral and written English, with good presentation skills and effective communication

Nice To Haves

• Pulmonary medicine, Immunology, Rheumatology, Allergy, or Dermatology background is desirable.

Responsibilities

• Be involved in providing medical and scientific leadership in the global development of new medicines targeted at indications in the field of respiratory diseases and wider range of immunological disorders
• Have an important role providing medical and scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs.
• Build strong relationships with a network of external scientific experts.
• Work closely with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations.
• Be involved primarily in late stage (Ph2b and later) clinical programs while also collaborating with clinical colleagues supporting Early (R&I) stage programs and medical affairs.
• Lead and contribute to medical monitoring of trials
• Provide expert medical input into the preparation of regulatory documents and interactions with regulatory authorities.
• Provide expert medical and scientific analysis and interpretation of data from ongoing studies and in the literature.
• Develop and review protocols, informed consent, investigator’s brochure and other clinical development documents.
• Participate in the preparation of scientific publications and presentations at scientific meetings and congresses.

Benefits

• short-term incentive bonus opportunity
• eligibility to participate in our equity-based long-term incentive program
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree