MedImmune Associate Director Clinical Development Respiratory in Gaithersburg, Maryland

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.

We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Position Summary:

Major Duties and Responsibilities:

  • Key role in design, implementation and execution of clinical studies:

  • Establish and approve scientific methods for design and implementation of clinical study protocols (CSP), data collection systems and final reports.

  • Ability to analyze, synthesize and interpret clinical data in both ongoing and completed studies for safety surveillance (acting as medical monitor where applicable) and publications.

  • Identify, select and train clinical research centers and investigators.

  • Overseas planning and management of investigator meetings, advisory boards and other scientific committees as required by the CSP (e.g. independent reviews, DSMBs etc.).

  • Collaboration with:

  • Project team members in all elements of clinical studies including regulatory, translational and research colleagues

  • R&D and other senior management in assessing requirements for emerging products, including next generation candidates

  • Commercial to design research to have maximum marketplace credibility and enhance marketing efforts.

  • Communication:

  • Both internal and external (oral and written communication) on clinical development plans, clinical study designs and results.

  • Additional responsibilities:

  • Contribute to key department and company initiatives as applicable to role, skills and experience.

Requirements/Qualifications:

Education

PhD (preferably respiratory or allergy) with industry experience or M.D. degree or equivalent, ideally board certified (or eligible) preferred in pulmonary medicine or allergy.

Experience:

Clinical study conduct in a pharmaceutical, CRO or healthcare environment.

Special Skills/Abilities:

Must be an excellent communicator with proven leadership skills and the ability to interact collaboratively in a cross functional environment.

Job Complexity:

High; must integrate and analyze non-clinical and clinical data as well as data/input from multiple internal and external functional areas. Synthesis of previous clinical data and ongoing deadlines/priorities.

Supervision:

Role is that of individual contributor. Must be able to operate independently in medical, safety and clinical development tasks with minimal supervision. Once direction is provided, must identify problems, generate solutions (or options) and follow agreed plans through to conclusion.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.