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Gaithersburg, Maryland, United States
Cambridge, England, United Kingdom
Job reference: R-031008
Posted date: Jun. 28, 2018

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. As Director, Clinical Development Respiratory in Gaithersburg, MD or Cambridge, UK, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

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.

Responsibilities include:

o    Lead Clinical Sub Teams of Product Development Teams.

o    Develop, or supervise development of, Clinical Development Plans for potential products, and present such plans to governing bodies.

o    Develop or supervise development of, trial synopses, protocols and protocol amendments.

o    Be accountable for the ethical and scientific integrity of the plans and studies.

o    Be responsible for the preparation of medical components of Investigator Brochures, ethics, IND and other regulatory communications.

o    Provide medical input to the conduct of clinical trials in a proactive Good Clinical Practice Environment.

o    Provide medical and specialty expertise for safety surveillance, and interact closely with the Safety group to ensure patient safety throughout the entire clinical development process.  Assist with the development of the benefit risk analysis and patient risk management plans.

o    Collaborate with project team members in planning, conducting and evaluating clinical trials.

o    Collaborate with Translational Science to optimise approach to study target inhibition and to understand mechanism of action of products in early clinical development.

o    Oversee planning and management of Investigator meetings, advisory boards and other scientific committees, as required by the protocol (e.g. independent reviews, DSMBs etc.).

o    Interpret trial data to support decision making.

o    Lead development of clinical publications of trial results.

·         Provide clinical input to help evaluate and prioritise new product development opportunities, both internal and external.

·         Provide medical input to preclinical research teams to support optimal development of potential new products.

·         Represent MedImmune to external opinion leaders and at conferences.

·         Develop and manage a network of external experts relevant to the company’s development programmes and seek out competitor intelligence.

·         Serve on internal MedImmune Committees, as requested/required.

·         Attend appropriate scientific meetings to maintain his/her awareness of research activities in his/her area of expertise.

·         Assume other duties as assigned by the Senior Director of Vice President.

Qualifications and Experience

·         MD, board certified (or eligible) in allergy/immunology or pulmonary diseases.

·         Specialty training in respiratory is mandatory.

·         Experience in early (Phase I/II) Clinical Development.

·         Ability to draw on previous clinical research experience to design clinical development plans, to plan and lead studies, to anticipate potential problems and to take appropriate action, with an appropriate level of consultation, in order to meet agreed timelines and costs.

·         Proven leadership skills.

·         Sound knowledge of relevant guidelines and standards.

·         Experience of incorporating translational medicine approach into early clinical development would be a plus.

·         Experience of working with opinion leaders and external consultants.

·         Good working knowledge of ICH GCP requirements and understanding of regulatory requirements.

Personal Attributes

·         Demonstrable evidence of working collaboratively within a matrix team environment.

·         Ability to establish and maintain productive working relationships, both within the organisation and externally.

·         Enthusiastic, adaptable and flexible approach.

·         Proven planning skills.

·         Excellent communication skills at all levels, both internally and externally and across different functions, plus the ability to make effective presentations.

·         Self-motivated and able to motivate others.

·         Ability to lead a team and support other team members.

·         Ability to thrive in an innovative, entrepreneurial environment.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender 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.

Director, Clinical Development Respiratory

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