Vice President, Clinical Development

AstraZeneca GmbH
Gaithersburg, MD
Mar 14, 2018
Mar 15, 2018
Full Time
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. As a VP, Clinical Development in Gaithersburg, MD you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives., Our North America Commercial Headquarters are in Wilmington, DE, and one of our three core global R&D centers is in Gaithersburg, MD. Gaithersburg is also home to MedImmune, the global biologics research and development arm of AstraZeneca. We have a number of other R&D, manufacturing and office locations across the country.The Clinical VP reports to the EVP and Head of MedImmune and is a global position with broad responsibilities of major significance to the success of assets in the MedImmune CVMD, ID/Vaccines, and Respiratory portfolios. The VP will provide strategic vision and leadership for the therapeutic areas (TAs) and will be accountable for all clinical drug development programs from First-time-in-human (Phase 1) through clinical Proof-of-Concept (Phase 2B). The Clinical VP will lead and develop a group of experienced physicians, clinical scientists, and clinical operations staff directly responsible for projects in the various portfolios. The company is a matrixed environment and the position requires that the individual establish and maintain strong relationships with senior stakeholders across MedImmune and AstraZeneca Major Responsibilities: Accountable for all early clinical development plans and clinical trials within the designated TAs; chairing the Clinical Functional Review Committee (FRC) and Protocol Review Committee (PRC), respectively; rotating member of the MedImmune Safety Review Board (MSRB) Accountable for the operational execution of clinical trials to meet department goals, including all associated clinical documents (eg protocols, informed consents, clinical study reports, etc), clinical sections of regulatory documents (eg IND, annual updates, investigational brochures, Agency briefing packages, etc), registration of clinical trials (eg and posting summary results, enrollment of patients, managing DSMBs and Advisory boards; May need to take on direct project responsibilities for one or more assets depending on the stage of the portfolio and resources available Review and interpret study results for strategic decisions, publication, and international regulatory filings. Communicate internally and externally on clinical trial design and results Collaborate with cross-functional TA leaders within MedImmune and TA counterparts within the late-stage organization at AZ; provide clinical leadership for projects within the general therapy areas (eg Investigative Medicines Development Unit - iMED) and establishing a strong partnership with the iMED heads for the TAs and the heads of the designated TAs in late-stage development at AstraZeneca Accountable for securing and maintaining appropriate resources to achieve the department's goals Supporting, or assigning support, for business development activities, including due diligence Will be required to travel roughly 10% - 20% of the timeQualified Physician (MD degree or equivalent), or MD/Ph.D., and 10 years of industry experience Clinical drug development experience or well-established clinical professional with strong therapeutic knowledge one or more of the designated TAs Board certified (or eligible) preferred in at least one of the TAs Experience: Recognized expert within the early Clinical Development setting Experience within one of the designated TAs essential with knowledge in the other TAs a plus. Clinical development expertise gained in a variety of disease areas advantageous. Experience in designing and conducting GCP compliant trials is essential Experience of Translational Science and understanding of the requirements for transition of a new drug from pre-clinical to clinical development is essential for this role since it will focus on the early clinical development of a number of assets All activities within Phase I & Phase II required Experience with the clinical development of biologic agents desirable Independently able to manage people and teams Excellent communicator with proven leadership skills and the ability to collaborate/influence in a cross-functional matrixed environment Agile and comfortable with change; ability to deal with ambiguity when it exists Strong ability to integrate and analyze non-clinical and clinical data as well as data/input from multiple internal and external functional areas Takes accountability for medical and safety issues in patients Ability to identify problems, generate solutions (or options) and execute recovery plan (or seek advice depending on strategic impact to company)