Please note that this position can be filled at either the Assoicate Director level or the Director level.
* Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems, and final reports.
* Analyze and synthesize clinical data for publication, US and international regulatory filings.
* Supervise project team members in planning, conducting and evaluating clinical trials.
* Serve as medical monitor with significant responsibility for safety surveillance.
* Key role in designing clinical development plans for assigned project.
* Collaborate with R&D and other senior management in assessing requirements for emerging products, including next generation candidates.
* Collaborate with Marketing and Sales to design research to have maximum marketplace credibility and enhance marketing efforts.
* Identify, select and train clinical research centers and investigators.
* Communicate internally and externally (oral and written communication) on clinical trial design and results.
* Oversees planning and management of investigator meetings, advisory boards and other scientific committees as required by the protocol (e.g. independent reviews, DSMB's, etc.).
* 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 either execute recovery plan (or seek advice depending on strategic impact to company).
* 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 medical safety data is required on daily basis. Must manage multiple tasks/programs with competing deadlines/priorities.
Education & Experience:
* M.D. degree or equivalent medical school degree, board certified (or eligible) preferred in allergy/immunology or pulmonary diseases. Relevant clinical experience within a pharmaceutical or CRO environment is preferred.
In addition we require the following:
* Experience in planning and executing clinical trials is required.
* Clinical research experience in a pharmaceutical or CRO environment a plus.
* Experience interacting with FDA, EMEA, and other NRAs desirable.
* Experience conducting GCP compliant trials ex-US desirable.
* Clinical research experience in respiratory diseases a plus.
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
My company shares my passion for helping to improve human health around the world.
This is My MedImmune
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.