| Job Description | Description
Elan Pharmaceuticals, Inc., a neuroscience-focused biotechnology company, is conducting a search for this position which is located at its new office in Cambridge, MA.
Elan, which is headquartered in Dublin, Ireland, is committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world.
Primary Objective of Position: Oversees pre-clinical and clinical operations and related services. Includes establishing and maintaining the optimal infrastructure to support and advance novel, cutting-edge clinical trials.
Major Duties and Responsibilities:
This leadership position is responsible for developing the infrastructure to support advanced clinical trials. Experienced in industry with expertise in the areas of clinical operations development and strategic planning; experienced with early to late stage clinical trials, and with IND to NDA process. Able to manage clinical operations for a product from pre-clinical through all clinical phases and product launch. Selects, develops and appropriately leads/manages personnel to ensure the efficient operation of the function, and is adept with working with and managing CRO partners and preferred vendors for services and capabilities. Works closely with Regulatory colleagues to assure all global applications occur in a timely and effective manner. Consistently works with abstract ideas or situations across functional areas of the business. Requires in-depth knowledge of the functional area, business strategies and the company’s goals.
Position/Education Requirements:
Skills and Abilities:
10 to 15 years of experience in clinical operations. Familiar with a variety of relevant concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others. A wide degree of creativity and latitude is expected.
Proven track record to deliver key study deliverables in support of operational milestones. Demonstrates good understanding of ICH/GCP, and US FDA regulations as applied to clinical research. Global trial experience will be expected, prior experience in this area beneficial. Detail oriented with excellent organizational skills. Ability to prioritize and multi-task while remaining calm and sensitive to confidential/personal nature of material. Ability to interpret instructions and information under pressure and respond accordingly, with minimal supervision as appropriate.
Excellent interpersonal and communication skills are required. Experience with working in a global environment preferred.
Experience working across global geographies and has the ability to lead across multi-functions.
Experience and demonstrated successful results working in a fast-paced environment managing multiple priorities.
Must have demonstrated leadership in managing people, preferred vendors, resources and budget. Experience with being part of a Development team or company that has had a successful drug development launch(es).
Requires a Bachelor’s Degree, Sciences related field
Masters in Physiology or PhD in Neuroscience very desirable |
| | Company | | Elan | Job Code | | State or Province | | Massachusetts | | |
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