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Clinical Program Lead- Combination Products

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POST DATE 9/8/2016
END DATE 2/6/2017

Shire Pharmaceutical Lexington, MA

Lexington, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Description
Under the direction of the Head of Medical Devices, the Clinical Program Lead, Medical Devices will be responsible to serve as the director level device medical representative on assigned project teams, sub teams and corporate initiatives.

The Clinical Program Lead, Medical Devices will have demonstrated ability to manage multiple programs, therapeutic areas and/or work streams with a high degree of complexity; advanced understanding of the device development and execution of clinical program and studies to support novel drug delivery devices and combination products.

In addition will have in-depth knowledge of global regulatory/industry rules and guidance s (e.g. ICH, GCP, promotional guidelines and labeling) to drive the strategic approach to medical device approval and clinical trial application process. The Clinical Program Lead, Medical Devices is responsible for working closely cross-functionally with other global teams including Process Development, Quality Assurance, Global Supply Chain, Drug Safety, Commercial, Legal and Regulatory.

Working with the Clinical Development Head of Devices, Finance and Program Management responsible for budget forecasting and management.

Oversight with an emphasis on strategic planning, implementation and execution program and work stream plans for therapeutic indications or company initiatives in keeping with corporate and department goals.
Assess decisions from other functions and the impact on the program or work stream plan
Provide update and direction to Sr. Management when conflicts, key developments and program scope/direction changes are identified.
Work cross functionally to drive the strategy and collaborate to ensure implementation for device clinical programs or company initiatives
Oversee selection of study sites and vendors
Participate in/or lead cross-functional teams at corporate or global level
Effectively represent the interests and perspective of Global Clinical Affairs

Assess skills and resources needed for success; work closely with internal and external stakeholders to leverage and optimize resources
Review and evaluate resource needs and influence for appropriate prioritization of clinical programs
Provide input and rationale to influence cross-functional team
Ensure performance standards are realistically set and attained for internal and external resources
Align with team members from other functional areas regarding planning, implementation, tracking, analysis and report of milestones

Participate in business development and process improvement activities as needed
Under the direction of the Head of Medical Devices, Global Clinical Affairs, participate in due diligence activities

Other activities as deemed by management
Participate in Research and Development, department and/or corporate wide task forces as appropriate
Provide briefings and deliver technical presentations for top management and customer representatives

Bachelor s degree in life sciences.
Advance degree program a plus however not required.
Minimum 10 years experience in pharmaceutical, device or biotechnology field.
Minimum 3-5 years project management experience in clinical research environment.

Travel up to 20% domestic and international

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.