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Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takedas long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the worlds leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.
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Job ID SR0039354 Date posted 10/04/2019 Location Lexington, Massachusetts
Provide a brief summary describing the major role, responsibilities and purpose of the job. Summarize key areas of accountability and budget responsibility, if applicable.
Under the direction of the Senior Director Medical Devices and Combination Products, the Global Clinical Development Lead (GCDL) Medical Device and Combination Products will be responsible to serve as the device clinical representative on assigned project teams, sub teams and corporate initiatives.
The candidate 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, execution of clinical programs and clinical studies to support novel drug delivery devices and combination products.
In addition will have in-depth knowledge of global regulatory/industry rules and guidances (e.g. ICH, GCP, and labeling) to drive the strategic approach to medical device approval and clinical trial supporting documents development process. The Clinical Program Lead, Medical Devices is responsible for working closely cross-functionally with other global teams including Device Development, Quality Assurance, Clinical Operations, Global Regulatory, Drug Safety, Commercial, and Legal.
50% 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.
40% Assess skills and resources needed for success; work closely with internal and external stakeholders to leverage and optimize resources
5% Participate in business development and process improvement activities as needed
5% Other activities as deemed by management
Education & Experience Requirements
Key Skills and Competencies
Complexity and Problem Solving
Internal and External Contacts
List contacts this job advises, consults and coordinates with on a regular basis. Describe to whom this job is accountable. Indicate each Contact Category (Internal, Vendor, Customer, or Other) and provide examples.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takedas Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, 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-###-#### and let us know the nature of your request and your contact information.
Job ID SR0039354
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Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers.
At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews. And we are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: 2) file a complaint with the U.S. Federal Trade Commission: and/or 3) file a report with your local police department.
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