Shire Global Clinical Development Lead in Lexington, Massachusetts
Provide expert medical advice to the project teams for the development of Phase I-IV development programs. Provide medical input into development of the Target Product Profile (TPP).
Lead/participate as needed in investigator meetings, advisory committee, and scientific meetings. Participate/present at regulatory meetings as needed as Clinical Lead.
Responsibilities will include design and supervision of Shire sponsored clinical trials and medical interpretation of data analyses. Review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific and medical accuracy. Responsibilities may include post marketing commitments and life cycle management initiatives.
Co-lead product safety review committees (SRT) as appropriate.
Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
Preparation of clinical documents including sections for submission to regulatory authorities (meeting packages, Investigational Drug Applications (IND/CTA), NDAs, clinical components of other regulatory packages).
Contribute to scientific publications, provide consultation on medical subjects to investigators and other company personnel, establish rapport with site personnel, external authors and key opinion leaders and searching and analyzing medical literature.
Remain up to date with current information on pharmaceutical regulations, guidelines and practices and therapeutic area knowledge.
Design, author, and implement clinical development plans; contribute to preparation of product and therapeutic area related strategy documents.
Represent clinical development in due diligence and other assessments of external opportunities.
Education & Experience Requirements
MD required with at least 5 years experience in Clinical Research in the pharmaceutical/biotech industry (design and conduct of Phase II-III clinical trials and/or significant late-stage development research expertise). Experience in Immunology or Allergy is required. Prior experience with interacting with representatives of the FDA and other regulatory agencies is also required.
Key Skills and Competencies .
Ability to work cooperatively within a cross-functional team setting is critical as are good interpersonal communication skills. They must be able to effectively lead a cross-functional team in a matrix organizational structure. High analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. The ideal candidate must be capable of identifying, analyzing and adjusting work procedures for maximum efficiency and be able to meet tight deadlines. The candidate will have knowledge of effective clinical development strategies and a good understanding of clinical product development in the pharmaceutical industry.
Domestic and international travel (up to 20%) is required.
Availability to participate in early or late meetings/teleconferences if required.
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Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire 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 is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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.