US-MA, Global Clinical Development Lead SR0018217-MZ
Job Duties: Reporting to the Global Development Lead, the Global Clinical Development Lead will serve a key role of providing expert medical input to one or potentially more clinical development programs. In collaboration with the global Clinical Operations Lead, (s)he will lead the DOT (Development Operations Team) and coordinate global study activities on the program. Lead development of the Clinical Strategy/Clinical Development Plan (CDP). Provide medical oversight into protocol development, data generation and reporting from Takeda sponsored Phase I-IV clinical development programs ensuring that regulatory requirements and quality standards are met. Will act as a company representative interacting with external scientific leaders and regulatory authorities. Responsibilities 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 Takeda 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 diligences and other assessments of external opportunities. Education & Experience Requirements MD required, preferably with at least 3-5 years experience in Clinical Research in the pharmaceutical/biotech industry (medical oversight and conduct of Phase II-IVclinical trials). Experience in Internal Medicine and/or Pediatrics in combination with knowledge of Immunology or related fields is required. Board eligibility/certification in Allergy/Immunology is preferred. Experience in regulatory agency interactions is preferred.. 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. Other Job Components Decisions on company positions on causality with regard to adverse events during clinical trials, decisions on protocol exemptions, interpretation of clinical data, recommendations to upper management on clinical study design and development strategy. Assessment of external opportunities and competitive landscape within assigned TA including presentation of results/recommendations to management committees. Internal and External Contacts Internal: Development project team members including the program executive and representatives from regulatory affairs, marketing, research, clinical operations, biometrics, medical affairs and, occasionally manufacturing. External: Key academic opinion leaders, representatives of regulatory agencies (such as the FDA and EMEA), CRO employees, clinical investigators. Other Requirements 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, 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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