• 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 in as needed in investigator meetings, advisory committee meetings. Participate/present at Regulatory meetings as needed as Clinical Lead. • Responsibilities will include design and supervision of Shire sponsored clinical trials, participation in medical interpretation of data analyses, safety reviews. • 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. • Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
Preparation of clinical documents, sections or contribute to 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 • Assist with clinical assessment of new business development opportunities as needed.
Requirements: Minimum Qualifications:
• M.D. or D.O. required, Oncology experiencerequired. • Specialty training with a minimum 5years’ experience working in Clinical Development in the Biotech or Pharmaceutical industry. • Strong collaborative interpersonal and communication skills, ability to problem solve and work in a fast paced environment.
Req ID: R0012784