Under the direction of the Global Development Lead, the Associate Clinical Development Lead is responsible, with the project team, for Clinical development support including:
• Responsibility for Medical aspects of assigned studies including medical monitoring
• Provide medical and scientific expertise in the assigned therapeutic area
• Support clinical strategy (CDP) for assigned products
• Drug Safety Assessments in Clinical Programs
• Assists the TA leadership with assessments and intelligence on potential new products and due diligence activities
• Oversight of study design and data generated from Shire sponsored Phase I-IV clinical research programs ensuring that regulatory authority requirements, stakeholder requirements, and quality standards are met.
• Partner with other Shire functions to communicate scientifically accurate information to external stakeholders, meeting appropriate legal and regulatory requirements.
• Acting as a company representative interacting with external scientific leaders and/or Regulatory authorities.
• Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities.
• Primary medical responsibility for clinical study(ies)
• Oversees clinical studies and reviews clinical protocols and clinical study reports for scientific and medical accuracy.
• Develops and demonstrates expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
• Demonstrates the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
• Collaborates with Therapeutic Area leadership (TA Head, Development Team Leads and Clinical Development Leads), Clinical Operations and Medical Affairs to support all development activities for the therapeutic area
• Provides expert Medical advice to assist the project teams for the development of Phase I-IV clinical programs.
• Provides medical and scientific advice within Shire R&D and other functions (e.g. Business Unit Strategy Teams, Commercial Brand Teams) leveraging scientific expertise and providing guidance in support of product launches.
• Interacts as needed with Clinical Development partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
• Leads and/or participates in clinical/medical advisory panels, steering committees and investigator meetings.
• Participates in safety review committees and risk management activities as appropriate.
• Assists in providing medical information support for marketed and developmental projects.
• Participates in drug safety surveillance for Development projects.
• Provides credible company representation in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.
• Supports Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
• Provides input to global publication strategy for the projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals.
• Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
Education & Experience Requirements:
• M.D. degree (required); specialty training and certification (preferred)
• Pharmaceutical Industry experience preferred such as submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, designing and conducting Phase II-III clinical trials
• Specified therapeutic area experience preferred.
Other Job Requirements:
• Availability to travel approximately 25% of time.
• Availability to participate in early or late meetings/teleconferences.
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.
Equal Employment Opportunity
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.
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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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.