Join us on our exciting journey! COMPANY™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, COMPANY offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
• Elaborate integrative product development strategies for pharmaceutical products (drugs, biologics, devices) focusing on clinical-commercial convergence that encompasses all phases of development from discovery to market, including preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy.
• Assess risk and probability of success for candidate pharmaceutical products, including preparation of a gap analysis, where appropriate
• Oversee the innovative development of compounds to ensure regulatory and commercial success.
• Prepare or provide strategic guidance for clinical development plans as required in compliance with applicable regulatory, medical and ethics guidelines.
• Ensure high-quality, well-reasoned, objective deliverables (using data-driven design, where available and appropriate) that meet the highest standards of medical, ethical and scientific integrity and conduct.
• Propose, defend, and monitor budget requirements for product development programs.
• Propose strategies to manage and accelerate timelines for drug development strategies.
• Propose, defend and lead team members to the successful application of strategies.
• Identify, promote, and develop innovation in pharmaceutical product development.
• Assume the role of customer senior management as requested, leading customer or virtual cross functional drug development teams.
• Provide drug development expertise to support strategic business activities and investment opportunities.
• Assist in the development of programs to maximize the organization’s growth and profitability.
• Ensure Customer Satisfaction by working closely with Senior Management, CRO Operations, Therapeutic Units, and other Operations Heads to ensure optimum strategic consultancy to customers.
• Serve as a key resource and participate in strategic business development activities including presentations to prospective clients, professional meetings or other business development activities for COMPANY Strategic Drug Development.
• Provide internal and external therapeutic and pharmaceutical development-related educational services in support of all branches of COMPANY business.
• Attend key scientific meetings/conferences and keep abreast of relevant scientific publications to maintain awareness of current scientific developments and progress in drug development methodology; As appropriate, represent COMPANY or the partner in such meetings.
• Develop and maintain ongoing relationships with pharmaceutical and biotechnology companies, key opinion leaders; identify new business opportunities.
• Provide due diligence scientific, medical, regulatory, and drug development expertise and activities for COMPANY or COMPANY customers.
• Compliance with all business office requirements for tracking of time and effort.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- · Bachelor's degree in life sciences or related field and 17 years relevant clinical research experience with multi-regional and global focus including 11 years leadership experience (experience managing people desired); or equivalent combination of education, training and experience
- · Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- · Extensive use of keyboard requiring repetitive motion of fingers
- · Regular sitting for extended periods of time
- · May require frequent travel