Clinical Development Program Leader - 1382634_46528583812_12-4658

at Beacon Hill Staffing Group in Springfield, Illinois, United States

Job Description

• Develops the TPP and the Clinical Development strategy as a member of the Core Team and with input from the CDP team
  * Coordinates alignment and agreement on CDP matters with the CDP Team, Core Team and GCD-LT
  * Ensures that the design of each clinical study is consistent with the CDP
  * Ensures that the CDP is in line with the approval path agreed with Regulatory Agencies and with the agreed business plan & objectives
  * Provides clinical approval (protocols, CSRs, lay summaries, clinical trial disclosure &/or deferral strategy, data sharing requests)
  * As part of the Submission Team, prepare/review Briefing Books, eCTD modules, represent clinical aspects during interaction with Regulatory Authorities
  * Regularly updates the CDP team all aspects discussed at Core Team or internal bodies
  * Secures necessary internal approvals & external endorsement (e.g. disease area experts, consultants) to the CDP elements
  * Ensuring accurate & timely documentation of all actions and decisions related to the CDP.

• Required experience/background: A significant experience in designing and executing a comprehensive clinical research & development plan. At least 5 years in an R&D role in the pharmaceutical/biotech industry, or 7-10 yrs in academia with clinical investigator track record. Experience within the specific therapeutic area is a plus.
• Technical skills: Fluent written and verbal communication skills in English. Ability to interact with academic and regulatory experts with confidence, integrity and persuasion. Strong business acumen, able to see the big picture and to weigh pros and cons and drive towards an informed decision. Strong ability in analysing and interpreting complex data sets.
• Managerial skills: Leading a cross-functional team, working in a matrix environment, problem-solving, motivating team members and providing a safe environment for the expression and exchange of innovative thoughts and ideas. Courage to take initiative and to learn from failures and setbacks. Excellent communication with peers, stake holders, Sr. managers, and teammates
• Pharmaceutical industry / Clinical Investigator experience: 7-10yrs for CPL
• Proficiency in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance
• Demonstrated proficiency in Written, Verbal and Face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global), and government agencies.
• Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail while responding to rapidly changing priorities and aggressive deadlines.
• Proficient in MS Office (Word, Excel, Project), Adobe and Outlook.

• Medical Doctor Degree; Respiratory Diseases/Pulmonology experience required