Clinical Program Lead

Purpose

The CPL is a permanent member of the cross-functional R&D global Core Team who plays a key role in defining the target disease profile, target product profile, and the development and life cycle strategies of a given project. The CPL leads the Clinical Development Plan (CDP) Team (which consists of functional leaders from within GCD e.g.: Clin Pharm, Clin Ops, Biostat, etc.) in the design and execution of the clinical development pan (CDP) from Phase I-IV world-wide. The CPL is the senior Clinical Signatory on all clinical documents related to his/her project such as phase I-IV study protocols, the Investigator’s Brochure, the Risk Assessment & Mitigation Plan, publications, and is responsible for all clinical aspects related to the Clinical Trial Dossier (clinical modules, briefing books, scientific advice, meetings with regulatory agencies, etc.) and is the main clinical contact with external though leaders, professional societies and patient advocacy groups. The CPL serves as the principal internal clinical resource for R&D concerning the disease area and project, working with other members of the Core Team to raise disease awareness and product knowledge levels.

Main Responsibilities

• 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, Client 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.

• Experience RequiredRequired 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 analyzing 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: 3 Years for CRP and 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.

Education

• Medical Doctor Degree; certification in Respiratory Diseases/Pulmonology will represent a plus