BRIEF COMPANY PROFILE

THE POSITION

POSITION PROFILE

• Leading the biometrics organization by providing a clear purpose and direction.
• Developing and managing biometrics strategy, processes, prioritizations and resource models/allocation that enable Client to deliver on its pipeline in an efficient and innovative manner.
• Recruiting, developing, engaging and motivating the team.
• Providing expertise and guidance in clinical study design while implementing efficient and effective practices in the execution and analysis of clinical trials.
• Representing Client in meetings with regulatory agencies including providing justification and rationale for clinical trial design and statistical methods.
• Driving Biometrics outsourcing processes to ensure strong vendor oversight, accountability and performance.
• Managing relationships with collaborators and biometrics vendors, e.g., CRO’s.
• Leading the development and application of new statistical methodology in support of research and development and keeping abreast of regulatory guidance and requirements in the global environment.
• Ensuring successful study designs and development plans that incorporate forward-thinking statistical strategies.
• Communicating effectively with internal team members, senior and executive management, key opinion leaders and regulatory authorities.
• Enabling efficient data management and statistical programming methodologies.
• Working closely with R&D cross-functional teams to execute effectively on R&D priorities and programs, ensuring timely and successful completion of projects.

• Delivering excellence in the Biometrics execution on projects in support of Client’s overall R&D strategy.
• Effectively ensuring appropriate progress in Biometrics activities and deliverables – hereunder meeting project timelines. 
• Facilitating seamless collaboration between Biometrics team members and key internal stakeholders in e.g., Clinical Operations, Medical & Science, Safety, Medical Writing, RA, QA and others.
• Ability to successfully alternate between the managerial aspects of the job and exercising operational skillset in e.g., statistics.
• Ensuring effective management of CRO’s and other key vendors/partners.
• Engaging on Development Management Team as a strategic contributor.

CANDIDATE PROFILE

• 10+ years of biotech/pharmaceutical experience and with a comprehensive understanding of the R&D drug development lifecycle.
• Demonstrated understanding of the clinical development process and interdependencies.
• Comprehensive knowledge of statistical methodology with demonstrated ability of applying advanced methods in clinical trial design and analysis.
• Proven track record of BLA/NDA/MAA experience including significant roles in regulatory interactions and advisory committee hearings.
• Demonstrated experience in managing CRO’s effectively and holding them accountable.
• Demonstrated ability to develop and nurture established teams - preferably with strong people management or matrix leadership experience

Solution oriented; Plans actions to secure optimal use of time and resources, compares achieved results to set objectives, follows up on delegated tasks and decisions.