The Director, Clinical Science will have responsibility for the delivery of scientific solutions and services on assigned projects, along with direct supervision of a team of Clinical Scientists to provide oversight and mentoring and to ensure optimal performance. Through their scientific expertise on project delivery, the Director is responsible for providing strategic scientific insight to external clients and for coaching and mentoring internal teams to drive business success. This includes attendance at strategy meetings and active participation in client-facing interactions to secure full representation of Clinical Science to ensure the scientific and operational success of all WCG MA-PP projects.
The role of Director, Clinical Science requires a high level of expertise in MA-PP scientific solutions and delivery methods and platforms to serve as point-of-reference (internal and external) for assisting with project delivery challenges and for solving problems. This calls for a strategic mindset, deep understanding of processes, along with the ability to be a proficient communicator and leader.
Graduate degree in a life science discipline or other field relevant to the MedAvante-ProPhase business focus is required.
Seven years of experience in the clinical research industry required; experience working for a biopharmaceutical sponsor or a clinical research organization preferred.
Minimum 5 years of experience as a Clinical Scientist, clinical trial science lead or similar role, with external-facing responsibilities managing the clinical aspects of a clinical trials, with demonstrated ability to leverage scientific concepts to influence external audiences and/or clients required.
Minimum 4 years of experience with the administration of rating scales with practical knowledge of study endpoints as part of sponsored clinical research required.
Strong communication and negotiation skills across audiences, demonstrated by ability to assess complex situations, devise impact-generating solutions based on incomplete data and the ability to present complex information in a simplified way is required.
Demonstrated leadership skills and ability to integrate in a team, motivate others and communicate clearly and effectively.
Strong problem solving/decision making skills demonstrated by ability for independent critical thinking, solution generation and engagement in active scientific exchange.
Solid understanding of intermediate research methods and statistics; having research publications strongly preferred.
Expert knowledge of Good Clinical Practice (GCP).
Fluent in English required; bi-lingual or multi-lingual skills are preferred.
Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and the ability to produce detailed reports and presentations using these tools.
Provides expert support and mentoring for a team of clinical scientists by demonstrating advanced experience with all service offerings and by leveraging strong communication skills and operational expertise.
Oversees the timely and quality execution of all study deliverables by a team of Clinical Scientists.
Clinical designee for escalation issues that impact programs assigned to direct reports.
Collaborates with functional team leads to ensure the proper service execution.
Provides expert support for all advanced solutions, leveraging strong communication and negotiation skills and strategies. This includes, but is not limited to, advanced analytics; independent review/rating analysis and remediations, etc.
Own scientific responsibility on assigned projects, along with supervising the assigned team's projects to ensure the scientific integrity, proper escalation and remediation of project-specific challenges are executed and effectively communicated.
Ensure clinical quality standards are met by monitoring team level performance across studies and resolve clinical quality or training related issues.
Responsible for the calibration of clinical team, conducting rater training events, and remediations as specified in the study-specific training plans.
Proactively identify and address project related risks through active communication across departments and adherence to policy/procedure. Resolve and communicate quality events promptly and effectively.
Actively participate in research and publications efforts and report research results externally through peer-reviewed journals, conferences, or other appropriate venues is required.
Identify the need for and contribute to the development of departmental and cross-disciplinary work instructions, process guidelines and standard operating procedures to ensure all processes and procedures meet SOP/GCP requirements.
Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
Attendance and punctuality are essential functions of the position.
SUPERVISORY RESPONSIBILITIES:The position may require the individual to be responsible for the management, direction, coordination, performance, and evaluation of an assigned team and staff. Responsibilities may include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
TRAVEL REQUIREMENTS:This role may require up 20% travel which may be domestic or international, including overnight and weekend stays, consistent with project needs and office location.