Senior Director, Biometrics What You'll Do As a Senior Director, Biometrics, you will lead our Biometrics organization, translating clinical data into rigorous statistical evidence through leadership of our biostatistics and statistical programming group, driving high-quality deliverables.
• Resource & Delivery Management: Build, oversee and lead delivery of Biometrics programs in line with budgets, operational procedures, regulations, guidelines, and quality standards.
• Regulatory & Compliance: Provide strategic leadership and a clear biometrics voice for Enanta's clinical programs in conjunction with the Clinical Development, Clinical Pharmacology, Clinical Operations and Regulatory; Provide expert input into establishing internal standards, processes and policies for the use of data and the conduct of observational studies.
• Process Excellence: Drive and foster innovation and adoption of emerging technologies/methodologies/approaches within Biometrics in line with long term functional/organizational roadmap and Enanta's SOPs, GCP and ICH guidelines.
• External Partnerships: Engage in strategic communication with executive leadership, cross-functional leadership and external stakeholder networks to optimally influence organizational outcomes.
• Regulatory & Compliance: Act as a key spokesperson and influencer for Enanta's Biometrics at external meetings, including regulatory interactions and scientific meetings; Oversee Biometrics financial planning/forecasting and budget management, timeline development and tracking, and assessing resource needs for respective program(s).
• People Leadership: Lead and mentor Enanta colleagues and contractors. Establish and drive people management processes around performance management, engagement, and development - balancing people aspirations and business needs.
What You Bring • Education & Experience: PhD in statistics/biostatistics with significant experience in biometrics and statistical analysis in biotech/ pharma industry.
• Leadership Experience: Significant experience leading Biometrics activities and managing Biostats and programming teams in a leadership capacity; Significant experience with development of overall department/area strategy, operational management of plans with cross-functional teams, as well as budget planning & management.
• Stakeholder & Partner Management: Experience and demonstrated success in driving high-quality clinical development programs and developing multi- disciplinary high-performing team/s across multiple levels; Significant experience working with senior leadership team and other external audiences (e.g. KOLs, regulatory bodies).
• Regulatory Knowledge: Expert knowledge of Good Clinical Practice (GCP) and regulatory requirements.
What Sets You Apart • Biostatistical Skills: Expert-level capability in biostatistical skills, consistent with the expectations of this role.
• Cross-functional Influence: Expert-level capability in cross-functional influence, consistent with the expectations of this role.
• Document Creation and Management: Expert-level capability in document creation and management, consistent with the expectations of this role.
Pay Transparency Enanta is committed to providing compensation transparency. The expected base salary range for this position is $204,000 to $285,000, based on experience, qualifications, and market conditions. Offers will be determined by several factors, including individual experience and expertise, ensuring both equity and competitiveness.
How to Apply Please complete the application below and include the following attachments:
- Cover Letter
- CV / Resume
- Research Summary (if applicable)
This is a full time position
