Sr./Exec. Director, Biometrics

About Aura:

At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.

We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved. Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including choroidal metastases. Leveraging our VDCs’ broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.

Job Summary:

We are looking to expand our Clinical Development Operations (CDO) team with this newly created position of Senior/Executive Director, Biometrics. You will be responsible for overseeing the design, analysis, and reporting of clinical trial data, ensuring high quality and regulatory compliance. We are looking for people who have the enthusiasm and motivation to be a highly contributing member of a small team.

Reporting to the SVP Clinical Development Operations, the right candidate is responsible for creating and implementing both the near-term and long-term strategic direction for Biostatistics, Statistical Programming, and Clinical Data Management across our therapeutic areas and phases of development while ensuring systems, capabilities, and resources are in place to optimize the design/ conduct and analysis/interpretation of clinical trials and clinical data.

This individual will be a dynamic leader, with proven track record in driving strategic initiatives, fostering cross-functional collaboration, and achieving company goals. Identify and drive implementation of industry data management best practices to ensure timely execution of data deliverables. Bring expertise in implementing robust data governance frameworks, successful team management, and comprehensive understanding of regulatory requirements.

Primary Responsibilities:

• Provide leadership to the team of Aura employees, external contractors, and vendors accountable for statistics, statistical programming, and clinical data management including managing performance, developing people, hiring, and integrating new team members and fostering Aura’s values, mission, and culture.
• Serve as the point of escalation to ensure the timeliness and accuracy of Biometric deliverables.
• Drive development and adherence to Biometric vision, strategy, and operational excellence for global development programs.
• Anticipate new challenges, risks, and needs for the department, and proactively mitigate to ensure business continuity.
• Oversee performance of external vendors responsible for clinical data deliverables to ensure quality completion of all clinical data related deliverables.
• Serve as the strategic partner working closely with other relevant functions to ensure statistical input into strategy, design, and execution of clinical development plans and trial designs.
• Ensure expert statistical input/review/Q.C. to ensure proper statistical methods are applied, data quality meets or exceed industry and company standards, and data interpretation is accurate internally (e.g., clinical studies, programs, regulatory submissions, publications) and externally (e.g., response to health authorities, questions from collaborators/alliance partners, presentations to advisory panels)
• Lead development of new / streamlining procedures and process improvement (e.g., development of statistical standards such as SAPs, outputs; data sharing procedures for internal and external audiences; data QC prior to release) to meet the needs of an evolving Biometrics Department
• Drive development and improvement of department-level standard operating procedures (SOPs)
• Collaborate with partner functions to provide statistical programming, systems analysis, and database management support for important Clinical Development deliverables (e.g., risk-based monitoring and signal-detection)
• Responsible for hiring and allocating Biometrics resources to meet business needs.
• Lead and contribute to clinical data related vendor identification through development and distribution of RFI/RFP and bid defense discussions in collaboration with cross-functional partners.
• Develop in consultation with cross-functional partners clinical data related key performance indicators (KPIs) to support contractual agreements.
• Participate in the development of the clinical components of regulatory submissions and transfer of clinical data as needed, ensure data deliverables meet regulatory submission requirements.
• Ensure all data management activities and processes follow Good Clinical Practice (GCP), relevant regulatory requirements, and SOPs and WIs
• Ensure compliance with Clinical Data Interchange Standards Consortium (CDISC) standards to ensure high data quality standards.
• Responsibly delegate tasks.

Qualifications:

• Master's degree or higher, preferably in a scientific area or health related discipline
• 15 years of experience in pharma/biotech industry, with in-depth knowledge of Data Management and Biostatistics processes
• 5 years of experience in managing a team, including responsibility for projects as well as hiring, managing, mentoring, and/or developing direct reports.
• Strong expertise in clinical data management for Phases I-IV clinical trials and complex study designs in pharma/biotech industry
• Strong working knowledge of Biostatistics processes
• Experience in managing an outsourced data management model.
• Extensive experience with Medidata RAVE and other industry EDC platforms
• Extensive knowledge with GCP, ICH, and FDA and other health authority regulatory requirements as applicable for clinical data management
• Effective team leadership in cross-functional study and program teams
• Excellent ability to manage, motivate, develop, and empower staff.
• Excellent ability to manage competing priorities in a changing environment.
• Superior verbal and written communication and relationship-building skills
• Superior organizational skills
• Familiarity with CDASH and SDTM standards
• Ability to prioritize and multi-task effectively.
• Ability to collaborate, communicate and interact effectively in a fast-paced team environment.
• Strong analytical thinking and problem-solving abilities
• Strong attention to detail

Salary & Benefit Information:

Salary Range: $220,000/yr - $280,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity.)

• Health insurance with FULL premium coverage
• 401K with company match
• Employee Stock Purchase Program (ESPP)
• Competitive Paid time off (PTO)
• Company-paid short & long-term disability insurance and life insurance

Salary : $220,000 - $280,000