At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What You’ll Do
As the VP, Head of Biometrics, you will provide strategic leadership and oversight for the Biometrics function, which includes Biostatistics, Statistical Programming, and Data Management. You will lead the development, execution, and interpretation of statistical analyses across the company's drug development portfolio. This is a critical leadership role that ensures the highest standards of data quality, analysis integrity, and regulatory compliance while fostering innovation in clinical trial design and statistical methodology. You will collaborate cross-functionally with key stakeholders to influence and drive strategic decisions in support of the company’s goals
Responsibilities
- Strategic Leadership: Lead the Biometrics organization in developing and executing statistical and data management strategies for clinical trials (Phase I-IV) and regulatory submissions. Drive innovative trial designs to optimize clinical development plans.
- Team Leadership & Development: Build, lead, mentor, and manage a high-performing biometrics team, including biostatisticians, statistical programmers, and data managers. Foster a collaborative and results-driven culture, promoting professional growth and knowledge-sharing across the team.
- Develop function SOPs: Lead the development, implementation, and continuous improvement of Standard Operating Procedures (SOPs) for the Biometrics function, ensuring alignment with regulatory requirements and industry best practices. Collaborate with cross-functional teams to standardize workflows, enhance operational efficiency, and maintain consistency across all biometrics activities.
- Clinical Development Support: Serve as a key member of the clinical development leadership team, contributing to the development and execution of clinical development strategies. Partner with Regulatory Affairs, Clinical Operations, and other functions to align biometrics activities with broader corporate objectives. Collaborate with medical, regulatory, pharmacovigilance, pharmacology, and clinical operation teams to ensure appropriate statistical methodologies and analysis plans are implemented. Provide statistical leadership in the design of clinical studies, including endpoint selection, sample size determination, and adaptive designs.
- Regulatory interactions: Oversee the biometrics aspects of regulatory submissions (e.g., NDA, BLA, MAA etc.), ensuring compliance with FDA, EMA, MHRA, and ICH guidelines. Lead statistical interactions with regulatory agencies, including preparation for and participation in meetings with health authorities.
- Innovation & Methodology: Champion the adoption of innovative statistical approaches (e.g., adaptive, seamless, Bayesian, etc.) and leverage emerging statistical trends and tools to enhance clinical trial efficiencies and data analysis.
- Data Quality & Integrity: Ensure the accuracy, integrity, and consistency of data throughout the clinical trial process. Oversee statistical and data management activities, including database/eCRF design, data cleaning, database lock, and statistical deliverables (SAP/SDTM/ADaM/TFL etc.), ensuring compliance with regulatory standards.
- Budget & Resource Management: Develop and manage the Biometrics budget, ensuring optimal allocation of resources to support the company’s portfolio. Provide strategic input into vendor selection and contract negotiations. Manage relationships with external CROs, ensuring adherence to timelines, budgets, and quality standards for biometrics deliverables. Monitor and review outsourced biometrics activities to ensure alignment with company standards.
- External Biometrics Collaboration: Act as the primary liaison with biometrics counterpart(s) from external partner(s), assisting seamless collaboration between the internal teams, and external partner(s) to ensure smooth and effective partnership execution.
Qualifications
- D. degree in Biostatistics or Statistics with 15+ years of relevant industry experience, including leadership roles in biometrics within the biotech or pharmaceutical industry.
- Proven track record of hands-on expertise and leadership in biometrics activities supporting clinical development programs, including successful regulatory submissions and approvals.
- Extensive experience in clinical trial design and advanced statistical methodologies, and familiar with regulatory requirements (FDA, EMA, MHRA, ICH guidelines etc.).
- Strong leadership and team-building skills, with a demonstrated ability to develop high-performing teams and foster a culture of collaboration and accountability.
- Proficiency in at least one statistical software and familiarity with CDISC standards.
- Demonstrated success in leading or implementing innovative statistical methodologies in drug development to enhance trial efficiency and increase the probability of success.
- Excellent communication and interpersonal skills, with the ability to work cross-functionally and influence decision-making.
- Experience managing biometrics-related budgets, CROs, and external vendors.
- Strong problem-solving abilities and strategic thinking skills.
Please note the compensation range reflects the Vice President title.
At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.
Salary Range
$245,000—$320,000 USD
Equal Employment Opportunity Information
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
E-Verify
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