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Senior Vice President of Statistical Science
2 months ago
Salario:
Acrivon es una empresa biofarmacéutica en etapa clínica que desarrolla medicamentos de oncología de precisión, emparejándolos con pacientes cuyas tumores se predice que serán sensibles a cada medicamento específico mediante la utilización de la plataforma de identificación de pacientes respondedores basada en proteómica de Acrivon, conocida como AP3. Esta plataforma está diseñada para medir los efectos específicos de los compuestos en toda la red de señalización de proteínas de las células tumorales y los mecanismos de resistencia inducidos por fármacos de manera imparcial. Estas capacidades distintivas permiten la aplicación directa de AP3 para la optimización del diseño de fármacos para la actividad de monoterapia, la identificación de combinaciones de fármacos racionales y la creación de diagnósticos complementarios OncoSignature específicos de fármacos que se utilizan para identificar a los pacientes más propensos a beneficiarse de los candidatos a fármacos de Acrivon.
Acrivon está avanzando actualmente su candidato principal, ACR-368 (también conocido como prexasertib), un inhibidor selectivo de pequeñas moléculas que se dirige a CHK1 y CHK2 en un ensayo de fase 2 potencialmente registral en múltiples tipos de tumores. La compañía ha recibido la designación de Fast Track de la FDA para la investigación de ACR-368 como monoterapia basada en la sensibilidad predicha por OncoSignature en pacientes con cáncer de ovario o endometrial resistente a platino. La prueba OncoSignature de ACR-368, que aún no ha obtenido la aprobación regulatoria, ha sido evaluada extensamente en estudios preclínicos, incluyendo dos estudios separados, ciegos y diseñados prospectivamente sobre biopsias tumorales recolectadas de ensayos de fase 2 de terceros en pacientes con cáncer de ovario tratados con ACR-368. La compañía ha reportado datos clínicos iniciales positivos de su ensayo de fase 2b con intención registral de ACR-368 para pacientes con cáncer de ovario o adenocarcinoma endometrial recurrente, localmente avanzado o metastásico resistente a platino, incluyendo una tasa de respuesta objetiva confirmada (según RECIST 1.1) del 50% en el cohorte prospectivo de pacientes positivos para OncoSignature que fueron evaluables para eficacia. La FDA ha otorgado la designación de Dispositivo Innovador para el ensayo OncoSignature de ACR-368 para la identificación de pacientes con cáncer de ovario que pueden beneficiarse del tratamiento con ACR-368. Además de ACR-368, Acrivon también está aprovechando su plataforma de medicina de precisión AP3 para desarrollar programas en etapa preclínica impulsados por co-cristalografía, que incluyen ACR-2316, un potente inhibidor selectivo de WEE1/PKMYT1 diseñado para una actividad superior como agente único, como se demostró en estudios preclínicos en comparación con inhibidores de referencia, y un programa de ciclo celular con un objetivo no divulgado.
Descripción del Puesto:
Estamos buscando un Vicepresidente de Biostatística experimentado y dinámico para liderar los esfuerzos de biostatística de Acrivon en programas de desarrollo clínico y diagnóstico. El candidato exitoso desempeñará un papel crítico en la estrategia y ejecución del desarrollo clínico impulsado por biomarcadores de Acrivon, colaborando en el desarrollo de nuestras pruebas de biomarcadores predictivos adaptadas a fármacos y trabajando estrechamente con el equipo de la plataforma de biomarcadores de Acrivon para desbloquear el valor y la promesa de nuestros medicamentos de precisión en oncología y más allá. Esta posición reportará al Director de Operaciones.
Responsabilidades:
- Colaborar estrechamente con estadísticos de CRO en el diseño, desarrollo de protocolos, desarrollo de planes de análisis estadístico e interpretación de estudios de fármacos exploratorios y decisivos, asegurando una metodología robusta y el cumplimiento de los estándares regulatorios.
- Trabajar en conjunto con estadísticos de socios diagnósticos en el diseño, desarrollo de protocolos, desarrollo de planes de análisis estadístico e interpretación de estudios críticos, incluyendo estudios de desarrollo, verificación y validación, asegurando una metodología robusta y el cumplimiento de los requisitos de QSR.
- Alinear la estrategia y actividades de biostatística con equipos multifuncionales de Acrivon.
- Apoyar interacciones cercanas con otras funciones, incluyendo investigación, desarrollo clínico, desarrollo de biomarcadores, ciencia de datos, asuntos regulatorios y calidad.
- Modelar y analizar conjuntos de datos críticos de estudios de desarrollo clínico y diagnóstico para apoyar la toma de decisiones en tiempo real y la evolución de la estrategia. Este es un proceso práctico.
- Apoyar las presentaciones a la FDA y asistir a reuniones con la FDA, proporcionando las contribuciones de biostatística requeridas.
Calificaciones:
- Doctorado en biostatística, estadística, matemáticas o campo relacionado.
- Al menos 10 años de experiencia en biostatística para desarrollo clínico y diagnóstico, con experiencia en diagnósticos complementarios preferida.
- Conocimiento sólido de los métodos estadísticos subyacentes a los estudios de desarrollo y validación diagnóstica y clínica, incluyendo modelado de regresión de efectos mixtos, DOE, modelado binomial, modelos de estabilidad, modelos de tiempo hasta el evento, bootstrapping, pruebas de asociación en variables categóricas, etc.
- Habilidad en la aplicación práctica de métodos estadísticos, con amplia experiencia en R o SAS.
- Conocimiento del proceso de co-desarrollo de fármacos y diagnósticos, particularmente para diagnósticos complementarios.
- Excelentes habilidades de pensamiento estratégico y resolución de problemas.
- Capacidad demostrada para trabajar de manera efectiva en un entorno colaborativo y dinámico.
- Fuertes habilidades de comunicación e interpersonales, competente en presentar datos científicos y estrategias a partes interesadas, incluyendo audiencias no científicas.
Acrivon Therapeutics se enorgullece de ser un empleador que ofrece igualdad de oportunidades y de proporcionar oportunidades equitativas a todos los empleados y solicitantes de empleo sin distinción de raza, color, religión, sexo o identidad de género, origen nacional, edad, discapacidad, orientación sexual o genética.
