Sanaria
Sanaria

Employment

Sanaria is currently expanding its activities and is accepting inquiries and resumes for the positions listed below. If you are interested in furthering your career with us please send the following information to careers@sanaria.com:

  • Cover letter
  • Resume or CV
  • Salary requirements

Sanaria is an equal opportunity employer.


AVAILABLE POSITIONS:

Scientist, Vaccine Extraction and Immunology
Physician Investigator, Malabo, Equatorial Guinea
Director Médico
Regulatory Affairs Specialist

Scientist, Vaccine Extraction and Immunology

We currently have an opening for a Scientist in the Vaccine Extraction and Immunology Group.

Responsibilities

  • The Scientist will actively participate in tasks and activities in support of Sanaria's GMP manufacturing, clinical trials and research efforts.
  • This position primarily involves participation in activities related to extraction of the sporozoite stage of the malaria parasite and characterization of the parasite's biological attributes in cell culture assays and immunological properties in appropriate experimental models.
  • The incumbent is also expected to participate in vaccine production related activities in full compliance with cGMPs.

Requirements

  • Qualified candidates must have a PhD Degree in Biology or a related discipline, with 3-5 years of post-doctoral experience in Clinical and/or Experimental Immunology.
  • Excellent communication, writing, team work and organization skills and the willingness to learn new experimental techniques in a highly collaborative environment are required.
  • Ability to write up technical reports, summaries, protocols and perform quantitative analyses, and proficiency in Microsoft excel and Microsoft word is a must.
  • Experience with microscopy and tissue culture in the field of Malaria is desirable. Knowledge of state-of the art immunological techniques, hands-on experience working with Flow Cytometry, and sterile/aseptic processing experience is also required.
  • The ability to work in a fast-paced, collaborative team environment with multiple and competing priorities is essential, together with a strong demonstration of individual initiative.

Physician Investigator, Malabo, Equatorial Guinea

The Physician Investigator will support Equatorial Guinea Malaria Vaccine Initiative (EGMVI) Stage 3 activities on site in Malabo, Equatorial Guinea for the duration of the project, approximately 2-3 years. The physician must be fully bilingual (written and spoken Spanish and English) and experienced in clinical research / field epidemiology. This position will be the local Sanaria project director, interact closely with onsite collaborators, partners and contractors, and assure that Sanaria's project objectives are met. Periodic visits to other sites in Africa, especially Tanzania, where Sanaria is sponsoring research trials, to represent Sanaria's interests in similar fashion, will be an important responsibility. The physician investigator will maintain frequent and comprehensive communication links with Sanaria Clinical personnel and report to the Chief Medical Officer.

Responsibilities

  • Liaise with EGMVI collaborators including other Sanaria staff on site to accomplish Sanaria's research objectives.
  • Assure adherence to Good Clinical Practices by all clinical research activities and personnel, with an emphasis on research volunteer safety.
  • Assure the integrity of all clinical data.
  • Carry out work plans / project activities, and maintain project timelines.
  • Support local protocol development, protocol approvals and clinical trial execution, including on-site monitoring and quality control.
  • Communicate regularly and frequently with Sanaria clinical staff.
  • Author written project reports and other documents.
  • Serve an ambassadorial function, promoting excellent collaborative relationships with partners and host nationals.
  • Attend meetings of the International PfSPZ Consortium and other meetings, as tasked.
  • Conduct at least yearly visits to Sanaria's contracted Occupational Health physician.

Qualifications

  • Doctor of Medicine degree and post-graduate medical training.
  • Licensure to practice medicine in home country.
  • 5+ years of clinical research / field epidemiology experience, ideally in the setting of international partnerships.
  • Good clinical practices certification.
  • Basic and advanced cardiac life support certification.
  • English and Spanish language fluency.
  • Preferred:
  • Ability to speak French.
  • Board certification in a primary care specialty (e.g. internal medicine, pediatrics, family medicine).
  • Infectious diseases fellowship training.

Work Environment

The incumbent will be housed in Equatorial Guinea and provided transportation and security according to the standards of our administrative partner Medical Care Development International (MCDI). MCDI maintains American and other foreign national staff full time in Malabo with security and health established as high priorities. Quality office space will be provided that is co-located with colleagues and collaborators to assure a congenial professional environment. Environmental hazards include potential exposure to human blood and to local disease hazards including identified and unidentified transmissible agents. Living in Equatorial Guinea may involve capricious events including police stops, local disturbances, inclement weather and travel hazards.

Director Médico

Se requiere un médico investigador para apoyar las actividades de fase III y fase IV de la Iniciativa de la Vacuna contra el Paludismo en Guinea Ecuatorial (EGMVI) en Malabo, Guinea Ecuatorial, durante un mínimo de un año, y preferiblemente al menos 3 años. El médico debe ser completamente bilingüe (escrito y hablado en español e inglés) y tener experiencia en la investigación clínica / epidemiología de campo. Él o ella será director local del proyecto de Sanaria, interactuar estrechamente con los colaboradores del sitio, socios y contratistas, servir como investigador principal o co-principal de los ensayos clínicos de Sanaria y asegurar que se cumplan los objetivos del proyecto de Sanaria. Posibles visitas periódicas a otros sitios en África donde Sanaria está patrocinando ensayos de investigación, para representar los intereses de Sanaria de manera similar serâ una responsabilidad adicional. Él o ella mantendrá la comunicación frecuente y completa con el personal clínico y reportar al Director Médico de Sanaria.

Obligaciones y responsabilidades esenciales

  • Representar los intereses de Sanaria en Guinea Ecuatorial, y otros sitios clínicos patrocinados en África que le sean asignado, incluyendo la comunicación de los objetivos, los planes y el progreso de Sanaria.
  • Hacer enlace los colaboradores de EGMVI incluyendo los investigadores y el personal del Instituto de Salud Ifakara (IHI), el Ministerio de Salud y Bienestar Social de Guinea Ecuatorial, Medical Care Development International (MCDI), y el Instituto de Salud Pública y Tropical (Swiss TPH), Marathon Oil y otros financiadores, y otras instituciones que pueden interactuar con el proyecto, y con otro personal de Sanaria dentro y fuera del sitio, para promover y lograr los objetivos de Sanaria.
  • Servir como investigador principal (o investigador co-principal, junto con un co-investigador principal africano) de los ensayos clínicos patrocinados por Sanaria en Guinea Ecuatorial, incluidos los ensayos de la vacuna PfSPZ Vaccine y otros productos de Sanaria bajo la supervisión de la FDA de los EE.UU.
  • Como IP, o co-IP, dirigir a un equipo internacional de investigación clínica con sede en Guinea Ecuatorial en la ejecución de estos ensayos clínicos.
  • Trabajar de forma independiente o con el co-IP para asegurar el cumplimiento de las Buenas Prácticas Clínicas en todas las actividades de investigación clínica por parte del personal del estudio, con énfasis en la seguridad de los voluntarios de investigación.
  • Trabajar de forma independiente o con el co-IP para asegurar la integridad de todos los datos clínicos, incluida la revisión de archivos de voluntarios, promoviendo procesos para validar la precisión de los datos y el ingreso correcto a la base de datos y la generación de planes de acción correctiva / acción preventiva (CAPA) para corregir fallas del proceso.
  • Llevar a cabo planes de trabajo / actividades de proyectos adicionales según lo encomendado, y mantener los plazos del proyecto.
  • Apoyar la generación, revisión y finalización de los documentos críticos, incluyendo los protocolos clínicos, formularios de consentimiento, acuerdos del ensayo clínico, acuerdos de transferencia de materiales, planes de monitoreo, planes de gestión de datos, planes de análisis estadístico, manuales de calidad, manuales de procedimientos, revisiones de datos, informedades de seguridad, compilación de datos pedidos, etcétera, en algunos casos sirviendo como autor principal.
  • Sirvir como mentor e instructor para el personal de ensayos clínicos, en particular el personal de Guinea Ecuatorial.
  • Comunicarse regularmente y con frecuencia con el personal clínico de Sanaria (y otro personal según corresponda).
  • Apoyar al personal visitante de Sanaria y, cuando pedido, a otro personal.
  • Servir en una funciín de embajador, promoviendo excelentes relaciones de colaboraciín con socios y nacionales anfitriones.
  • Completar tareas similares (1-12) en otros sitios clínicos patrocinados por Sanaria, como se le asigna.
  • Participar en las teleconferencias de Sanaria para apoyar las actividades de Sanaria.
  • Asistir a las reuniones del Consorcio Internacional PfSPZ y otras reuniones, según lo encomendado.
  • Realizar otras tareas razonables asignadas por la administraciín.

Deberes y responsabilidades adicionales

  • Promover el desarrollo profesional de cualquier personal de Sanaria que se encuentre en el mismo lugar.
  • Promover el desarrollo profesional de los anfitriones nacionales y los colegas colaboradores a medida que surjan oportunidades.
  • Proporcionar servicios de traducción oral según sea necesario.
  • Revisar los documentos de la versión en español para asegurar la traducción correcta según sea necesario.
  • Participar en la revisión y evaluaciín del progreso local y sugerir correcciones / revisiones a mitad de camino de los planes para mejorar la eficacia y el éxito de la ejecución del proyecto.
  • Servir como autor de resúmenes e informes científicos y realizar presentaciones orales y de poster, que describen los logros de investigación de los miembros del consorcio a la comunidad de desarrollo de vacunas contra el paludismo y otros ámbitos apropiados (reuniones, simposios, talleres, publicaciones, consultas, comunicados de prensa), y obtener una revisión del supervisor antes de la presentación.

Regulatory Affairs Specialist

Sanaria is now embarking on an ambitious program designed to lead to licensure, and will be conducting clinical trials at multiple sites in Africa, Europe, and the United States. Sanaria is currently recruiting for a Regulatory Affairs Associate experienced with US (and preferably international) regulatory requirements and procedures, ideally with background in vaccine (or drug) development.

Responsibilities

  • Support regulatory submissions (INDs, Master Files, CTAs, IMPDs, BLA, etc) for product development process
  • Responsible for preparation and submission of standard regulatory documentation to support regulatory filings including, but not limited to, CMC and clinical amendments, IND annual reports, Investigator's Brochure (IB), safety reports, clinical trial progress reports
  • Responsible for development and review of CMC modules in coordination with the Manufacturing team to ensure CMC updates and reporting requirements are met
  • Work in close collaboration with the clinical and data teams to obtain the necessary clinical data and to develop clinical summaries and data presentation for IND annual reports, IBs and safety reports
  • Development, writing, editing, and finalization of Investigator's Brochure for submission to regulatory authorities
  • Development of regulatory documents in accordance with eCTD requirements
  • Coordination of team review and editing of regulatory documentation in close collaboration with Sanaria's Clinical, Manufacturing and Quality teams, and external collaborators - Principal Investigators and site clinical staff
  • Track and manage submissions and timelines for the regulatory filings
  • Development of SOPs, working instructions and document templates
  • Register and maintain Sanaria's clinical trials information on the clinicaltrials.gov registry and EudraCT database

Qualifications

  • Bachelor's or Master's degree in science- or public health-related field
  • 1-4 years of prior FDA regulatory experience in drugs/biologics is required
  • Excellent oral and written communication skills
  • 1-4 years of prior experience in writing and developing regulatory documents such as clinical, non-clinical and CMC sections of INDs, BLA, DMFs, amendments, annual reports and IBs
  • Experience with eCTD is required
  • Demonstrated knowledge and understanding of US and/or international regulations related to clinical trials and licensure/marketing applications
  • Strong analytical skills/excellent interpersonal skills/strong leadership abilities
  • High attention to detail and strong organization and time management skills
  • Excellent computer skills (Microsoft Office Suite)
  • U.S. citizenship or permanent eligibility to work legally in the U.S. is required

 

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