Coordenador de Bioequivalência e projetos relacionados

4 semanas atrás

São Paulo SP, Brasil Knight Therapeutics Brasil Tempo inteiro

The coordinator leads the bioequivalence and related projects for Knight products. Depending on the products and the requirements, the projects can include but not limited to pharmacological equivalence, comparative bioavailability, comparative bioequivalence, bioexemption, and comparative dissolution studies.

Responsibilities

Strategy and operations

  • Plan and provide strategic guidance on bioequivalence and related projects by mastering health authorities' regulations in LATAM.
  • Translate knowledge about bioavailability (BA), pharmacodynamic (PD), pharmacokinetic (PK) and dissolution methods to guide Knight product development.
  • Design studies to demonstrate bioequivalence of Knight products in collaboration with clinical research organization, as required.
  • Monitor, track, and ensure diligent project execution by CROs.
  • Support ethics committee submission as required.
  • Collect documentation to comply with regulatory submission and Good Clinical Practices (GCPs).
  • Review clinical documentation including (non-exclusive list): Clinical Study Protocols, case report form (CRF), Informed consent form (ICF), Statistical Analysis Plans, and Clinical Study Reports (CSRs).
  • Assess the needs of supplies to conduct the required studies and liaise with the Supply and Quality departments to ensure material availability on time for study conduct. Support to ensure readiness of the import and/or export documentation.
  • Track diligently all tasks associated with studies.
  • Develop mitigation and contingency plans to optimize operations.
  • Address questions from Health Authorities relating to bioequivalence and related studies.
  • Map all CROs to conduct pharmacological equivalence and bioequivalence studies (clinical, bioanalytics, and biostats) in LATAM.
  • Prepare and review in collaboration with legal Master Service Agreement (MSA), service agreements and confidentiality agreements with the service providers.
  • Plan for future studies i.e. CRO identification, selection, and budget negotiation.
  • Monitor CRO’s activities execution in accordance to plan and risk assessment.
  • Analyze data and interpret results to guide decision-making.

Compliance

  • Comply with ICH and GCP requirements.
  • Coordinate with Pharmacovigilance to comply with safety reporting requirements.
  • Develop and update SOPs and working instructions to meet GCP requirements.
  • Develop and comply with internal SOPs, policies, and ethical standards.

Cross-functional and external stakeholders collaboration

  • Develop and maintain relationship with internal stakeholders, CROs, and regulators.
  • Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner.

Critical Interfaces:

  • Coordinate with key stakeholders to comply with the regulations for pharmacological and/or therapeutic equivalence between Knight products and reference products.
  • Operationalize effectively bioequivalence studies and other related projects to speed up commercialization.

Qualifications

  • Advanced science degree (PhD, PharmD, MSc) in:
  • Drug Development
  • Clinical trial Development

Desirable:

  • Broad knowledge of FDA, WHO, ANVISA and other LATAM agencies regulations and guidelines, as well as GCP/GLP and ICH.

Experience:

  • 5 years of relevant experience in bioequivalence
  • Demonstrated knowledge of regulatory environment relating to demonstration of therapeutic equivalence
  • Significant experience in reviewing Clinical Study Protocols, Statistical Analysis Plans, and Clinical Study Reports

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