Responsibilities:

• Design and implement strategic plans to forecast and supply drugs to global preclinical and clinical trials, using sound supply chain techniques.
• Review, interpret and implement supply forecast plans from internal or external source documents and tools.
• Coordinate complex drug manufacturing with world-class international CMOs.
• Execute supply chain inventory management processes in partnership with internal Clinical Supply Optimization Services team members and packaging partners.
• Devise and implement inventory management plans
• Maintain documents according to guidelines and relevant procedures
• Plan and manage execution of initial supplies and resupplies for assigned studies
• Ensure temperature excursion process is executed as required
• Proactively identify potential supply chain issues, provide analysis, and recommend solutions. Identify potential risks, defining and executing risk mitigation plans.
• Summarize data, prepare presentations, and make recommendations for action relative to the clinical supply chain and packaging plans
• Work with both internal and client Project teams to ensure consistent communication of clinical trial material supply status.

Requirements:

• Bachelor's Degree in Chemistry, Chemical Engineering or related field in science or engineering.
• At least 2 years of experience in similar positions within a pharmaceutical company in the manufacturing stage.
• Proven experience working with CMO, CDMO, CRO and other pharma/biotech subcontractors and service providers.
• Quality and results oriented professional.
• Ability to act as the leading Supply Chain position in the company
• Substantial knowledge in regulatory requirements for the pharmaceutical industry.
• Fluent in English with excellent writing skills.
• Good level of Spanish
• Good interpersonal relationships and team-player
• Strong problem-solving skills

We offer:

• Joining a dynamic company willing to become a partner of choice in the development of new drugs in the oncology market.
• Becoming a key player in a very focused experienced team.
• Working with partners across the world.
• Competitive package.

Responsibilities:

Lead Quality Assurance for all GxP (GMP, GCP, GLP) functions including upgrade existing Quality System, hands on QA in R&D (CMC, non-clinical, clinical).

• Define the company's strategic direction and quality objectives and be responsible for its implementation (including hands on work).
• Prepare and implement Quality Assurance policies and procedures (SOPs) and establish the company's document management system.
• Responsible for quality assurance of product development, manufacturing, testing and clinical studies at CMOs/CROs as required, including inspections and documents review to ensure quality level is maintained and guaranteed as required.
• Deploy processes to assure conformance to regulatory requirements with FDA, EMA and lead company's preparations for regulatory inspections and manufacturing.
• Support GMP production of drug product, including review and approval of Master Batch Records (MBPRs), product release, validations, stability, and other supportive studies.
• Support all QA aspects of clinical trials in collaboration with Clinical QA advisors
• Review and approve change controls, deviations and out of specification investigations, CAPA reports, complaints, audit reports, etc.
• Establish quality agreements with subcontractors.
• Review regulatory documents for IND and NDA filings.
• Manage all other QA functions (clinical and CMC) as required.

Requirements:

• Bachelor's Degree in Chemistry, Chemical Engineering or related field in science or engineering. An advanced degree is an advantage.
• At least 5 years of experience in similar positions of QA within a pharmaceutical company in the manufacturing stage.
• Proven quality leader with substantial experience in the CMO, CDMO, CRO and other pharma/biotech subcontractors and service providers
• Ability to act as the leading QA position in the company
• Substantial knowledge in regulatory requirements for the pharmaceutical industry, both of NDA and commercial stages
• Fluent in English with excellent writing skills.
• Good level of Spanish
• Experience in biologics / ADC- an advantage
• Good interpersonal relationships and team-player
• Motivated and hard worker
• Strong problem-solving skills

We offer:

• Joining a dynamic company willing to become partner of choice in the development of new drugs in the oncology market.
• Becoming a key player in a very focused experienced team.
• Working with partners across the world.
• Competitive package.

Responsibilities:

• Represent and build company image by collaborating with customers, Key external experts, national/regional scientific organizations, patient associations, government, and community organizations.
• Attend national and international meetings/ congresses/events as well as internal trainings and meetings, build effective internal and external networks
• Ensure high medical and scientific base of knowledge in all products and treatment areas in customer relations
• Collaborate with physicians on medical affairs initiatives including publications, advisory boards, medical education opportunities, training, and speaker development
• Support the medical community with up-to-date medical information, robust disease expertise, and product information. Respond to scientific enquiries from HCPs and internal colleagues

• Maximize potential of the current product portfolio in the country according to set strategy and tactical plan for Territory, participating in activities for launched and pre-launch products in all therapeutic areas
• Involvement in clinical trials and Investigator Initiated Studies if required
  • Develop a country-based scientific plan for the Territory in line with strategic Brand plans and brands opportunities
  • Provide analysis of the respective field and competition as part of the development of marketing-medical strategy; implement promotional materials in cooperation with Business Units at local and HQ level
• Implement and enforce strong ethical and compliant business practices according to international and national rules and regulations; comply fully with all AOP Orphan SOPs and Pharmacovigilance.
• Working cross functionally with local and HQ functions

Education and professional skills:

• Academic background in Pharmacy, Medical or a Life Science degree
• of 3 years’ experience in medical roles within pharmaceutical industry
• Previous experience will be considered in critical, rare disease and/or orphan drugs

Other skills:                  

• AOP 4 A’s: Agile, Ambitious, Aligned and Accountable
• Solution orientation and flexibility
• Self-motivated and proactive, ability to work to deadlines
• English fluent and Portuguese (positively valued)
• Excellent communication
• MS Office package and EPR-systems

Principales responsabilidades:

• Ser el responsable de las actividades de médico científicas de los productos a su cargo.
• Desarrollar, supervisar y liderar los aspectos médico-científicos de los estudios post comercialización de los productos a su cargo.
• Evaluar las propuestas o proyectos de investigación independientes sobre los productos bajo su responsabilidad.
• Liderar sesiones clínicas y advisory boards.
• Identificar y promover las relaciones con los líderes de opinión relevantes para sus productos.
• Dar soporte al departamento de registros y acceso, con los informes médicos requeridos por las diferentes Agencias Reguladoras o instituciones.
• Formar a las redes comerciales y otros departamentos en los aspectos clave de los productos a su cargo, así como en el posicionamiento médico frente a sus competidores.
• Apoyar a Dirección Médica en el diseño e implantación de la estrategia médica en todo el grupo, tanto a nivel nacional como internacional.

 Experiencias y competencias requeridas.

• Médico o licenciado en ciencias de la salud.
• Mínimo dos años de experiencia como Medical Advisor o como MSL.
• Excelentes capacidades de comunicación, tanto en inglés como en español.
• Gestión de KOL.
• Trabajo en equipo.

Ofrecemos.

• Trabajar en la central de una sólida compañía farmacéutica cotizada en Bolsa.
• Responsabilidades propias de headquarters.
• Colaborar en el desarrollo del área de Medical Affairs.
• Reportar directamente a Dirección Médica.
• Posibilidades reales de promoción.

Required experiences

• Life Science University degree, or similar.
• At least 10 years in the IVD industry, preferably in a leading position for an analytical system QMS development.
• Successful track record deploying and maintaining a Quality System complaint with EU (ISO 13485) and USA (cGMP, 21 CFR 820) from design to commercialization.
• Obtaining at least European regulatory approval for an IVD system. Experience in the USA will be highly valued.
• Experience obtaining Regulatory approvals of molecular diagnostics (PCR) and / or AST (Antimicrobial Susceptibility Testing) will be highly valued
• Proven track record of passing notified bodies regulatory audits.
• Expertise in leading all documentation efforts needed for regulatory agencies.
• Implementation of related regulations as IVDR (EU) 2017/746 and cGMP.
• Management experience in leading internal teams and external partners (industrial and consultants).
• Proven track record interfacing with regulatory bodies in EU and US

Required Competencies

• The candidate should be flexible to work in a dynamic start-up environment
• Objective-oriented that can deliver with aggressive program timelines
• Quality and results oriented
• Team player
• Communication skills
• Living or willing to relocate to Barcelona will be highly valued.

We offer

• Joining a solid project, led by already successful entrepreneurs in IVD and supported by top international investors.
• Develop the area from scratch, being a key member of the management team.
• Support the development of a ground-breaking new system able to save lives.
• Competitive economic package.

Main Responsibilities:

• Effective communication with subject matter experts internally and externally, to ensure alignment on program objectives, deliverables and timelines.
• Effective communication with all team members (all levels up to senior management) to evaluate and report on status of the studies.

Provide feedback to the extended team of any risks and jointly develop and implement risk mitigation plans.

• Planning, organizing, executing (coordinate / manage the development of preclinical studies, via internal execution or externalized to a CRO) assessing and reporting on assigned program tasks and ability to align objectives with project milestones, goals and strategic plans.
• Project management assistance to the preclinical team to maintain and control of the daily operations and activities of the non-clinical development project / area.
• He/she maintains and oversees the development process of the drug inside the preclinical area.
• He/she will provide comprehensive communication and coordination of assigned activities associated with preclinical development to the CSO and team. These activities include the organization, planning, timely execution, reporting and evaluation of deliverables for assigned preclinical tasks associated to the project.

Required Qualifications & Experience:

• A university degree in science (Chemistry, Biology, Pharmacy…), ideally a PhD.
• 3+ years of experience in drug development managing pre-clinical activities for innovative therapeutics (NCE/NBE) in pharmaceutical, biotechnology company or related environments.
• Knowledge of Pharmaceutical regulations/ICH/GLP/GDP.

• Experience working with both domestic and international CROs.

• Excellent verbal and written communication skills.
• Demonstrated strong collaboration and interpersonal skills and a high degree of personal integrity.

• Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent project management skills: planning, organization, and time management skills, including the ability to support and prioritize multiple, concurrent projects. 
• Cross functional team and project management experience.
• Proficient knowledge of Microsoft Excel, PowerPoint and Project software required.

Principales Responsabilidades:

• Gestionar y supervisar de inicio a fin todos los estudios clínicos de la empresa. Entre otros temas se encargará de:
• Evaluar todas las propuestas de estudios, tanto internos como externos.
• Supervisar la preparación de protocolos.
• Colaborar con Dirección Médica en la elección de CRO.
• Supervisar el trabajo de la CRO y ser la persona de contacto con ellas.
• Preparar los informes periódicos a Central, cubriendo entre otros:
• El avance de los diferentes estudios.
• Análisis financiero.
• Asegurar que se cumplen todas las PNT de la compañía.
• Elaborar los diferentes contratos.
• Ser la persona de contacto con la Agencia.
• Contacto con los responsables médicos de cada área terapéutica.

Formación y experiencia:

• Licenciatura o Phd en ciencias de la salud.
• Preferiblemente con Máster en Investigación Clínica.
• Experiencia mínima de 3-5 años como Project Manager o puesto similar.
• Inglés fluido hablado y escrito.

Otros requisitos necesarios:

• Capacidad de organización y planificación.
• Liderazgo técnico.
• Autonomía.
• Mano izquierda.

Se ofrece:

• Reportar directamente a Dirección Médica.
• Paquete económico competitivo.
• Incorporarse a una compañía Great Place to Work.

 Main responsibilities:

• Laboratory leader, responsible for all scientific aspects of experimental studies for target identification and validation
• Experience in B and T cell assays (receptor stimulation, cell-cell interactions, co-stimulations assays, FACS analysis of subpopulations, among others)
• Experience in evaluating experimental antibodies for target validation and function
• Develop and perform cell based and biochemical assays supporting various programs
• Lead and develop a newly formed team, establish state-of-the-art assays, and ensure operational excellence in execution and documentation
• Be involved in collaboration projects with academic and industry partners as well as CROs
• Experience in animal models of disease (biology and pathology) related to T and B cell function

Required experience and skills

• PhD in immunology, biochemistry or cell biology
• A proven track record with in vitro, ex vivo and/or in vivo cellular immunology, with a strong background in inflammation biology and diseases
• Significant experience in T-cell, B-cell, dendritic cell and macrophage biology
• Ideally, expertise and proven track record in biotech and/or pharmaceutical industry environment
• Support studies to demonstrate proof of concept and profile drug candidates
• Strong leadership ability along with a high level of assertiveness as well as excellent interpersonal and teamwork skills, as well as outstanding analytical thinking
• Ability to challenge the status quo and to embrace change as well as curiosity and a passion for research
• Fluent in written and spoken English with excellent communication and presentation skills