Requisitos:

·       Perfil científico/clínico con titulación universitaria en ciencias de la salud, valorable PhD.

·       Experiencia mínima de 3-4 años en posición similar.

·       Capacidad de interaccionar con líderes de opinión y con los diferentes stakeholders internos y externos.

·       Conocimiento de gestión de estudios clínicos y regulación de la industria farmacéutica.

·       Nivel alto inglés.

Ofrecemos:

• Entrar en una línea estratégica de la empresa, con dos lanzamientos de investigación propia, en los próximos 12 meses.
• Trabajar en una compañía Best Place to Work en Europa y en España.
• Posibilidades de desarrollo profesional.
• Interesante paquete retributivo.

Main responsibilities:

• Identify, prioritize, and lead scientific assessment of external innovative technological opportunities
• Work closely with cross-functional teams (BD, R&D, Med Affairs, IP, Clinical, Industrial) for the continued evaluation of external opportunities
• Cultivate and expand existing networks in the US/Europe - biotech, pharma, venture, research institutes and academic communities - to ensure high quality deal flow for the company
• Drive awareness of the company and position it as a partner of choice
• Collaborate with corporate leadership to help refine / refresh the company’s strategy as appropriate and drive development of external innovation strategy

Requirements and skills:

• D. in life science with Post-doc
• Exceptional scientific credentials and external profile
• Minimum 5 years’ experience in biotechnology/pharmaceutical industry (or in related life sciences fields including venture capital and/or technology transfer)
• Extensive knowledge of new technologies and platforms in the context of drug discovery and development.
• Proven ability to lead technical due diligence efforts/teams
• Proven strategic thinking related to product development and pipelines
• Ability to anticipate the evolution of the marketplace and the competition to maintain advantage as it pertains to business model creation, innovation acquisition and collaborations
• Knowledge of Drug Discovery, Development and Intellectual Property Processes
• Strong analytical skills and the ability to communicate complex information and analyses to a variety of scientific and non-scientific audiences

Main responsibilities:

• Lead clinical assessment of external innovative opportunities analysing both the medical need as well as the clinical roadmap to achieve regulatory approval.
• Work closely with cross-functional teams (BD, R&D, Med Affairs, IP, Clinical, Industrial) for the continued evaluation of external opportunities
• Cultivate and expand existing networks in the US/Europe - biotech, pharma, venture, research institutes and academic communities - to ensure high quality deal flow for the company
• Drive awareness of the company and position it as a partner of choice
• Collaborate with corporate leadership to help refine / refresh the company’s strategy as appropriate and drive development of external innovation strategy

Requirements and skills:

• MD, preferred Clinical pharmacologist specialist
• Exceptional scientific credentials and external profile
• Minimum 5 years’ experience in biotechnology/pharmaceutical industry (or in related life sciences fields including venture capital and/or technology transfer) supporting the medical and clinical evaluation of external innovation
• Experience in designing clinical trials in several therapeutic areas.
• Knowledge of Drug Discovery, Development and Intellectual Property Processes
• Strong analytical skills and the ability to communicate complex information and analyses

Main responsibilities:

• Identify, prioritize, and lead scientific assessment of external Immunology opportunities
• Work closely with cross-functional teams (BD, R&D, Med Affairs, IP, Clinical, Industrial) for the continued evaluation of external opportunities
• Cultivate and expand existing networks in the US/Europe - biotech, pharma, venture, research institutes and academic communities - to ensure high quality deal flow for the company
• Drive awareness of the company and position it as a partner of choice
• Collaborate with corporate leadership to help refine/refresh the Immunology strategy as appropriate and drive development of external innovation strategy

Requirements and skills:

• D. in life science with Post-doc
• Exceptional scientific credentials and external profile
• Minimum 5 years’ experience in biotechnology/pharmaceutical industry (or in related life sciences fields including venture capital and/or technology transfer)
• Extensive Immunology expertise in the context of drug development and / or partnering.
• Proven ability to lead technical due diligence efforts/teams
• Proven strategic thinking related to product development and pipelines
• Ability to anticipate the evolution of the marketplace and the competition to maintain advantage as it pertains to business model creation, innovation acquisition and collaborations
• Knowledge of Drug Discovery, Development and Intellectual Property Processes
• Strong analytical skills and the ability to communicate complex information and analyses to a variety of scientific and non-scientific audiences

Main responsibilities:

• Coordinate cross-functional due diligence efforts on external technologies on appropriate timings
• Coordinate the External Innovation Unit’s portfolio management activities including follow-up of projects, identify decision gates, prioritization, etc…
• Facilitate prioritization and cross-functional business alignment on strategic initiatives, participate in strategic planning and management of product roadmap.
• Interact with internal stakeholders such as communication, IR, Strategy office, etc… when needed to deliver metrics, reports, etc…
• Interact with external stakeholders (Asebio, public institutions, etc…) in order to update the External Innovation Unit’s external innovation activities, foster collaborations, search external funding initiatives, etc…
• Create and maintain a network of potential partners in the industry and in the venture capital community and technology transfer sectors.
• Ensure continuous monitoring of the landscape in the core portfolio.
• Prepare assessments and recommendations to be presented to executive leadership.

Requirements and skills:

• Life science degree with a MBA with a strong business acumen and a demonstrated track record of driving innovation in a technology focused portfolio
• Minimum 5 years’ experience in biotechnology/pharmaceutical industry (or in related life sciences fields including venture capital and/or technology transfer) in Innovation Management
• Experience in portfolio management
• Extensive knowledge of drug development process

Main responsibilities:

• Direct the development of clinical strategies and plans to integrate the company’s compounds into the standard practice of immuno-oncology.
• Lead and supervise all aspects of Clinical Development & Clinical Operations.
• Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
• Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders.
• Oversight of CROs and other vendors as necessary.
• Give input into portfolio and pipeline development and advancement.
• Provide clinical support and contribute, together with other members of the management team, to the development of the overall corporate strategy
• Represent the company and its programs in front of external audiences, such as investment, medical and regulatory communities, as well as pharma and biotech companies.
• Identify, develop, and maintain strong working relationships with investigators and KOLs.
• Provide input into non-project work and the development of clinical R&D procedures.
• Lead the preparation of regulatory briefing documents and clinical elements of regulatory submission documents (IND, CTA, NDA, BLA, MAA).
• Serve as the subject matter expert for Clinical/Medical programs to the rest of the organization.
• Step in to represent the CMO on an as-needed basis.

Requirements and skills:

• MD with solid Medical Affairs & Clinical Development industry experience.
• Must have experience with and strong knowledge of Oncology drug development; experience in Immuno-Oncology is a plus.
• Solid experience in leading clinical groups including clinical/medical affairs and clinical operations.
• A proven success record in Phase I-III clinical research studies and trial design as well as successful submission of IND and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s).
• Knowledge of relevant EMA and FDA regulations and guidelines as well as those of other
• health authorities; experience in interactions with EMA and FDA personnel is essential;
• experience in interactions with other health authorities a plus.
• Must have a thorough knowledge of clinical research concepts, practices, and applicable
• regulations such as GCP and ICH guidelines.
• Experience in translational medicine, clinical pharmacology and early stage development incl. CMC is desirable.
• Must have excellent leadership and interpersonal skills.
• Excellent verbal and written communication skills. Comfortable presenting in public meetings or expert level settings; demonstrated excellence in stakeholder management at any level.
• Agility and resourcefulness in response to unexpected challenges or dynamic situations.
• Ability to make difficult, high-stake decisions and provide credible leadership.
• Patience, fairness and loyalty in interactions with colleagues.
• Willingness to travel and work long hours as needed.
• Cross-functional and adaptive; the company has a lean team and versatility to support non-core activities is a plus.

• Gestión transversal de todos los aspectos relacionados con los proyectos de licencia y suministro de medicamentos propios a laboratorios terceros, siendo responsable de la línea de productos encomendada.
• Eso incluye:
  • Análisis de mercados e identificación de oportunidades.
  • Selección de potenciales socios.
  • Presentación de productos a potenciales socios.
  • Negociación de contratos.
  • Colaboración y coordinación entre distintos departamentos internos, tales como regulatorio, investigación, producción, etc.
  • Apoyo a socios en materias de marketing, planificación de producción, stocks,..

• Experiencia mínima de tres años, en posición similar dentro del sector farmacéutico, ya sea con medicamentos innovadores, genéricos o biosimilares.
• Se valorará especialmente experiencia en Out-Licensing internacional.
• Formación en ciencias de la vida, especialmente en Farmacia.
• Se valorará formación adicional en negocio, tipo MBA, comercio internacional, etc.
• Nivel de inglés muy alto.
• Se valorará la experiencia en gestión de proyectos.
• Se valorará los conocimientos de Market Access internacional.
• Capacidad de trabajo en equipo.
• Autonomía y proactividad.

• Incorporarse a un sólido grupo farmacéutico en fase de expansión.
• Posición de alta visibilidad.

• Communicate the Voice of Customer to internal development teams to frontload product development that ensures value creation in new products.
• Closely manage the lifecycle for responsible products and significantly contribute to the company’s growth and profitably through portfolio management, strategic pricing and new product enhancements.
• Provide market intelligence, business cases and Voice of Customer requirements for new product development or new market program development within the own area of responsibility.
• Create and implement clear value proposition /positioning for covered products incorporating Sample to Insight messaging.  Includes training regional teams for new product launches and driving uptake of new launches with Comm Ops.
• Product/platform life cycle management and strategic product development roadmap that considers phasing out older or less profitable product lines for new innovations.
• Strategic pricing that generates maximum profitability based on value product brings to the market and current competitive atmosphere. Actively incorporating Value Based Pricing principles in new product launches.
• Be up-to-date on the latest regulatory and clinical trial requirements.

• Education in Life Sciences, MBA is a plus.
• 3 years experience in clinical IVD marketing/ commercial organizations.
• Experience in molecular diagnostics is a plus.
• Some customer facing and international business experience is required.
• Commercial mind-set able to adapt to different markets Europe, US, and Emerging Markets.
• Excellent interpersonal and communication skills at all levels and with a variety of stakeholders incl. effective KOL management
• Ability to advance projects and promote collaboration in a matrixed environment.
• Strategic vision, ability to make and defend difficult, high-stake trade-off decisions.
• Agile with intellectual curiosity, resourcefulness in response to unexpected challenges or dynamic situations.
• Willingness to travel extensively.
• Fluency in English.

-Coordinate the validation of analytical methods to quantify drugs, anti-drug antibodies or biomarkers in biological matrices by ligand binding assays (ELISA, MSD) according to international guidelines.
-Coordinate sample analysis projects, including regulated and non-regulated, pre-clinical and clinical studies.
-Manage method development projects.
-Deliver extensive and effective communication with sponsors and timely delivery of results.
-Organize and line-manage laboratory personnel.
-Effectively resolve technical and regulatory issues.
-Actively support Senior Management and participate in strategic projects to optimize procedures.

-PhD, MSc or BSc in biology or related subject.
-Minimum 3-years’ experience in bioanalytical CROs.
-Experience working with ELISA, MSD or other Ligand Binding techniques.
-Experience in managing validation and sample analysis projects for determination of Immunogenicity and PK for pre-clinical and clinical studies
-Deep understanding of international bioanalytical guidelines for PK and Immunogenicity assay validation, and experience working under GLP/GCP regulations.
-Experience working with LIMS systems.
-Experience working with cell culture techniques will be highly valued
-Excellent level of English (Spanish – nice to have).

-Opportunity to work and contribute to the success of an expanding CRO.
-Solid scientific team with career growth opportunities.
-Cutting edge laboratory with the latest technology.
-International and multicultural environment in company based in Barcelona.
-Diligent, professional organization, with a human touch.