Project Leader Non-Clinical Development

Project Leader Non-Clinical Development

Affimed

Heidelberg, Germany

The successful candidate will be responsible for the non-clinical development of bispecific antibody drug candidates in oncology from lead nomination to IND submission. In this capacity, the Project Leader Non-Clinical Development will head a Non-Clinical Development Team tasked with executing and coordinating all non-clinical development activities and will be an integral member of an international, cross-functional Program Team overseeing development activities and program strategy.

Responsibilities

  • Lead non-clinical drug development activities for a bispecific antibody drug candidate in immuno-oncology from lead nomination to IND submission:
    • Develop non-clinical program plan in alignment with program strategy;
    • Collaborate with pre-clinical scientists and subject matter experts to execute internal and external program-related R&D activities to characterize in vitro and in vivo pharmacology of the drug candidate;
    • Work closely with toxicology experts and CMC team to align non-clinical development activities with manufacturing plan and toxicology program;
    • Initiate and execute research collaborations with external collaborators and vendors;
    • Drive execution according to defined timelines and budget in collaboration with Program Management.
  • Represent Non-Clinical Development Team as Non-Clinical Lead in cross-functional Program Team:
    • Serve as subject matter expert for target and disease biology;
    • Present status of non-clinical development;
    • Take a leading role to shape program strategy by providing scientific expertise;
    • Support Program Team in preparing program recommendations and presentation to management;
    • Support Program Team in budget planning.
  • Prepare regulatory documents and support Program Team in interactions with regulatory authorities;
  • Prepare study reports and present program status at internal meetings;
  • Represent company at international scientific congresses and business meetings, including presentation of program status.

Requirements

Professional qualifications, expertise and skills

  • PhD in Life Sciences (Biology, Biochemistry, Medicine, Pharmacy);
  • Demonstrated strong knowledge of immuno-oncology and experience with biologics drug development to IND in a leading role (>3 years);
  • Strong leadership skills and a team-player disposition;
  • Excellent oral and written communication skills, capable of influencing a broad spectrum of stakeholders;
  • Full professional proficiency in English.

Competencies

  • High intellect, hard-working and ambitious individual with a commitment to make a significant contribution to new therapies;
  • Fully assume responsibility, work proactively and independently;
  • Ability to interact within a multi-disciplinary environment with multiple stakeholders;
  • Work in a highly structured and organized manner;
  • Passionate, inclusive, open-minded, collaborative and forward-thinking approach;
  • Analyze, understand and clearly communicate complex scenarios;
  • Manage tasks without having direct authority;
  • Work under pressure if required, adapt to changes quickly and frequently;
  • Possess a results-oriented mindset;
  • Be committed to learn, adapt and improve continuously.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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