Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company which engineers targeted immunotherapies, seeking to improve patient outcomes through the power of innate immunity. Affimed’s fit-for-purpose ROCK® platform allows innate immune engagers to be designed for specific patient populations. We are developing single and combination therapies to treat cancers.

To strengthen our growing Research & Development team in Heidelberg, Germany, we are looking for a full-time

Senior Lead Non-Clinical Development (f/m/d)

(Reference No. R2208)

The successful candidate will be responsible for the non-clinical development of bispecific antibody drug candidates in oncology during the program life cycle and will be a key driver for generation and implementation of the overall scientific strategy of the program. In this capacity, the Senior Lead Non-Clinical Development will head a Non-Clinical Development Team tasked with conceptualization and execution of all non-clinical development activities and will be an integral member of an international, cross-functional Program Team overseeing development activities and program strategy.

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Key Responsibilities

• Drive non-clinical drug development activities for a bispecific antibody drug candidate in immuno-oncology during program life cycle as leader of the Non-Clinical Development Team
  • Ensure development and execution of non-clinical program plan in alignment with program strategy covering important milestones such as lead nomination, IND submission(s) and filing for market authorization (as applicable for respective program status)
  • Collaborate with pre-clinical scientists and other 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 strategic cross-functional Program Team
  • Inform on non-clinical strategy and deliverables and obtain guidance
  • Serve as non-clinical subject matter expert and provide respective input to program strategy
  • Act as a key driver for conceptualization and execution of overall scientific program strategy in collaboration with translational and clinical counterparts
  • 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
• Ensure availability of study reports and present program status at internal meetings
• Represent company at international scientific congresses and business meetings, including presentation of program status

Required Qualifications:

Professional qualifications, expertise and skills

• PhD in Life Sciences (Biology, Biochemistry, Medicine, Pharmacy) or MD
• Demonstrated strong knowledge of immuno-oncology and experience with biologics drug development (>5 years)
• Track record of a leading role in a matrix setting
• Experience with regulatory documents and interactions as key contributor
• 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

Opportunity

The successful candidate will have the unique opportunity to take on a leading scientific role in the development of an innovative antibody drug for cancer immunotherapy within a highly motivated, multidisciplinary and collegial team, united in its goal to stop cancer from ever derailing patient’s lives.

For any queries, please contact Susanne Hering (Tel: 06221 6743 675, e-mail: s.hering@affimed.com).

April 2022