Oncologist as Clinical Programm Lead with focus on Solid Tumors (m|f|d)

Miltenyi Biomedicine is a newly established international biopharmaceutical company that develops innovative cell and gene therapies. We are focused on bringing cancer treatments and regenerative therapies to patients. Our initial focus is on difficult to treat hematological cancers using CAR-T technology whilst exploring treatments for solid tumors.  We are currently in discussion with the FDA, EMA and Japanese health authorities regarding initiating pivotal Phase II trials. We strongly believe that despite promising developments, there is significant room to improve on current cancer therapies.

Your role

  • In your new role, you are responsible for the design and preparation of early clinical development plans throughout the clinical development lifecycle from start of development to submission and registration.
  • You are accountable for the medical oversight of the clinical development program, including clinical trial protocol development, study conduct, analysis and reporting as well as for the continuous benefit risk assessment. You provide medical leadership in regulatory meetings and for the submission strategy, and contribute to the assessment of safety related issues and to regulatory dossiers.
  • In alignment with the clinical development plans, you supervise clinical trial protocols, contribute to relevant Investigator Brochures (IBs), Clinical Trial Reports and approve scientific publications within your projects.
  • You identify the need of studies to be conducted and provide input to Medical Affairs strategy documents.
  • Externally, you are recognized as an expert in your respective disease area and represent our company towards external experts and organizations. As part of the cross-functional Global Clinical Development Team you represent Miltenyi Biomedicine in internal & external committee meetings like advisory boards, adjudication committees and at clinical trial data monitoring boards. You act as a decision maker in these disease area-related meetings/committees and gather external expert advice for your development projects.

Your Profile

  • You are a medical doctor with a specialization in Oncology / Solid Tumors (“Facharzt/Fachärztin”), PhD is advantageous.
  • You have a clinical development track record of several years of industry experience (pharma or biotech companies and/or CRO’s). You are familiar with ICH and GCP requirements as applicable for Clinical Development. Experience in the execution of clinical trials (phase 1b / II) is an add on.
  • Experience in pancreatic or brain tumor, lung or ovarian cancer drug development is an advantage as well as in-depth pharmacology understanding and the proof of scientific expertise (by published scientific research/clinical study articles in peer reviewed scientific journals).
  • You bring along experience in working with regulatory authorities, international medical societies and other relevant international stakeholder.
  • You have sound medical and scientific leadership skills to drive high-priority projects in collaboration with global matrix teams, regional counterparts and external partners.
  • Your agile and effective working style in a fast-paced and changing environment is convincing. Good project management skills and the ability to work in virtual teams as well as fluency in English with very good communication and presentation competencies is part of your profile.

What we offer

  • A modern workplace and exciting opportunities in the development of technologies with a secure future
  • Cross-border intercultural cooperation and short communication channels
  • A collegial corporate culture and flexible working hours enable time management on your own terms
  • Personalized employee development program: specialist and personal training courses provided by our own training academy
  • Diverse corporate benefits with regard to employee health, sport, and staff events

Your application

If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for.

Your contact

Stefanie Eicks
Tel.: +49 2204 8306 3033

Apply now

Miltenyi Biomedicine GmbH
Human Resources
Friedrich-Ebert-Strasse 68
51429 Bergisch Gladbach Germany
www.miltenyibiotec.com/jobs