(Senior-) Director* Clinical Development - Germany Based

Proclinical are in partnership with a biotech organisation to join their team. This role is on a permanent basis. For more information, please get in touch now!

Responsibilities:

• For this role, you will be responsible for forming, guiding and handling relationships with crucial external shareholders such as industry partners, KOLs, health authorities.
• In this position, you will work alongside the VP of clinical development to steer clinical methods and their operationalisation of portfolios and platforms.
• Responsible for oversight of the clinical study report medical content meets high quality expectations on medical standards, offering respective direction to any other members of the clinical development team.
• As the Clinical Development Director, you will monitor the ongoing medical data evaluation.
• Serve as a representative of the team to decision/governance meetings, senior management, or advisory boards when suitable.
• The ideal candidate will produce and translate target product profile into clinical method.
• Work on programs with various studies, assume matrix line management and train clinicians accountable for said studies.
• Other duties as assigned.

Key Skills and Requirements:

• Educated to an advanced degree level with a scientific and clinical background in oncology or immuno-oncology.
• Prior involvement with being constantly involved in clinical trials from beginning to end.
• Acquaintance in international health authority interactions such as EMA, FDA, CDE, etc., as well as contributed or led a drug development program to successful registration would be beneficial.
• Familiarity within monitoring and comprehending safety and effectiveness of clinical trial data and guaranteeing suitable contact for study medical and patient safety aspects.
• Leadership experience and abilities.
• Demonstrable experience within either Immuno-Oncology, ADCs, Cell Therapy or Individualized Cancer Vaccines at the biotech/pharmaceutical and the academic setting, which involves leading clinical development programs from exploratory Phase I/II clinical studies through late-stage development in Phase III and NDA/BLA submission.
• Knowledge in clinical development studies in pharmaceutical/biotech organisation, which involves innovative study design, companion diagnostics, clinical pharmacology, translational modelling, biostatistics, and Phase 3 trial design, with significant experience in dossier preparation and proposals.
• Capable of working within a matrix setting.
• Works well cross-functionally.
• Keen on and comprehension of the science assisting the clinical development programs.
• Confidence in presenting.
• Fluency in the English language.
• Communication skills both verbally and in writing.

If you are having difficulty in applying or if you have any questions, please contact Kain Rix at k.rix@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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