Director Clinical Development - Frankfurt am Main, Deutschland - ProClinical

ProClinical

Geprüftes Unternehmen

Frankfurt am Main, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Salary:

Highly Competitive

Job type:

PermanentDiscipline:

Director, VP & Physician
Location:
Germany- Frankfurt, Germany

Posting date: 22 Feb 2024

Reference:
59077

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.
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 immunooncology.
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 latestage 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 crossfunctionally.
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.

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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