Participate in the design and execution of clinical trials of their assigned programs
Collaborate with the (Senior) Director Clinical Development to drive clinical strategies
Manage day-to-day clinical activities for our clinical studies
Assume Trial Lead responsibilities in the assigned programs
Create and translate Target Product Profile into clinical strategy
Collaborate closely with Pharmacovigilance on development of Risk Management Plans
Support preparation and participate in study level meetings
Contribute to a collaborative culture within and outside Clinical Development.

Master degree with strong scientific and clinical background in Immuno-Oncology, Oncology
Minimum of 3 years of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and the academic setting
Total 5 years’ experience in related area
Good understanding of the clinical and scientific methods and approaches used in clinical development studies
Several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities
Experienced in global health authority interactions (EMA, FDA, MHRA, CDE)
Strong medical experience in medical monitoring including overseeing and interpreting safety and efficacy clinical trial data
Ability to strategize clinical activities based on a TPP and CDP and translate into trial designs
Ability to write high quality and executable trial designs and protocols
High level of comfort and demonstrated successes working in a matrix environment (global and cross-functional)
Subject matter expertise on drug development topics and genuine interest to drive innovation and continuous improvement
High proficiency in English (written and spoken).

Senior Manager, Clinical Development

Key skills