Clinical Operations Program Director - Biotech

Highly Competitive
  1. Permanent
  2. Program Manager / Director
  3. Belgium
Brussels, België
Posting date: 28 Mar 2024

Proclinical are representing a medium sized, global biotech who are expanding rapidly due the significant products that are coming through in our clients pipeline. As a result, they're seeking several Clinical Operations Program Directors to strengthen our clients Global Clinical Trial Operations team. The Clinical Operations Program Directors is responsible for the oversight of clinical-related activities within a specific therapeutic indication for an asset or across all indications for an asset. The Clinical Operations Program Directors co-leads the Clinical Development department and co-owns the Clinical Development Plan. This role is crucial in driving the execution of the clinical program in collaboration with the Clinical Development department.

Key Responsibilities:
- Accountable for all clinical-related aspects within the assigned therapeutic indication/program.
- Create the CDP in collaboration with the Medical Development Lead, Project Manager and other Clinical Development representatives.
- Act as primary point of contact for all clinical-related activities for a given indication or across asset indications.
- Lead the Clinical Development meetings, supported by the PM.
- Ensure that clinical trials are executed according to the CDP, following the company procedures and processes and conducted in compliance with ICH-GCP and other applicable legislation.
- Identify risks of missing team goals, timelines or spend expectations, ensure that these are reflected in applicable risk registries and drive their mitigation.
- Oversee the clinical trial budgets, contribute to timeline and resource requirements and inform the PM in case the timelines or budget deviate from projected.
- Support continuous improvement processes and consistency.
- Act as line manager of Clinical Trial Managers (CTMs) and/or Clinical Trial Associates (CTAs).

- Experience with overseeing FiH programs through to commercial (Phase I-IV)
- BSc or MSc. PhD degree is a plus.
- Minimum of 10 years of leading experience in Clinical Development/ Operations within a biotech/ pharma
- Experience in working in an outsourced model, including overseeing CROs and vendors.
- Strong interpersonal and stakeholder management skills.
- Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry.
- Strong organisational skills, able to manage multiple and varied tasks and prioritize workload.
- Strong verbal and written English communication skills.
- Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines.
- Rare diseases experience would be a plus.

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