Clinical Program Head - Basel, Deutschland - Ariceum Therapeutics GmbH

Ariceum Therapeutics GmbH
Ariceum Therapeutics GmbH
Geprüftes Unternehmen
Basel, Deutschland

vor 3 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung
Clinical Program Head
Ariceum Therapeutics GmbH is a rapidly growing clinical stage oncology company focused
on developing next generation radiopharmaceutical oncology products. The product pipeline
includes satoreotide, a potent antagonist with high affinity for tumour cells expressing SST2
receptors. Satoreotide is being developed into products with complementary therapeutic and
diagnostic imaging opportunities in a range of solid tumours. Ariceum Therapeutics GmbH is
headquartered in Berlin with a subsidiary in Basel and employees in a number of European
countries.

Position

Job title:
Clinical Program Head


Department/Function:
Research and Development

Reports to:
Head of R&D / Head of Clinical Development
Number of reports 0-2 direct reports, matrix management of cross-functional teams
Financial responsibility N.A.

Location of the role:
Basel (office based with hybrid component)

Main Purpose of the Position

The Clinical Program Head

  • Leads the strategy, scientific design, planning and management of the assigned
development programs

  • Develops close working relations with medical experts and investigators in the
relevant disease area(s) and represents Ariceum Therapeutics in scientific and
regulatory meetings

  • Oversees resource allocation and budget for the assigned programs
  • Actively contributes to build an empowered organization that can adjust quickly to
business needs.

  • Key Responsibilities and Tasks
  • Accountable for clinical leadership and clinical program strategy
  • Accountable for clinical deliverables with high quality, within agreed time and budget
  • Accountable for clinical documents (e.g., Study Protocols, Investigators' Brochure,
safety related documents, study reports), clinical components of regulatory
documents, clinical communication and publications

  • Accountable for Patient Safety of the assigned compounds, including signal detection
and surveillance

  • Responsible for resource planning and management for the assigned clinical
programs in close collaboration with finance, program management and other
functions

  • Accountable for process development and implementation in compliance with
ICH/GCP and other relevant standards

  • Responsible for medical and scientific leadership in interactions with external and
internal stakeholders (e.g., regulatory authorities, key opinion leaders, advisory
boards, patient advocacy groups)

  • Responsible to identify risks and mitigation strategies including contingencies
  • Contribute to the overall strategy and scenario generation for the R&D portfolio,
support the Head of R&D to align the organization behind agreed strategy

  • Experience / Professional equirements:
  • MD required. Advanced knowledge in relevant disease area(s) required
  • 6 years of involvement in clinical drug development, including demonstrated
leadership and accomplishment in designing and conducting clinical trials (e.g.,
planning, executing, reporting and publishing)

  • People management experience required, including matrix management


  • Required Competencies

  • Ability to leverage scientific, clinical and technical knowledge with excellent

- communication skills
  • Strategic thinker with strong influencing and negotiation skills, regulatory experience

- would be advantageous
  • Excellent organizational skills
  • Proven knowledge of Good Clinical Practice, clinical trial design and drug

- development process
  • Working knowledge of oncology
- and nuclear medicine-specific aspects of clinical
- development desired
  • Ability to travel internationally (anticipated requirement: 20% of the time)
  • Fluent English (oral and written)
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