Calluna Pharma AS is seeking an experienced clinical project director/VP Clinical

Calluna Pharma AS is seeking an experienced clinical project director/VP Clinical.

We are looking to strengthen our team with an operational clinical project director with passion for clinical development and extensive experience in clinical trial operations.

As a clinical project director/VP Clinical, you will have a wide range of responsibilities. Primarily, you will be responsible for leading the internal clinical study team, managing external collaborators/partners and oversee the study CROs and clinical service suppliers to achieve successful execution of clinical study(ies) with our lead candidate CAL101 (see further details below).

Job responsibilities:

Contribute to the clinical development and strategic plans of the company, including external expert interactions (i.e., Advisory Boards).

Development or input to required documentation for agreed projects, including the study synopsis, protocol, investigator brochure and regulatory documents.

Provide project oversight and leadership for clinical deliverables:

• Plan and lead execution of the day-to-day activities for the oversight of the clinical trial
• Lead and coordinate the internal clinical study team, collaborators/partners and CROs to ensure success according to time, quality and budget objectives
• Consistently communicate project objectives, expectations and status updates to the internal clinical study team, external collaborators/partners and CRO(s)
• Create and maintain, in collaboration with CROs, ICF, case report form, project specific plans, documents and tools for the study(ies)
• Analysis of data related to site activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develop contingency and mitigation plans to minimize risks; communicate risks & mitigation strategies
• Identify opportunities to improve training, execution and quality control
• Ensure all trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial(s)

To be considered for this role you will meet the following criteria:

• Excellent leadership, team-working and communication skills
• A proven track record of at least 7-10 years in international clinical trial management as clinical study team leader in biotech, CRO or pharmaceutical company
• Experience in managing CROs and other external clinical study stakeholders
• Thorough understanding of GCP/ICH requirements

Location and reporting line

The position is full-time and offer a flexible working arrangement. Flexibility with regards to working hours and travel is required. The position is currently reporting to the SVP Clinical Operation and PV.

Remuneration

Calluna Pharma offers a challenging and exciting role in one of Norway’s most innovative pharmaceutical companies. The company offers a competitive remuneration package including base salary and share options.

Please send your application to renate.birkeli@callunapharma.com as soon as possible.

Contact persons for details about the position:

SVP Clinical Operation and PV Margrethe Sørgaard, T: +47 97019169

VP Clinical Research Sylvia Vetrhus, T: + 47 92201571