Akthelia Pharmaceuticals

Akthelia Pharmaceuticals is an early-stage biotech startup working on breakthrough technology to improve oncology outcomes through immunomodulation. Akthelia´s lead compound (AKT-011 Febrile Neutropenia) is entering IND enabling studies with the main objective to start a Phase 1a clinical study in 2025. We have just raised funding to ready ourselves for IND-enabling studies in Q4 of this year and were very recently jointly awarded a $6.6M EU Horizon grant, which is highly competitive and serves as a strong validation of the strength that others see in our approach.

Vinnustaðurinn

Pharmaceutical drug development

Akthelia is looking for an R&D Manager. Our lead AKT-011 programme, a small molecule, orally available NCE, is targeting the very large opportunity to improve outcomes in cancer chemotherapy and we have IP around a broad class of compound with potential application to many areas of medicine with high unmet need. Our approach is to upregulate the innate immunology of epithelial surfaces. The AKT-011 is at late preclinical stage, we plan to start human studies in 2026.

Helstu verkefni og ábyrgð

Develop and manage project timelines, budgets, and resources, and report project status to internal parties (executive team, board of directors) and external parties incl third party providers.
Establish and maintain relationships with CROs and other external partners to ensure timely and high-quality delivery of preclinical and clinical development activities.
Identify and manage project risks and develop mitigation strategies to ensure that project objectives are achieved.
Monitor compliance with regulatory requirements and guidelines for IND preparation.
Coordinate and lead project team meetings to ensure alignment and effective communication among team members.
Oversee the preparation and submission of the IND package to the regulatory authorities.
Identify grant funding opportunities and write up compelling proposals and statement of work, submit and manage grant proposals, and furnish prospective funders with supporting documents.

Menntunar- og hæfniskröfur

Graduate or higher studies in a relevant scientific or medical field.
Good project management skills, with the ability to develop and manage a project timeline within budget.
Preferable:
- 1-3 years of experience in clinical development and medical affairs in the biotech or pharmaceutical industry.
- Good understanding of preclinical and clinical development and medical affairs, including study design, execution, and reporting, FDA, EMA and ICH guidelines and regulations.
- Ability to identify and manage clinical development and medical affairs risks.
- Knowledge of CMC and drug development.