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We are looking for a Clinical Project Manager to Affibody, a private clinical-stage Swedish biotech company, focused on developing next generation biopharmaceuticals.The company is expanding its clinical development programs and is therefore recruiting an experienced Project Manager to take on a key role in the design and delivery of Affibody’s global clinical development programs. As Clinical Project Manager you will strive to build development programs that maximizes the potential of Affibody’s compounds.
You will be responsible for the development and execution of Clinical Development Plans, ensuring that the defined Target Product Profile (TPP) is being met. For assigned projects you will lead, and project manage a Clinical Team supporting the overall cross-functional Project Team with clinical deliverables from Phase 1 up to commercialization.
The role will report to the Head of Clinical Development and is located at their premises in Solna, Sweden.
Lead clinical strategic activities, including development of Clinical Development Plans (as an integrated part of the overall Drug Development Plan), clinical trial protocols and report, clinical parts of regulatory documents and key project management plans.
Lead and manage the Clinical Team and ensure delivery of all clinical program activities.
Lead internal and in/outsourced clinical development activities.
Perform continuous sponsor oversight, risk assessment and mitigation on project/program level.
Forecast and manage budget, resources and timelines for clinical programs and ensure that all activities and deliverables are compliant with Affibody SOPs, ICH/GCP guidelines and regulatory requirements.
Manage KOL interactions.
Life science degree with substantial project management experience in pharmaceutical drug development.
Ability to lead multi-disciplinary teams including team building, negotiation and conflict resolution, also involving external parties, like co-development partners and KOLs, delivering results timely.
Preferably experience from early phase to commercialization.
Preferably experience from the Oncology area.
Experience in development of biologicals is a plus.
Experience of budget, resource forecast and management.
Experience with the development of global clinical development plans.
Preferably proven track record of working in small start-ups, biotech companies and in large pharma.
Self-going, creative and solution oriented.
Curious and open to work in an entrepreneurial and growing organization, where ownership and own drive is of greatest importance.
Excellent verbal and written communication skills in English.
I vårt förhållningssätt tillämpar vi inte enbart den grundläggande etiken att inte göra fel utan vi arbetar med vad vi benämner en proaktiv etik, att göra det rätta och att göra gott. Ingen information förmedlas vidare utan uttryckligt godkännande från berörd part.
Haeger & Carlsson Executive Search and Interim söker inte aktivt upp kandidater hos de företag där vi har en etablerad kundrelation.