Clinical Project Manager

Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals. Affibody is expanding its clinical development programs and is therefore looking to recruit an experienced Clinical Project Manager to take on a key role in the design and delivery of Affibody’s global clinical development programs. The role will report to the Head of Clinical Development and is located at our premises in Solna, Sweden.

The role in general

In the overall strive to build development programs that maximizes the potential of Affibody’s compounds this role will be responsible for the development and execution of Clinical Development Plans, ensuring that the defined Target Product Profile (TPP) is met. For assigned projects the successful candidate 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 requires both operational activities and strategic oversight.

Main responsibilities:

  • Lead clinical strategic activities, including development of Clinical Development Plans (as an integrated part of the overall Drug Development Plan), clinical trial protocols and reports, Investigator’s Brochures, 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 Key Opinion Leader (KOL) interactions.

Qualifications

The right candidate fulfills the following qualifications:

  • Life science degree with substantial project management experience in pharmaceutical drug development.
  • Ability to lead and coordinate multi-disciplinary internal teams to deliver qualitative results in a timely manner, also involving negotiation and conflict resolution.
  • Ability to successfully interact with external parties, like co-development partners and KOLs.
  • Preferably experience from all phases of development from early phase to commercialization.
  • Preferably experience from the Oncology area.
  • Experience in development of biologicals is a plus.
  • Experience of budget and resource forecast and management.
  • Experience with the development of global clinical development plans.
  • Preferably proven track record of working in small start-ups and biotech companies, as well as large pharma.
  • Excellent written and oral communication skills in English.
  • Preferably oral communication skills in Swedish.

Personal attributes

At Affibody we keep coming back to our values Caring, Ambitious and Goal-oriented. To be successful in this role, while also enjoying our organization, we are looking for an entrepreneurial team player who thrives in a creative and growing organization where the landscape keeps changing while we have our eyes set on our long-term goals.

In this role, you need to be highly self-driven and goal-oriented, demonstrating strong team leadership skills and having the ability to establish and maintain good collaborations with different parties, both externally and internally. We further believe you have capabilities to coordinate and make long-term plans, to follow through and to handle/mitigate risks/issues as they occur. You have the ability to prioritize in order to deliver business critical items in time and you demonstrate ownership, providing sound solutions to problems and identifying with whom to communicate and interact.

Application

In this recruitment we are collaborating with Haeger & Carlsson. Welcome to apply through this link.

Questions answered by Gunilla Haeger 070-461 93 87, gunilla@haegercarlsson.com or Anna Wikman 073-539 33 87, anna@haegercarlsson.com

Affibody in short

Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.

Upcoming reports Financial calendar

  • Interim Report January to March 2020 (May 15, 2020)
  • Interim Report January to June 2020 (August 21, 2020)
  • Interim Report January to September 2020 (November 13, 2020)
  • Year End Report 2020 (February 2021)