We are looking for a Global Clinical Program Lead (GCPL) for Oncopeptides. Oncopeptides is a global biotech company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The Company has recently been granted accelerated approval by the U.S. The company, which is listed on the Stockholm Stock Exchange, was founded in Sweden year 2000.
The GCPL will, in partnership with the Global Clinical Lead (GCL), drive effective and quality execution of the allocated clinical program at Oncopeptides. In this role, the GCPL supports the development of the clinical program strategy in compliance with the overall program goals and regulatory requirements. In addition to partnering with the GCL, the GCPL works closely with the Head of Clinical Operation (HoCO), Chief Operating Officer (COO) and clinical development personnel, to ensure delivery as per SOPs, International Conference on Harmonisation-Good Clinical Practice (ICH-GCP), applicable regulations and agreed company goals and values.
- Member of the Clinical Leadership Team (CLT) and Lead the Clinical Program Team (CPT) for allocated product(s).
- Represent clinical development in the Global Product Team (GPT) together with the Global Clinical Lead (GCL).
- Collaborate with GPT members in developing aligned clinical study strategies for country, site and Key Opinion Leader selection and develop clinical program level recruitment feasibility.
- Support Function Heads with resource forecast, management, and follow-up of all clinical program deliverables with regards to time, cost and quality and ensure appropriate risk management.
- Manage the preparation of the clinical part of regulatory authority meeting strategies.
- Contribute to the project publications and abstracts strategy and support Clinical Operations Directors (CODs) with the coordination of publication deliveries.
- Life Science university degree e.g. MSc or BSc.
- Clinical research experience, oncology preferred: 15 years or more of clinical development experience in pharma industry or CRO.
- Excellent understanding of GCP.
- Proven track record of project management, team leadership and working independently.
- Excellent written and verbal skills in English.
Driven by the Oncopeptides Values; Science driven, Patient focused, Entrepreneurial, Collaborative, Passionate, Innovative and Courageous.
Welcome to apply through: www.haegercarlsson.com
Questions are answered by:
Gunilla Haeger +46 (0)70 – 461 93 87, firstname.lastname@example.org or
Anna Wikman +46(0)73-539 33 87, email@example.com