We are looking to recruit a program director to coordinate and lead Affibody’s development and commercialization of ABY-035 for multiple auto-immune diseases. The location is at our newly established premises in Solna.
In May 2020, Affibody and Inmagene Biopharmaceuticals (Inmagene) announced a strategic partnership to develop and commercialize ABY-035. Inmagene will be responsible for commercialization in mainland China, Hong Kong, Taiwan, and Macau (Greater China), and South Korea, as well as development activities in the Asia Pacific region, excluding Japan. Affibody will retain global commercial rights outside of Greater China and South Korea. The partners will work together to enroll patients into global registrational trials to support Biologics License Applications (BLAs) in multiple indications worldwide.
The role in general
The role is responsible for management and delivery of the integrated development plan, encompassing the strategy for a biologic drug across multiple indications and administration routes, and ensuring alignment across strategic/operational/tactical plans, in support of the overall objectives and priorities of the ABY-035 program.
As program director your main responsibilities include:
- Drive the overall ABY-035 program to key decision points and milestones.
- Lead the generation, update, and alignment of an integrated development plan across functions (e.g. medical sciences, regulatory affairs, clinical development, clinical operations, biostatistics, non-clinical, R&D functional areas, assays, CMC, drug supply management, commercial, etc.) into the overall plan for the program, ensuring alignment between the overall product vision, product profile, strategy, and goals.
- Define the critical path, drive milestone decision point planning and associated deliverables, generate clear decision criteria, and ensure that quality, risk, cost, and time are managed to enable delivery of program milestones and objectives on time and on budget.
- Monitor and report on progress of the program goals. Identify performance issues and recommend appropriate corrective actions.
- Manage an integrated program budget and resource plan and be responsible for the overall program timelines.
- Lead decision analysis within the program, including development and assessment of outcome scenarios and alternative development options to operationally deliver according to plan, robust go/no go decision criteria, probability of technical and regulatory success, value, and investment implications.
- Lead the assessment of program risk (e.g. technical, regulatory, operational) in collaboration with project managers, R&D functional areas, commercial, and other functions. Lead activities to identify contingency and risk mitigation strategies for the program.
- Responsible for development and management of the communication plan for the program, including stakeholder management.
The right candidate fulfills the following qualifications:
- University degree within life science e.g. chemistry/biology, biotechnology, medicine, pharmaceutical sciences, and a minimum of 10 years of experience in the pharmaceutical industry
- Strong track record in executing effective project management of multiple complex projects/programs in cross-functional teams in the biotech/biopharmaceutical industry
- Strong communication/interpersonal skills
- Excellent knowledge of the project management discipline and its application to drug development required to deliver time, cost, quality, and risk management
- Empowering leader who engages others to take ownership to achieve shared goals through teamwork. Must be able to create a highly collaborative and inclusive environment
- Organizational skills
- Knowledge in quality and regulatory requirements
- Excellent verbal and written communication skills in English and ability to communicate in a business environment
We are looking for an energetic, entrepreneurial, team player who thrives in a creative and growing organization. To be successful in the role you need to be highly self-motivated and self-driven. You need to have the ability to collaborate, demonstrating strong team working skills, to establish and maintain good collaboration with different parties, both externally and internally. You have capabilities to coordinate and make long-term plans, to follow through and to handle/mitigate risks/issues as they occur. You provide sound solutions to problems and identify with whom to communicate and interact. The role requires both operational management and strategic oversight. You have the ability make priorities in order to deliver business critical items in time.
We will interview candidates from end of August 2020 and continuously, and welcome your application today!
Please send your application (CV and a note on why you think this is your next step) to firstname.lastname@example.org. Please note that applications will be reviewed and handled from mid-August 2020. If you have any questions about the role, please contact CSO, Fredrik Frejd, at email@example.com.
ABY-035 is a novel bispecific agent, potently targeting both subunits of IL-17A as well as albumin. ABY-035 has been specifically designed to utilize the strengths of Affibody’s technology platform to create a very small protein drug (18 kDa, an eighth of the size of an antibody) with very high apparent affinity to IL-17A (KD ~300fM) and antibody-like half-life due to the strong (KD ~50pM) binding affinity to serum albumin.
Accumulated patient data from ~150 psoriasis patients, some of which have been dosed for more than two years, support a safe and efficacious product profile with best-in-class potential.
In a Phase 1/2 study, ABY-035 demonstrated favorable safety and tolerability across multiple doses and dosing regimens with rapid and sustained efficacy in patients. The primary objective of this study was to evaluate mechanism of action, safety, tolerability and pharmacokinetics of ABY-035.
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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)