Associate Director/Director Preclinical Development - Affibody
The Associate Director/Director Preclinical Development will manage preclinical project activities to successful and timely delivery from internal process- and assay development, via outsourcing to contract manufacturing organizations and contract research organizations for IND enabling studies up to the regulatory documentation needed for the clinical translation of Affibody projects.
The role will be part of the Development team, and will be directed by the objectives and demands of the preclinical and clinical projects, including planning, hands-on work, and follow-up of preclinical development activities to execute on project/company goals within budgets and timelines.
Key Responsibility Areas
- Responsible and accountable for planning, directing, monitoring and coordinating preclinical activities within specified timelines
- Quality responsibility and influence authority within assigned projects
- Delegate tasks and receive reporting from different parts of the company and from external parties and contract organizations
- Keep up to date within the preclinical development area, including new guidelines for production and safety assessment of biologics
- Hands on work with regulatory documents needed for the preclinical parts in IND/CTA submissions
- Present continuous and clear recommendations to the research management team
An advanced degree in Life Sciences
- Several years of relevant experience from pharmaceutical development, including leading and managing IND enabling activities in preclinical projects
- Extensive experience from project management and coordination of out-sourced activities within the biotech/pharmaceutical industry
- Strong interest in science and keeping up to date with the development of the industry, coupled to an analytical mind and ability to translate and integrate new information to novel and strategic thinking in the internal drug development process
- Experience from manufacturing of biologics is an advantage
- Experience from safety assessment of biologics is an advantage
- Experience from hands-on work with regulatory documents needed for the preclinical part in IND/CTA submissions is an advantage
Skills and abilities
- Good English writing
- Ability to work independently as well as in cross-functional teams
- Result oriented and self-motivated
- High organizational skills and good coordination skills
- Good skills in communication and documentation in English
- Proficiency in the Swedish language (oral and written) is an advantage
Application and more information
You are welcome with your application by e-mailing your CV and a personal letter to firstname.lastname@example.org as soon as possible. We are working continuously with this recruitment project. Write “Preclinical Development” in the subject field. Please call Knut Natt och Dag on +46 722 166 800 if you have any questions.
Affibody is a clinical stage Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.
The company operates a focused experimental medicines model and currently has four clinical or late stage preclinical proprietary programs. The first three are therapeutic programs that targets psoriasis, B-cell driven autoimmune diseases, and liver diseases respectively. The fourth program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.
In addition to its portfolio of innovative drug projects the company offers the half-life extension technology, Albumod™, for outlicensing.
Affibody has ongoing commercial relationships with several companies such as AbClon, Biotest, Daewoong, Daiichi Sankyo, GE Healthcare, and Swedish Orphan Biovitrum.
Affibody is cooperating with Aktivia Science Work in this recruitment. Aktivia Science Work is a recruiting and consulting company within Life Sciences specialized in positions within the pharmaceutical industry – from early discovery through pharmaceutical development and clinical development to the market place. We are members of SwedenBIO and Medicon Valley Alliance.