AC Immune SA

Description Function Clinical Project Manager (CPM) Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne E-Mail schreiben Percentage 100 % Reporting Line Head of Clinical Operations (HCO) Company Profile AC Immune is a clinical stage Swiss biotech company focused on the development of innovative therapeutics and diagnostics for Alzheimer's and other neurodegenerative diseases 150+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ AC Immune SA is a progressive, equal opportunity employer Job description The Clinical Project Manager will be responsible, under the supervision of the Head of Clinical Operations, of the management of regional and/or international studies, alone or in collaboration with a senior CPM, according to time, cost and quality standards. Key Responsibilities Manage international clinical studies according to time, cost and quality standards Negotiate, implement and maintain contracts with study partners (study vendors, sites) Manage activities of study partners, support clinical CRO in managing the sites Review and approve submission packages for submission to Ethics Committees/Institutional Review Boards Supply proper documentation to the Regulatory department for submission to Regulatory Authorities Contribute to the generation of SOPs/WIs Participate in clinical study design Create and maintain operational plans Prepare study budgeting and forecasting Global budget management of studies Ensure the accurate planning and ordering of clinical study drug supply Lead study protocol development Write and update clinical study documents Participate to review and approval of the Clinical Trial Report Be responsible for the Trial Master File Participate in study specific core team meetings Qualifications & Skills Required: A scientific degree is required as well as the ability to work in a start-up environment, handling multiple demands and strong planning and organizational skills Minimum of 4 years of experience in clinical research (preferably with 2 years coordinating international or leading regional studies) Knowledge in international standards (GCP/ICH) as well as in international (FDA/EMA) and local regulations Hands on experience in writing clinical study documents Good spoken and written English Personal features include: Advanced understanding of timelines, budget and resource management Planning, tracking and solving skills for maintaining project timelines Networking skills Working both independently and in a cross-functional team setting

Intern - a-Synuclein Biology Description Function Intern Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne E-Mail schreiben Percentage 100 % - 6 months internship Reporting Line Senior Scientist in the a-Synuclein Biology team. Company Profile AC Immune is a clinical stage Swiss biotech company focused on the development of innovative therapeutics and diagnostics for Alzheimer's and other neurodegenerative diseases 150+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ AC Immune SA is a progressive, equal opportunity employer Job description AC Immune is seeking a trainee in the Biology group within AC Immune's R&D team, working on Discovery and characterization of therapeutic small molecules and biologicals for neurodegenerative disorders. The candidate must possess scientific background in biochemistry, cell biology or neuroscience. The candidate must have demonstrated ability in performing protein-based assays and in maintaining an excellent record of protocols and experiments in laboratory notebooks. Key Responsibilities Evaluate compounds' efficacy in established biochemical and cellular assays of alpha-synuclein aggregation Contribute to the development of new assays aiming at investigating the mode of action of therapeutic molecules Perform immunoassays for protein detection in cells, mouse and human brain tissues Participate to the development of a predictive machine learning model Acquire images by fluorescence or brightfield microscopy and perform image analysis Participate to the preparation of small molecules' stocks Analyze, document and present scientific data Qualifications & Skills The candidate should have the following qualifications: BSc, MSc, or Engineering degree in biochemistry, molecular biology, neuroscience or similar discipline Experience in laboratory work and in maintaining record of protocols and experiments in electronic laboratory notebooks is a plus Basic programming (Python) and image processing (ImageJ) knowledge is an advantage Excellent capabilities in work organization and data documentation Team player paired with autonomous, organized and careful work style Good spoken and written English are required

Clinical Lead Description Function Clinical Lead Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne E-Mail schreiben Percentage 100 % Reporting Line Head of Clinical Development Company Profile AC Immune is a clinical stage Swiss biotech company focused on the development of innovative therapeutics and diagnostics for Alzheimer's and other neurodegenerative diseases 150+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ AC Immune SA (ACIU) is a progressive, equal opportunity employer Job description The Clinical Lead takes responsibility to lead the clinical development activities of one or more clinical programs. Current clinical programs focus on neurodegenerative diseases (eg., Alzheimer's disease, Parkinson disease). She/He develops clinical development plans and clinical project strategy, including a translational biomarker strategy. The Clinical Lead participates notably to the clinical study team and core team, representing the clinical development. As a key contributor she/he takes responsibility for developing study plans and protocols according to the agreed company's strategy. She/He is also responsible for implementing the clinical and biomarker development strategy notably based on data from the competitive landscape and from the most recent state of the art, medical and scientific knowledge. She/He takes part in and supervises all the key steps related to the preparation, the conduct and the completion of the clinical studies, including the medical and safety monitoring, associated to the related clinical program sponsored by ACIU. She/He also provides appropriate support to the clinical operations team and other key stakeholders. Key Responsibilities Lead the direction, planning, execution and interpretation of assigned clinical trials, with a focus in neurodegenerative diseases. Take part in the elaboration of clinical strategy and clinical communication, with a leading role in neurodegenerative diseases. Lead the development of the assigned clinical development program and 5-year clinical plans in alignment with ACIU strategy. Ensure/supervise the interpretation of the data from internal clinical trials and from competitors. Establish/review clinical study designs and implement clinical protocols, data collection systems and final clinical study reports. Supervise, in respect to GCP, adherence to protocols and to clinical reports including medical/safety aspects. Supervise/take part in the medical and safety monitoring and reports promptly serious adverse events or any safety concerns considered of medical significance according to internal SOPs. Take part in the DSMB blinded meetings. Prepare/take part in investigator's meetings. Generate presentations, publications and interfaces with KOLs, external experts, advisory boards, and health authorities. Provide medical support to due diligence associated with in-licensing, acquisitions, and co-development agreements, under supervision of the head of clinical development and the CMO. Clinical Lead Ensure/handle clinical interfaces with external partners. Ensure competitive intelligence in the related field in order to implement a state-of-the-art approach for the related clinical development program and clinical studies. Supervise/provide support on the preparation, the review and the finalization of key clinical documents including, but not limited to, clinical development plan, clinical protocols and related amendments, clinical study reports, investigator's brochures, DSURs, and other key study documents as appropriate. Provide support to the clinical operation team and other stakeholders as needed. Qualifications & Skills Required: MD or MD/PhD with board certification in neurology or psychiatry or both 8+ years of pharma/biotech R&D experience. Strong experience in earlystage drug development is essential, preferably in the field of Parkinson disease and motor diseases Health Authority Interaction experience, e.g. with FDA and EMA Strong interpersonal skills: Outstanding interpersonal, verbal, and written communication (English) and influencing skills Proven ability to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties Able to establish seamless collaboration with colleagues/other parts of the organization

Trainee Description Function Trainee Location / Contact AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne E-Mail schreiben Percentage 100 % - 6 months internship Reporting Line Research Scientist - TDP-43/Neuroinflammation Team Company Profile - AC Immune is a clinical stage Swiss biotech company focused on the development of innovative therapeutics and diagnostics for Alzheimer's and other neurodegenerative diseases 150+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ AC Immune SA is a progressive, equal opportunity employer Job description AC Immune's R&D team is seeking a highly motivated trainee to support the discovery and development of new drugs for the treatment of neurodegenerative and inflammatory diseases. The candidate will be involved in developing and performing in vitro assays and must keep an excellent record of protocols and experiments in laboratory notebooks. Key Responsibilities Develop and execute in vitro assays in cell lines, primary microglial and neuronal cells, to evaluate the efficacy and explore the mechanism of action of novel compounds Implement with supervision the assay development steps Interpret and process raw data to draw conclusions from the experiment, getting familiar with Excel and Prism calculations and data recording in the electronic lab book Participate to general laboratory organization by ensuring availability of reagents necessary for the experiments Present results to the team Qualifications & Skills Required: Last year of a master's/engineer degree in cellular biology, biochemistry, immunology, neuroscience or similar discipline Experience in a laboratory environment Cell-based assays, ELISA or other immunoassays, and capillary electrophoresis/Western Blot would be an advantage Personal features include: High degree of autonomy and will to learn Positive team spirit Demonstrated ability to synthesize, analyze and communicate key information Excellent capabilities in work organization and data documentation Flexibility and creativity Good spoken and written English