Allakos Management

Dr Alexander has held leadership positions in biotechnology and has been involved in the formation and management of numerous biotechnology companies. Robert was CEO of ZS Pharma where he led the initial public offering and sale of ZS Pharma to AstraZeneca. Prior to ZS Pharma, Robert was a Director at Alta Partners, a venture capital firm and was also Executive Chairman and interim CEO of SARcode Bioscience. During his time at Alta Partners, he led investments in SARcode Bioscience (acquired by Shire), Lumena Pharmaceuticals (acquired by Shire), ZS Pharma (acquired by AstraZeneca), and Allakos. Prior to Alta Partners, Robert was a Principal in MPM Capital’s BioEquities Fund. Robert joined MPM from Genentech, where he worked in the Business Development group. He holds a PhD in immunology from the University of North Carolina at Chapel Hill and a bachelor’s degree in zoology from Miami University of Ohio.

Prior to joining Allakos, Dr. Tomasi was Chief Scientific Officer and Head of Corporate Development at ZS Pharma where he led scientific, business development, and investor relation functions through the company’s initial public offering and sale to AstraZeneca. Before joining ZS Pharma, Dr. Tomasi was a Principal at Alta Partners where he contributed to investments in ZS Pharma (acquired by AstraZeneca), Lumena Pharmaceuticals (acquired by Shire), Excaliard (acquired by Pfizer), ChemGenex (acquired by Cephalon), Achaogen, Immune Design and Allakos. Dr. Tomasi served as a drug discovery scientist with Gilead Sciences and Cytokinetics. He holds an M.B.A. from the Harvard-MIT Biomedical Enterprise Program, a bachelor’s degree in chemistry from the University of California, Berkeley and a Ph.D. in chemistry from the University of California, Irvine.

Dr Rasmussen has more than 25 years of experience in the pharmaceutical and biotech industries. Henrik has led numerous global development programs and regulatory filings worldwide, including INDs, clinical trial applications (CTAs), NDAs, supplemental new drug applications (sNDAs), biologic license applications (BLAs), and MMA filings. He has published over 150 peer-reviewed papers in the therapeutic areas of nephrology, cardiology, ophthalmology, gastroenterology and diabetes.

Most recently, Dr. Rasmussen was the Chief Medical Officer at ZS Pharma for which he worked from 2010 to 2016. Prior to joining ZS Pharma, he was the President and CEO of Rasmussen Biotech & Pharma Consulting. Dr. Rasmussen has held the positions of Corporate Vice President, Head of Clinical Development, Medical & Regulatory Affairs at Novo Nordisk, and Chief Medical Officer, for Nabi Biopharmaceuticals and GenVec. He was the Senior Vice President for Clinical Research and Regulatory Affairs at British Biotech and Global Study Director for Cardiovascular Drug Development at Pfizer Central Research.

Dr. Rasmussen received his MD and PhD from the University of Copenhagen, Denmark, and is trained in internal medicine and cardiology.

Dr Bebbington is a co-founder of Allakos.

He has more than 25 years experience in the biopharmaceutical industry. He held various scientific and leadership roles at Celltech Ltd, including Head of Mammalian Expression and Team leader in Immunomodulation. During this time, he developed expression systems for recombinant antibodies, including the GS-System™, currently used in the manufacture of several approved antibody products, and conducted research into T-cell activation and chimeric antigen receptors. He was Director of Molecular Immunology at Coulter Pharmaceutical Inc., Senior Director of Research at Corixa Corp. and led a team that transferred to Medarex Inc on the acquisition by Medarex of antibody-drug conjugate technology and assets from Corixa. In 2003, Dr Bebbington was a co-founder of Celscia Therapeutics, a therapeutic antibody development company which merged in 2004 to form KaloBios Pharmaceuticals Inc. At KaloBios he was Vice President of Research, leading a team that developed a novel antibody humanization technology, “Antibody Humaneering™”, outlicensed to multiple partners, and entered 4 antibodies into clinical trials. He co-founded Allakos in 2012.

He has a Bachelor of Arts in Natural Science from the University of Oxford, U.K. and a Master of Arts and Doctor of Philosophy also from the University of Oxford.

Has over 20 years of experience in the heathcare industry. Prior to joining Allakos, Dr Greenwood was Investment Director for the Roche Venture Fund, where he led investments in 23andMe, Allakos, Biodesy, CytomX (NASDQ: CYMX), DVS (acquired by Fluidigm), Epic Sciences, Horizon Discovery (AIM: HZD), Maculogix, ProActa and Stratos. Prior to his role at the Roche Venture Fund, Dr. Greenwood was the head of GenenFund, Genentech's corporate venture fund, and he also held roles in research and business development at Genentech. Dr. Greenwood holds a Ph.D. in Genetics and Development from Columbia University College of Physicians and Surgeons, where he was a Fulbright Scholar.

Dr Tomasevic is a co-founder of Allakos.

He received a Bachelor of Science degree in Chemistry from the University of Belgrade in Yugoslavia and a Master of Science and Ph.D. in Biochemistry at the same university. He completed postdoctoral training at National Institutes of Health (NIDDK, Genetics and Biochemistry Branch) in Bethesda, Maryland in the laboratory of Dr. Brenda Peculis. During the training, he discovered 2 previously uncharacterized proteins. After that, he joined Cytokinetics leading a team that identified small molecule inhibitors of key players involved in actin dynamics i.e. cell motility. The data have been published in prestigious scientific journals. At Nuvelo, he led a protein biochemistry group that accomplished numerous preclinical studies on protein and antibody therapeutics. He was director of Protein biochemistry at KaloBios and his team supported preclinical and clinical activities for 3 clinical-stage antibodies. During this time, he was a team leader for an antibody program in allergy. He co-founded Allakos in 2012.

Received a Bachelor of Science in Biochemistry from Brown University and a PhD in Biological Chemistry from the Hershey Medical Center of Penn State University. She had a post-doctorate appointment at MIT in the Applied Biological Science and was an Assistant Research Professor at Mt. Sinai Medical Center in New York City studying glycoprotein synthesis. She has more than 25 years experience in the biopharmaceutical industry. She held various scientific and leadership roles at Centocor, Inc, including Executive Director for Regulatory Affairs. While at Centocor, she was responsible for preclinical, clinical and manufacturing strategy and submissions for INDs and Marketing Applications for cardiovascular, immunology, oncology and infectious disease products. She joined Human Genome Sciences, Inc. in 2000 and served as the Senior Vice President of Development and Regulatory Affairs with responsibility for formulation and implementation of global regulatory and drug development strategies. She has secured approval for five first-in-class biologics, initiated INDs for over 50 indications, and submitted over 6 BLAs for products including murine, chimeric and human antibodies; radioconjugates; antibody fragments; and fusion proteins. From 2013 until joining Allakos, she was an independent biopharmaceutical consultant.

Dan Janney joined Alta Partners at its founding and is a Managing Director. He has over 20 years of successful early stage investing experience in life sciences. Dan’s focus on working with talented entrepreneurs to create companies around novel insights in biology and new approaches to drug discovery has led to the funding and development of 32 companies. Prior to Alta, Dan was a senior investment banker at Montgomery Securities where he advised life science companies on over $8 billion of equity and merger transactions.

Dan is currently on the board of directors of several public and private companies, including Esperion Therapeutics (NASDAQ:ESPR), Evolve Biosystems, Prolacta Bioscience, Sutro Biopharma, and Viveve (OTC:VIVMF). In addition, he led Alta’s investments in Astex Pharmaceuticals (acquired by Supergen), Cellective (acquired by Medimmune), ChemGenex (ASX:CXS acquired by Cephalon), CoTherix (NASDAQ: CTRX acquired by Actellion), Definity Health (acquired by United Health), Dynavax (NASDAQ:DVAX), Endonetics (acquired by Medtronic), Ilex Oncology (NASDAQ:ILXO acquired by Millennium Pharmaceuticals), InterMune (NASDAQ:ITMN acquired by Roche), LJL Biosystems (NASDAQ:LJLB acquired by Molecular Devices), Mako Surgical (NASDAQ:MAKO acquired by Stryker) and Triangle Pharmaceuticals (NASDAQ:VIRS acquired by Gilead).

In 2006 and 2007, Dan was listed in Forbes’ Midas 100 List of Top Tech Investors. He is a member of The President's Council of the J. David Gladstone Institutes and serves on the Board of Regents of Georgetown University. He holds a B.A. from Georgetown University and a Master of Business Administration from the Anderson School at the University of California, Los Angeles.

Dr Alexander has held leadership positions in biotechnology and has been involved in the formation and management of numerous biotechnology companies. Robert was CEO of ZS Pharma where he led the initial public offering and sale of ZS Pharma to AstraZeneca. Prior to ZS Pharma, Robert was a Director at Alta Partners, a venture capital firm and was also Executive Chairman and interim CEO of SARcode Bioscience. During his time at Alta Partners, he led investments in SARcode Bioscience (acquired by Shire), Lumena Pharmaceuticals (acquired by Shire), ZS Pharma (acquired by AstraZeneca), and Allakos. Prior to Alta Partners, Robert was a Principal in MPM Capital’s BioEquities Fund. Robert joined MPM from Genentech, where he worked in the Business Development group. He holds a PhD in immunology from the University of North Carolina at Chapel Hill and a bachelor’s degree in zoology from Miami University of Ohio.

Has 25 years of life sciences experience and has been involved in the formation and management of numerous biotechnology companies. He is currently Executive Chairman and Chief Executive Officer of Precision Immune, Inc., and was the President, CEO, and Director of Labrys Biologics, Inc. from December 2012 until it was acquired by Teva Pharmaceuticals in July 2014. Prior to joining Labrys, Steve was President, CEO and Director of KAI Pharmaceuticals, Inc. from October 2004 until the company was acquired by Amgen in July 2012. His previous positions have included Senior Vice President of Commercial Operations at Exelixis; Chief Business Officer at Sunesis Pharmaceuticals and VP of Business Development at Isis Pharmaceuticals (now Ionis). He began his career in new product planning at Eli Lilly. He holds a Masters in Management from the Kellogg School of Northwestern University and an undergraduate degree from Brown University. Steve is Chairman of Antiva Biosciences, and a director of Ocera Therapeutics, Chrono Therapeutics, and Cascadian Therapeutics (formerly, Oncothyrean, Inc).

Joined RiverVest in April 2008 as a Venture Partner and became a Managing Director in April 2011. He has over 25 years experience as a successful "drug hunter and developer" in both large and small biopharma, including a decade in small-cap and venture-backed companies. John serves on the board of Otonomy Inc., Lumena Pharmaceuticals, Inc., Allakos and ZS Pharma, all RiverVest Fund II portfolio companies. Prior to joining RiverVest, he was president and CEO of Kalypsys, Inc., and has served on the boards of IDM Pharma, Inc. (acquired by Takeda), Epimmune and Keel Pharmaceuticals, Inc. John holds more than 50 patents and numerous patent applications, primarily in the areas of cancer treatment and inflammatory disease. John worked as a scientist with Searle / Pharmacia, from 1987-2003, including head of discovery research from 1997-2003. Through his efforts, John helped establish the groundwork for new studies that led to the commercialization of several major products, including DayPro, Arthrotec, and most notably, Celebrex, one of the leading pharmaceuticals to treat arthritis. Prior to 1987, John was a senior scientist at E.I. DuPont de Nemours and Company; a member of the Basel Institute for Immunology in Basel, Switzerland; and a research associate in the Department of Microbiology and Immunology at Washington University in St. Louis. Additionally, he has co-authored more than 70 published, peer-reviewed scientific papers. John completed his Ph.D. in immunology from the University of Chicago and his B.S. in biology from Northern Illinois University.

Has served as an observer on our board of directors since December 2015. Ms. Nuechterlein joined F. Hoffmann-La Roche Ltd. in 2002 and currently serves as a deputy director and head of the Roche Venture Fund. Prior to that, Ms. Nuechterlein served as general counsel for SangStat, Inc. She currently serves on the board of directors for AveXis Inc and Lysosomal Therapeutics Inc and as an observer at Allakos and Epic Sciences. Ms. Nuechterlein holds a B.A. from Valparaiso University and a J.D. from University of Michigan.


Dr Bochner is a co-founder of Allakos.

He received a Bachelor of Arts degree with honors in Natural Sciences from the Johns Hopkins University in Baltimore, Maryland and attended medical school at the University of Illinois College of Medicine in Chicago, where he again graduated with honors. After completing Internal Medicine residency training at the same institution, he began his postdoctoral allergy and immunology training in the laboratory of Dr. Robert Schleimer at Johns Hopkins in the Division of Allergy and Clinical Immunology of the Department of Medicine. In 1988 he joined the faculty at Johns Hopkins. He is board-certified in both internal medicine and allergy and immunology.

In August 2013, Dr. Bochner became the Samuel M. Feinberg Professor of Medicine in the Division of Allergy-Immunology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois. Prior to this, he was Professor of Medicine in the Division of Allergy & Clinical Immunology and a Cosner Scholar in Translational Research at the Johns Hopkins University School of Medicine in Baltimore, Maryland. From 2003-2013 he was the Division Director. He has received several awards including the David M. Levine Excellence in Mentoring Award from the Department of Medicine at Johns Hopkins. Dr. Bochner is a Fellow of the American Academy of Allergy Asthma and Immunology and the American College of Allergy Asthma and Immunology. He is a member of the American Society for Clinical Investigation, the Association of American Physicians, President-Elect of the International Eosinophil Society and Vice President of the Collegium Internationale Allergologicum. He was Associate Editor for the Journal of Allergy and Clinical Immunology from 1993-2013, and remains co-Editor-in-Chief for the Allergy and Immunology Section of the online resource UpToDate and an editor of the Middleton's Allergy: Principles and Practice textbook among others. He previously served on the Board of Directors of the American Board of Allergy and Immunology and the Board of Directors for the American Academy of Allergy Asthma and Immunology. He is currently a member of the Hypersensitivity, Autoimmune, and Immune-mediated [HAI] Diseases Study Section. He is the author of more than 250 peer-reviewed publications, reviews, and book chapters, with an interest in the mechanisms of allergic cell recruitment, activation and survival in human allergic inflammatory responses. He sees patients with a particular interest in eosinophilic disorders, and was the principal investigator for the Johns Hopkins T32 training grant that funds postdoctoral education related to careers in discovery in the fields of allergy and Immunology. His ongoing research work, which is funded by grants from the NIH, focuses on the glycobiology and function of Siglec-8 (which he co-discovered in the late 1990’s) and related inhibitory receptors on cells of the immune system.


Dr Schleimer is a co-founder of Allakos.

He majored in Biology at The University of California, San Diego andreceived a Ph.D. in Pharmacology and Toxicology at UC Davis. Dr. Schleimer received post-doctoral fellowship training at the Johns Hopkins University School of Medicine in the Division of Clinical Immunology. Dr. Schleimer joined the faculty at Johns Hopkins in 1981 and became Professor of Medicine in 1992. Dr. Schleimer moved to Chicago to become the Roy and Elaine Patterson Chair and Chief of the Division of Allergy-Immunology at Northwestern University Feinberg School of Medicine in the spring of 2004. Dr. Schleimer has published over 325 papers and was recognized as one of the most highly cited researchers of the last two decades worldwide by The Institute for Scientific Information (ISI). He has had continuous NIH funding for 30 years and presently has an NIH MERIT award, a T32 training grant, a NIH U19 program project grant on Chronic Rhinosinusitis and is coinvestigator or mentor on other NIH grants. He has served on numerous NIH committees and advisory boards for pharmaceutical companies and biotechnology firms. He is presently actively involved in studying the molecular mechanisms of allergic disease, focusing on inflammation, innate and adaptive immunity, cytokines and chemokines, food allergy, the molecular basis for anti-inflammatory steroid action in allergic diseases and the mechanisms of pathogenesis in Chronic Rhinosinusitis.


Head of Drug Product Development and Manufacturing



Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.

The company is seeking to recruit the Head of Drug Product Development and Manufacturing. The ideal candidate will possess the following:

Position Summary:

The Associate Director, Drug Product Development and Manufacturing will lead drug product development activities, and will be responsible for formulation development, stability, drug product fill and finish. Management of CMOs and CROs is a critical aspect of the job and will include frequent visits to the contractors depending on the intensity of the ongoing activities. This person will be responsible for the collection of data and the finalization of the reports and summaries required to support global regulatory submissions. The role involves significant cross functional collaboration with other functions, including drug substance manufacturing, analytical, quality assurance and regulatory. This position reports to the Vice President, CMC.

Primary Responsibilities:

  • Develop strategic phase-appropriate drug product development plans; responsible for drug product fill/finish process, product quality and compliance; providing PIP support in drug product manufacturing at CMOs.
  • Manage day-to-day activities to meet development timelines and support manufacturing of clinical materials
  • Serve as the subject matter expert in formulation, container closure system and drug product fill/finish.
  • Manage the company’s stability programs at CROs/CMOs by reviewing protocols, raw data, performing trend analysis and guiding OOS/OOT investigations
  • Author and review drug product manufacturing and characterization sections of Regulatory submissions (i.e. IMPD/INDs/BLA), and responses to Regulatory agency questions.

Qualifications:

  • PhD in Life Sciences or relevant field with a minimum of 8 years of relevant industry experience, or BS/MS with a minimum of 12 years of relevant industry experience.
  • Strong preference for at least 3 years of experience managing outsourced formulation development and drug product fill/finish at contract organizations
  • Broad, and in-depth expertise in mAb formulation development
  • Extensive experience with drug fill/finish process and solid knowledge of cGMP practices.
  • Experience with sterile, parenteral /injectable products
  • Experience in setting process and product specifications
  • Experience in designing and evaluating stability programs
  • Direct experience preparing and reviewing CMC documentation for regulatory filings and inspections required.
  • Experience meeting/interacting with FDA (and/or other Regulatory bodies) a strong plus.
  • Experience in early-stage and late stage development and small company environment is a plus
  • Experience in project management and team facilitation skills preferred

Other Information

  • Position may require occasional evening and/or weekend commitment
  • Position may require working with biological and/or chemical hazards
  • Position may require occasional travel (20%), domestic and international.

The salary is competitive and commensurate with experience and qualifications.

Interested applicants please send resume to careers@allakos.com

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.



Director of Analytical Development and Quality Control



Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.

The company is seeking to recruit a Director of Analytical Development and Quality Control. The ideal candidate will possess the following:

Position Summary:

The Director, Analytical Development & Quality Control will be the functional lead and have primary responsibility for all activities associated with analytical method development/optimization/validation, quality control, and stability testing of Allakos’ drug substance and drug products. The successful candidate will work closely with Development/Manufacturing/Supply Chain, Quality Assurance, Project Management, and Regulatory Affairs to ensure timely development and validation of methods as well as the timely testing and release of materials. This person will be responsible for the collection of data and the finalization of the reports and summaries required to support global regulatory submissions. In addition, this person will be responsible for establishing and maintaining excellent working relationships with multiple contract testing laboratories. Prior experience with method development/validation and the demonstrated ability to work effectively in an environment that utilizes contract testing laboratories for analytical development and quality control testing are requirements for this position. This position reports to the Vice President, CMC.

Primary Responsibilities:

  • Build and lead members of the Analytical Development (AD) & Quality Control (QC) groups. Establish adequate staffing to support aggressive growth plan
  • Advance and manage Allakos’ product specification system, quality control system and stability testing
  • Oversee all activities associated with quality control and stability testing of Allakos’ pharmaceutical products at Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs)
  • Identify and address technical and validation gaps in analytical methods and QC testing in preparation for BLA/MAA submissions and product commercialization. Work with CTLs and CMOs to devise and implement improvements in analytical methods
  • Identify, evaluate, and implement new analytical methods and quality control strategies
  • Ensure compliance of analytical testing activities with applicable compendia (eg., USP, NF, EP) and regulatory guidance documents
  • Coordinate and oversee analytical methods transfers to and between CMOs and CTLs
  • Manage the development and supplies of reference standards and critical reagents across testing sites
  • Contribute to or oversee the investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results
  • Work collaboratively with Development/Manufacturing/Supply Chain, to ensure that QC analytical methods are aligned with process needs/capabilities and product requirements
  • Serve as primary author or reviewer of CMC sections related to analytical methods and method validation, specifications, and stability in INDs, IMPDs, MAAs, BLAs, and other regulatory submissions

Qualifications:

  • Advanced degree (MS, PhD) in Chemistry, Biochemistry, Analytical Chemistry, or a related field preferred
  • At least 12 years relevant combined QC and AD experience. Previous 10 years of managerial experience required
  • Experience leading Analytical Development team and working in partnership with process development team to deliver appropriate product control strategy
  • Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to development, testing and stability of pharmaceutical products
  • Experienced in all phases of biologics drug development is a plus
  • Ability to travel up to 20%
  • Ability to effectively prioritize and demonstrated ability to deliver high-quality results on tight timelines
  • Excellent written and verbal communication skills
  • Accuracy and attention to detail
  • Excellent cross-functional team participation skills
  • Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues in a virtual environment
  • Willingness to work in a dynamic and changing corporate environment

The salary is competitive and commensurate with experience and qualifications.

Interested applicants please send resume to careers@allakos.com

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.



Associate Director of Purification Development



Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.

Position Summary:

The Associate Director, Purification Development will be the functional lead and have primary responsibility for all activities associated with purification process development/optimization/validation and formulations. The successful candidate will work closely with Supply Chain, Quality Assurance, Project Management, and Regulatory Affairs. This person will be responsible for the collection of data and the finalization of the reports and summaries required to support global regulatory submissions. In addition, this person will be responsible for establishing and maintaining excellent working relationships with contract manufacturing and contract testing laboratories. Prior experience with CMO management and serving as person-in-plant are requirements for this position. This position reports to the Vice President, CMC.

Primary Responsibilities:

  • Responsible for leading and directing all aspects of purification process development supporting all phases of drug development
  • Lead and develop technical staff
  • Develop strong interface with internal departments and contract manufacturing organizations/contract testing laboratories to ensure process operations are compatible
  • Author and review appropriate sections of regulatory filings
  • Transfer processes to contract manufacturing sites
  • Provide person-in-plant (PIP) support for critical manufacturing operations
  • Contribute to or oversee the investigation and resolution of deviations, out-of-specification (OOS), and out-of-trend (OOT) testing results
  • Work collaboratively with QA and RA to ensure that DS manufacturing is compliant with the applicable Corporate, Quality and Regulatory requirements
  • Serve as primary author or reviewer of CMC sections related to DS manufacturing in INDs, IMPDs, MAAs, BLAs, and other regulatory submissions

Qualifications:

  • PhD in chemical engineering, life sciences or relevant field, 9 years of relevant industry experience or BS/MS degree and 12 years of relevant experience
  • Experience with statistical design of experiment (DoE)
  • Direct experience in authoring & reviewing CMC sections for INDs and BLAs required, experience in setting product quality attributes, process and product specifications
  • Experience with technical transfer to Pilot and GMP manufacturing
  • Experienced in all phases of biologics drug development is a plus
  • Ability to travel up to 20%
  • Ability to effectively prioritize and demonstrated ability to deliver high-quality results on tight timelines
  • Excellent written and verbal communication
  • Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to development, testing and stability of pharmaceutical products
  • Accuracy and attention to detail
  • Excellent cross-functional team participation skills
  • Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues in a virtual environment
  • Willingness to work in a dynamic and changing corporate environment

The salary is competitive and commensurate with experience and qualifications.

Interested applicants please send resume to careers@allakos.com

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.



Clinical Data Manager



Position Summary:

Supports the Allakos Clinical Development and Medical Affairs/Bioanalytics teams by managing Data Management activities and personnel in the design and implementation of clinical studies. The position requires a highly-motivated individual to work collaboratively in a cross-functional team environment. This individual will play a key role in ensuring accurate, high quality clinical trial data in a fast-paced, start-up biotech environment. Overall responsibilities will include oversight of clinical data management activities from study start-up through study closure in support of trial objectives, regulatory submissions, publication activities and corporate goals. This position reports to the Vice President, Clinical Operations.

Primary Responsibilities:

  • Serves as the primary overseer/”point person” for Allakos clinical data management activities.
  • Works with clinical, biostatistics and regulatory teams to develop Study Protocols and Statistical Analysis Plans.
  • Oversees the collaboration and coordination of the design and implementation of clinical protocols and data collection systems including the development and maintenance of electronic Case Report Form (eCRF), CRF Completion guidelines, edit check specifications, data transfer specifications, and database audit plans.
  • Collaborates in the development, implementation and integration of IxRS systems, as applicable.
  • Performs and organizes cross-functional User Acceptance Testing (UAT) of the integrated clinical databases
  • Assists in the development of data quality plans.
  • Proactively organizes on-going data review throughout the conduct of clinical studies to ensure timely and appropriate identification of errors, trends, and discrepancies.
  • Responsible for the correction of errors and discrepancies through the site query process, for documenting permanent data issues, routinely communicating issues with team members and the delivery of a quality locked database for analysis.
  • Ensures data management timelines for assigned projects are met, up to and including the timely delivery of Tables, Listings and Figures for individual studies.
  • Oversees production of quality data deliverables for assigned protocols to support regulatory submissions and due diligence activities. Assists the Director of Medical Affairs and Bioanalytics in providing deliverables to support medical affairs and publication needs.
  • Participates in the review of clinical and regulatory documents, as needed, to assure data integrity and quality.
  • Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions.
  • Supports compliance with industry quality standards, guidelines and procedures. Participates in the development of department SOPs and standards/templates with focus on CDISC implementation.
  • Assists with the selection, development and evaluation of personnel and vendors to ensure the efficient operation of the function.
  • Oversees projects that have been engaged with Contract Research Organizations (CROs), as well leads and manages internal projects.
  • Participates in providing suitable input into corporate and department budget process and management.
  • Other data management related duties as assigned.

Requirements:

Bachelor’s degree preferably in Life Sciences or Mathematics; an equivalent combination of education and applicable job experience may be considered. A minimum of 5 years progressively responsible experience in clinical data management in the pharmaceutical/biotechnology/CRO setting with 2 years’ experience in a leadership role.

Must possess:

  • Previous experience managing projects in a Data Management/Bioanalytics group, with exposure to the complete DM study cycle (Start-Up, Conduct, Close-Out)
  • Experience and understanding of ICH and GCP
  • Experience with Electronic Data Capture (EDC) and IxRS systems
  • Knowledge of medical terminology
  • Knowledge of coding dictionaries (Medical Dictionary for Regulatory Activities -MedDRA, WHO Drug)
  • Excellent verbal and written communication skills as well as interpersonal and organizational skills
  • Proficiency in MS Office applications
  • Proficiency with data management systems and knowledge and understanding of supporting technologies (e.g., EDC, IxRS, ePRO, SAS) and industry standards (e.g., CDISC)
  • Self-sufficient and able to work with minimal oversight.
  • Demonstrated skill at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to earn and foster cooperation with and of others.
  • Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs.
  • Willingness and ability to travel as required.

The salary is competitive and commensurate with experience and qualifications.

Interested applicants please send resume to clinicalcareers@allakos.com

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.



Protein Chemistry Scientist/Research Associate



Allakos is a clinical-stage company developing antibodies that target receptor molecules present on the surface of immune effector cells involved in allergy, inflammation, tissue damage and proliferative disorders.

The company is seeking to recruit a Scientist or Research Associate in Protein Chemistry group within Research and Development department. The candidate will have an opportunity to participate in a dynamic and challenging work environment, and contribute to early and late stage programs.

Responsibilities:

Purification of proteins and antibodies to support research and development activities

  • Cell culture supernatant harvest and filtration
  • Protein purification
  • Protein concentration and formulation

Protein analysis and characterization

  • Soluble aggregate formation (SEC HPLC)
  • Purity and fragments formation (SDS-PAGE)
  • Visible aggregation (UV/VIS spectroscopy etc.)
  • Perform stability studies of purified proteins
  • Protein-protein interaction Biacore, Forte Bio and ELISA
  • Protein conjugations and modifications

The scientist or research associate will produce protocols and reports, transfer protocols to CMOs and CROs and actively participate in team meetings.

The ideal candidate will possess the following:

  • BSc, MSc or Ph.D. degree in biochemistry, protein chemistry, biology, or related scientific field
  • Minimum of 2 years industry or postdoctoral experience
  • Experience in protein purification such as Protein A, IMAC, ion-exchange and HIC
  • Experience in tangential flow filtration
  • Analytical techniques such as SDS-PAGE, UV spectroscopy, and HPLC
  • Proficient use of AKTA, Agilent HPLC, and ForteBio systems

The salary is competitive and commensurate with experience and qualifications.

Interested applicants please send resume to researchcareers@allakos.com



Scientist/Senior Research Associate in Immunology/Pharmacology



Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.

The company is seeking to recruit a senior scientist/ associate director in Research Immunology. The ideal candidate will possess the following:

  • Ph.D. in biological sciences with relevant experience in immunology
  • B.Sc. with more than 3 years of relevant experience in immunology
  • Hands-on expertise with in vivo models of allergic or inflammatory disease, fibrosis or COPD
  • Experience in working with primary human cells and lines
  • Excellent organization and troubleshooting skills
  • Strong interpersonal communication skills
  • Ability to work cooperatively in a team-based environment

Responsibilities:

  • Conduct chronic models of allergic and inflammatory disease and fibrosis
  • Design and execute functional and characterization assays on diverse human and murine primary cells and cell lines

The salary is competitive and commensurate with experience and qualifications.


All inquiries

75 Shoreway Road, Suite A
San Carlos, CA 94070

info@allakos.com

(650) 597-5002