aTyr seeks an exceptional individual and top performer to lead the Company’s physiology team in the development of therapeutics. The director will lead aTyr’s strategic exploration of the in vivo physiologic functions of these novel proteins and their potential to form the basis of transformative medicines for patients with significant unmet needs.

Specifically, the director will conduct, analyze, interpret and report pre-clinical safety, pharmacokinetic and proof-of-concept studies at aTyr and in collaboration with outside vendors. The candidate will also assist in the identification of new clinical indications for Physciocrine proteins and be responsible for feasibility assessment in pre-clinical studies.

The successful candidate will have a Ph.D. and 15 years or more of experience in the pharmaceutical or biotechnology industry, ideally in biologics and pharmacology. The candidate must be experienced with state-of-the art animal models and IND enabling pre-clinical studies. A deep understanding of immune-mediated disease mechanisms is critical. Experience in muscle disease with inflammatory components will be considered a major advantage. A track record in successful oversight of in vivo pharmacology team and direct responsibility for studies that contributed to successful a biological license application will be considered very favorably.

The candidate must be a decisive, independent thinker and outstanding team leader. The candidate will be an excellent written and verbal communicator and will lead by example. The director will interact effectively with aTyr upper management and collaborators at academic institutions and CROs. In addition, the successful candidate will have demonstrated statistical and analytical skills and an excellent publication record in high-level peer reviewed journals. The candidate will also have the capacity to:

• Manage, develop and mentor scientific staff
• Create and implement innovative and efficient operational processes
• Manage effectively, the physiology departmental budget
• Experience writing IND documents - author pre-clinical sections of regulatory documents
• Present progress, data, interpretations and next steps to management, corporate partners and regulatory bodies
• Work well in dynamic high-paced team environment
• Maintain deep and current understanding of relevant biomedical literature

aTyr Pharma is a privately held biotech, backed by leading life sciences investors with an established, dominant intellectual property portfolio related to Physiocrines as therapeutics. For additional information about aTyr Pharma, please visit our website at www.atyrpharma.com.

In addition to a competitive compensation package with stock options, aTyr Pharma also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, life, disability and a 401(k) Plan.

Degree Requirements: Ph.D. with 5+ postdoctoral experience, including experience in the biotechnology and pharmaceutical industry is required. Strong publication record required.

For consideration, please submit your resume and cover letter referencing job #32MA to jobs@atyrpharma.com. aTyr Pharma, Inc. is an EEO employer.

aTyr Pharmaceuticals is seeking a Clinical Project Manager to assume a leadership role in the conduct of global clinical trials to ensure the safety of subjects, the quality and integrity of data, and the proper management of study procedures according to ICH and GCP regulatory guidelines. Avedro, Inc.As a key member of the aTyr team, this high-energy, dynamic individual will have overall responsibility for the successful execution of clinical trials from IND to study start-up to NDA submission. Reporting into the VP of Clinical Affairs, this cross-functional leader will proactively identify and resolve clinical study issues, developing study project plans with timely completion. This person will be responsible for compiling and/or reviewing key study related documents such as study protocols, CRFs, source document worksheets, SAPs, CSRs, and informed consents. This candidate will work closely with colleagues in Regulatory Affairs, Legal, and Research as well as external collaborations to develop and execute clinical trial(s) for existing and new compounds.

• Coordinate all aspects of domestic and international clinical trial(s) from study start-up through close-out. This includes responsibilities across operations, study development, and project management.
• Generate clinical timelines and budgets and manage resource requirements across assigned trials
• Collaborate with independent clinical advisors during the development of clinical protocols
• Serve as a key member on project teams and participate in crossfunctional meetings as needed.
• Recruit, negotiate compensation, manage deliverables and provide feedback to study consultants/contractors (contract research organizations (CROs), biostatisticians, independent core laboratories, clinical/medical experts, data managers, and medical writers)
• Oversee site and investigator selection process
• Interact externally with clinical investigators, investigational sites, CROs, etc.
• Develop and/or review clinical project deliverables, such as protocols/amendments, Case Report Forms (CRFs), investigator brochures, informed consent, trial manuals, operational plans and other trial related documents
• Manage tracking and reporting of clinical trial status, including trial supplies, enrollment of subjects, regulatory document flow, study timelines, performance metrics, data flow, etc.
• Provide oversight of clinical trials(s) to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
• Responsible for the identification and reporting of project risks and the development and implementation of the mitigations for these risks
• Following established SOPs, ICH-GCP, and other applicable regulatory requirements across all tasks, as well as developing, revising, and implementing new SOPs as needed;
• Leading study data review
• Responsible for ensuring the study is “audit ready” at all times (project team training records, central files, system validation, etc.)

• Bachelor’s degree in a science-based field
• 6+ years of relevant hands-on phase I -III drug experience in a sponsor setting
• Experience in managing external vendors
• Excellent communication, organizational, and problem solving skills
• High attention to detail
• Strong knowledge of ICH-GCP guidelines and other regulatory requirements for clinical trial management
• Strong study management track record showing clear proficiency in clinical project management skills
• Excellent Microsoft Office and Project skills
• Ability to effectively interface with key medical personnel in-house and at clinical sites
• Ability to lead multi-disciplinary teams
• Experience negotiating CTAs and other documents
• Work well in dynamic high-paced team environment

aTyr Pharma is a privately held biotech, backed by leading life sciences investors with an established, dominant intellectual property portfolio related to Physiocrines as therapeutics. For additional information about aTyr Pharma, please visit our website at www.atyrpharma.com.

In addition to a competitive compensation package with stock options, aTyr Pharma also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, life, disability and a 401(k) Plan.

Degree Requirements: Ph.D. with 5+ postdoctoral experience, including experience in the biotechnology and pharmaceutical industry is required. Strong publication record required.

For consideration, please submit your resume and cover letter referencing job #40KB to jobs@atyrpharma.com. aTyr Pharma, Inc. is an EEO employer.