aTyr Pharma is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality and signaling pathways of tRNA synthetases. aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets. aTyr’s primary focus is ATYR1923, a clinical-stage product candidate which binds to the neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases. aTyr is publicly traded on Nasdaq under the symbol “LIFE”. For more information, please visit http://www.atyrpharma.com.
Patients and their challenges provide tremendous drive and meaning to what we do at aTyr. We seek a talented and successful individual that deeply desires to participate in our process to make medicines that change a patient’s life forever. In close collaboration with the study medical monitor, provide scientific guidance and support to the team. The Director, Clinical Science will be responsible for various aspects of clinical study execution including: protocol writing, building study infrastructure, staff training, data cleaning/analysis, investigator interaction and support of regulatory filings.
- Leads the development and execution of clinical strategies and study plans, applying strong scientific knowledge and operational knowledge that translate research plans into high quality studies.
- Maintains strong scientific and clinical knowledge in specific therapeutic and relevant disease indications to assist in study concept and protocol development.
- Provides scientific and medical expertise to collaborate with other departments on final study design, protocol, and informed consent design.
- Writes medical data review plans, charters and specific sections of study manuals and investigator meeting materials.
- Contributes to the development of CRFs, data checks, patient profiles and statistical analysis plans.
- Leads internal clinical data review meetings in collaboration with the clinical lead/medical monitor; supports ongoing data cleaning (query generation, coding review, SAE reconciliation) and data trend analysis.
- Organizes and manages external medical advisory committees for the study team such as DSMBs and Scientific Steering Committees, as directed by the medical monitor.
- Provides analytical support of clinical trial data (safety, efficacy and biomarkers), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
- Develops or contributes to abstracts, manuscripts, clinical presentation slides and other external facing materials.
- Addresses investigator questions regarding protocol and related scientific issues.
- Assists in writing or reviewing regulatory documents such as briefing books or health authority requests for information, IND annual reports, Investigator Brochures, and regulatory filings.
- Identify risks and recommends potential mitigation strategies that can impact the successful execution of a clinical study
- Assists in close out of clinical studies by writing clinical science sections and assisting in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
- Supports and mentors Clinical Science/Medical staff
- This position will work closely with Clinical Operations, Regulatory, Biostatistics, Data Management & Non-Clinical Research teams.
- PharmD, PhD, MSN, MD preferred; other life sciences degrees considered if accompanied by extensive scientific and/or drug development experience
- 8+ years of relevant industry experience working for biotechnology or pharmaceutical company in clinical development with knowledge of drug development process.
- Respiratory, immunology and/or oncology experience in the clinical science role strongly preferred.
- Proven experience in the submission of INDs and BLAs, as well as interactions with US and EU health authorities.
- Proven success in conducting global Phase 1 through 3 clinical studies
- Flexible and adaptable to quickly changing priorities, and willingness to move between projects to provide support/expertise as business needs dictate.
- Experienced with data capture and analysis programs such as Prism, JMP, SpotFire and Medidata Rave or similar.
- Strong understanding of ICH GCP, as well as general knowledge of industry practices and standards.
- Excellent oral and written communication skills; able to explain complex issues in a simple manner.
- Ability to work effectively in a fluid, fast-paced team-based environment
- Self-motivated, self-disciplined and able to function independently as well as part of a team
- Highly organized with attention to detail, clarity, accuracy and conciseness
- Excellent computer proficiency (G-Suite, MS Office Suite)
Further Recruiting Information
For additional information about aTyr Pharma, please visit our website at www.atyrpharma.com. aTyr Pharma, Inc. is an EEO employer.
In addition to a competitive compensation package with stock options and an Employee Stock Purchase Plan, aTyr Pharma also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, life, disability and a 401(k) matching contribution.
For consideration, please submit your resume and cover letter referencing job #196GW to email@example.com. aTyr Pharma, Inc. is an EEO employer.