Astellas Pharma Manager, Clinical Sciences - Respiratory Therapist in San Francisco, California
Why Work for Us
Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.
About Astellas Gene Therapies
Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.audentestx.com .
Be BOLD (Find a Way)
Care Deeply -- for our patients, each other and our work
#GSD (Get Stuff Done)
What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.
Lung function and respiratory muscle strength are affected in many individuals living with serious, debilitating, neuromuscular conditions. This position provides a unique opportunity to employ the skills of an experienced Respiratory Therapist or a Physical Therapist with respiratory focus within the drug development industry. This role will involve the conduct of medical literature reviews, and potentially patient evaluation/functional pilot studies, to understand how respiratory muscle strength and pulmonary function in individuals living with neuromuscular disorders are affected, and translate these findings into meaningful clinical outcome assessments that can be evaluated within clinical trials. This role will also require an in-depth knowledge of respiratory strength and pulmonary function assessments used to monitor disease progression as well as the treatment regimens that are used to manage function in these neuromuscular conditions. The individual will be a valuable member of the cross functional team, collaborating closely with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, Medical Affairs, amongst others, to inform clinical trial design, develop clinical evaluator manuals, support site training and data collection, participate in data quality reviews, support data analysis and lead interpretation of the respiratory strength and pulmonary function outcomes.
Respiratory Therapist or Physical Therapist with a focus on respiratory strength and pulmonary function assessments:
Recommend patient population and pulmonary function assessments for evaluation in clinical studies.
Develop clinical evaluator manuals and conduct site training to ensure the standardized administration of pulmonary function assessments and provide support throughout the clinical study.
Participate in regular data reviews to ensure data quality and integrity of pulmonary function assessments.
Contribute to statistical analysis plans supporting data analysis of pulmonary function assessments.
Lead interpretation of the pulmonary function assessments evaluated within the clinical trial.
Actively participate in internal cross functional meetings and present at Investigator Meetings.
Provide insights to selection and oversight of vendors supporting clinical studies
Manage study deliverables within agreed timelines.
Co-author relevant sections of clinical documents and publications pertaining to respiratory muscle strength outcomes (e.g. Clinical Protocols, Informed Consent, Clinical Study Reports, Investigator Brochures, study manuals, charters, abstracts and manuscripts) and documentation for submission to regulatory agencies.
Contribute to the preparation of sections of IND/BLA documents.
Contribute to addressing questions and inspections from the regulatory agencies.
Lead Pulmonary Function Steering and Adjudication Committee discussions as needed.
Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
Clinical trial support
Provide input to protocol development and definition of pulmonary function efficacy endpoints for Phase 1, 2 and 3 clinical trials and registry studies.
Coordinate closely with Clinical Operations to develop clinical evaluator manuals, train clinical site staff, and manage relationships with peers at clinical trial sites.
Support feasibility assessment related to clinical study site selection.
Provide site supervision, educating and training research partners, and oversight to ensure clinical outcome assessments are administrated in a standardized manner.
Serves as a scientific resource to medical affairs and commercial partners as appropriate to support activities such as advisory boards, investigator meetings, and training initiatives including preparation and delivery of presentations.
Identifies, gains access to, and develops professional relationships with targeted Key Opinion Leaders (KOLs), external partners such as clinical investigators, clinicians, scientists, and vendors in therapeutic areas of commercial and research interests.
Provides education relative to disease state and products across the product lifecycle to healthcare providers and researchers.
Manage pulmonary function assessments licensing and purchasing (including required equipment/certificates), as appropriate.
At least a Associate degree in Respiratory Therapy or Masters degree in Physical Therapy equivalent with current licensure and more than 2 years of direct patient experience managing patients with neuromuscular conditions.
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable.
Direct participation in clinical trials.
Proven leadership when working with collaborative, multi-functional teams.
Excellent and effective written, verbal communication and presentation skills.
Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.
Proficient in data analysis software (Excel, SigmaPlot, GraphPad, SPSS, SAS, or R, etc) and data presentation.
Ability to travel up to 30% (may increase based on study requirements) domestic and international.
Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
Experience in a small company culture and high growth, fast-paced environment.
Continually educates self on global market issues / trends and product knowledge as it pertains to specific business responsibilities in key therapeutic areas.
Category Pharmacology and Toxicology
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans