Senior Clinical Trial Manager

Employment Type

: Full-Time


: Miscellaneous

Why Work for Us Are you ready to use your experience and expertise to make an impact on patients' lives? Audentes 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 Audentes Therapeutics Audentes Therapeutics, An Astellas Company, 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 their 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: Our Values: * 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. The Role The Senior Clinical Trial Manager position will play a key role on the Audentes Clinical Operations team. Reporting to the Associate Director/Director, Clinical Operations, the Senior Clincial Trial Manager will be responsible for the implementation of clinical trial activities across one or multiple studies across our development programs. Working closely with investigative site personnel, CROs, and other study vendors and under the direction of Director/Associate Director of Clinical Operations, the Senior CTM will drive the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. The ideal candidate has proven clinical trials experience within the biotech or related industries preferably with neuromuscular disease area experience. To be successful, the incumbent will be a strong collaborator and communicator, possessing outstanding clinical operations skills and an attitude that fits our #GSD (Get Stuff Done) culture. The position will be based in our San Francisco office. Primary Responsibilities * Manage defined aspects of clinical trials to ensure trials are completed on time and in compliance with SOPs, FDA regulations and ICH/GCP guidelines * Perform the activities associated with the implementation and monitoring of clinical trials such as development of study plans and materials * Work with Medical Monitor and Director/Associate Director/Director of Clinical Operations to select investigative sites, train investigators and investigative site staff, and prepare materials for investigator meetings * Maintain or drive management of study timelines including identifying and communicating trial issues that will impact budget, resources and/or timelines * Leader of one or more Study Management Teams driving cross functional activities support study execution * Lead the clinical operations activities supporting database design, collection and cleaning to facilitate comprehensive data analysis and reporting needs * Lead vendor oversight activities across all vendors within one or multiple studies within designated programs * Manage external vendor partners. Includes review of invoices for accuracy compared to vendor contract; may aid in the development of technical specifications for vendors (e.g. scope of work) * Assist in creating and implementing departmental procedures in compliance with industry standards and regulatory requirements * Travel (including international) up to 20% * Contribute to wider organizational goals and/or activities as assigned About you Must Have/Required * BS/BA and/or MS degree in the Life Sciences area or related degree * 6+years' industry drug development experience; 3+ years' experience as a Clinical Trial Manager * Expert knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials * Proven experience in building relationships with medical personnel at clinical site(s) to achieve enrollment and other trial goals * History of success in managing clinical trial vendors * Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems * Demonstrated problem solving abilities and strong organizational skills * Must be self-motivating, prioritize and manage a large volume of work, and show attention to detail * Strong interpersonal skills with reputation for collaboration with colleagues; influencing up, down and across the organization * Demonstrated success working with key external stakeholders including, KOLs and Therapeutic Area Experts, Site Personnel, including Principal Investigators, Study Coordinators and managing external partners and vendors * Outstanding written communication skills including writing technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents * Ability to travel up to 20% domestic and international * Strong computer skills including MS Office (Word, Excel, Outlook) * Models our Core Values: Be Bold, Care Deeply, #GetStuffDone - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted May Have/Preferred * Experience in conducting clinical trials in gene therapy, rare disease with pediatric populations in the neuromuscular disease area * Previous independent on-site clinical monitoring or clinical research coordinator experience * Experience with direct report management * Experience in a small company and high growth, fast-paced environment All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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