Myovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for women’s health and endocrine diseases with a mission to become the global leader in women’s health. Myovant launched in the spring of 2016 and completed just a few months later, in October 2016, the largest biotechnology IPO of the year. Since then the company has been on a rapid growth trajectory and is on track to become an exciting new success story. Myovant has received top line data results for relugolix in patients with Uterine Fibroids and expects to file their first NDA at the end of 2019. The results for the Phase 3 studies in Prostate Cancer and Endometriosis are expected to follow by the end of 2019 through early 2020. Each of these indications represent major commercial opportunities for which Myovant has retained full US and EU rights. In addition, Myovant has global rights to a second product candidate, MVT-602, which is being developed for the treatment of female infertility as part of assisted reproduction. Myovant is seeking experienced, highly motivated individuals to lead and continue to grow its clinical as we grow the company and realize our vision of becoming the global leader in women’s health. As part of that vision we strive to build one of the best clinical operation organizations in our industry. The Company is located in Brisbane, California.
The Sr. Clinical Trial Manager (Sr. CTM) is accountable for the day-to-day operational oversight of one or more clinical studies including study start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity typically is coordinated in conjunction with one or more Contract Research Organizations (CROs). The Sr. Clinical Trial Manager role will report to Associate Director, Clinical Operations.
Essential Duties & Responsibilities
• Manages the operational aspects of clinical studies
• May serve as the Study Management Team (SMT) lead and the primary Clinical Operations point of contact for cross functional team members and CROs, as appropriate
• Prepares and/or reviews/approves study-related documents including, but not limited to, Protocols, Informed Consents (ICFs), Project Management Plan, Study Monitoring Plan, Laboratory Manual, Patient Diaries, Clinical Site Procedures Manual, Pharmacy Manual, CRFs/CRF Completion Guidelines, Clinical Study Report (CSR), and NDA submission documentation, as appropriate
• Prepares metrics and updates for management, as assigned
• Proactively identifies potential study issues/risks and recommends/implements solutions
• Participates in CRO/vendor Request For Proposal (RFP) and selection process for outsourced activities
• Manages CRO/Clinical Service Providers (CSPs) interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, Trial Master File)
• May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
• Manages oversight of clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
• May serve as a line manager to one or more Clinical Trial Managers (CTMs), Clinical Trial Management Associates (CTMAs) and/or Clinical Trial Assistants (CTAs)
• Serves as a leader and mentor to junior team members
• Participates in the development, review and implementation of departmental SOPs and processes, including development and/or review of templates, tools, and training materials
• Organizes, leads, and manages internal team meetings, investigator meetings and other study-specific meetings as appropriate
• Serves as a liaison and resource for investigational sites and may have direct interaction with key opinion leaders (KOLs), as needed
• Reviews site-level study documents (ICF template and study tools/worksheets), investigator contracts, and site payments, as needed
• Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• Performs some or all of the duties and responsibilities outlined for a Clinical Trial Manager, as needed
Core Competencies, Knowledge, and Skill Requirements
• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
• Must have a high degree of professionalism, demonstrates a positive, ‘can do’ and service-oriented attitude and ability to work with limited direction
• Detail-oriented with a commitment to accuracy
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks under limited direction
• Effective time management and organization skills with ability to multi-task and shift priorities quickly while working under tight deadlines
Communication & Interpersonal Skills
• Must have excellent interpersonal, written and verbal communication skills
• Skilled in developing collaborative internal and external relationships
• Ability to effectively communicate, collaborate, and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
• Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
• Must have strong knowledge of clinical drug development and clinical study processes
• Extensive experience in managing CROs and other vendors
• Proven project management skills and study leadership ability
• Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint); MS Project a plus
• At least 7+ years of experience in the pharmaceutical or biotechnology industry
• BS or BA in a relevant scientific discipline
If you require any accommodations, please email firstname.lastname@example.org.
Equal Employment Opportunity