Myovant Sciences is a biopharmaceutical startup company focused on delivering innovative women’s health and prostate cancer solutions. We are currently seeking a qualified, highly motivated, experienced individual for the position of Associate Director, Clinical Operations. The position reports to the Vice President, Clinical Operations. The location of the position is in Brisbane, CA.
Reporting to the Vice President, Clinical Operations, the Associate Director, Clinical Operations directs the planning, execution, monitoring, and completion of any or all of international Phase 1 to 3 and post approval clinical trials. The Associate Directorinteracts with Contract Research Organizations (CROs), external physician investigators, other contracted service providers, and all levels of internal staff - acts as the Clinical Operations lead on a variety of cross-functional projects, interacting with team members from a variety of departments, including but not limited to Non-Clinical Development, Clinical Development, Biostatistics and Data Management, Clinical Trial Materials Supply, Regulatory, Quality, Project Management, Finance and Legal. The Associate Director serves as a member of the Clinical Operations senior management team, contributing to departmental polices and SOPs, project and staffing plans and the like.
Essential Duties & Responsibilities
- In collaboration with internal and external scientific and medical experts, plan and execute clinical trials to support clinical development strategies and plans; author, review and/or manage a wide variety of activities, including for example, clinical trial synopses, protocols, case report forms, investigator brochures, and the like; manage internal teams to review and approve clinical study reports in accordance with overall project timelines
- Prepare Request for Proposal documents and with cross-functional project team, solicit and evaluate bids; lead contracting process with selected CROs, collaborating with relevant departments such as Legal and Finance
- Manage CROs to execute clinical trials in accordance with contracted scope, costs and timelines; actively engage with CROs on defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site initiation activities, patient screening and randomization rates, and data collection activities
- Interact with investigators and sites as needed to support CRO and ensure clinical trials are conducted according to plan
- Identify risks to clinical trial execution success, proactively communicate risks to internal and CRO teams, and bring team together to develop and implement risk mitigation strategies and tactics to enable trials to complete as planned
- Keep current with clinical development and regulatory changes, technology trends and patient engagement
- Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies
- Lead, direct, manage, develop, coach and evaluate direct reports and other employees in group in accordance with the Company’s Human Resource policies and plans
- Act in accordance with general Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by employees in reporting and other departments
- Other duties as assigned
Core Competencies, Knowledge and Skill Requirements
- Working knowledge and experience with Word, PowerPoint and Excel
- Effective time management and organization skills
- Ability to multi-task under limited direction and on own initiative
- Good interpersonal, written and verbal communication skills
- 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 excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Daily demonstrates a positive, ‘can do’ and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Communication & Interpersonal Skills
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Employees across the Roivant companies, visitors
- BS degree (MSc preferred) and a minimum 12-15 years in a Clinical Operations/Trial leadership role in the biotech/pharmaceutical industry
- A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP
- Demonstrated track record in conducting clinical trials in an out-sourced model
- Strong behavioral bias towards productivity and being proactive
- Excellent interpersonal, communication (oral and written), analytical and organizational skills.
- Strong influencing and negotiation skills
- Proven ability to manage multiple projects and complex timelines in a team environment
- Demonstrated leadership capacity in a cross-functional project environment
- Excellent team management skills, ability to lead, train and mentor team members at all levels; experience building teams highly desired
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Ability to travel approximately 15% within North America and internationally
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Equal Employment Opportunity