Senior Clinical Trial Manager (Contract)

SENIOR CLINICAL TRIAL MANAGER (CONTRACT)
 
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.
  
POSITION SUMMARY:
 
The Senior Clinical Trial Manager is the operational leader of the Trial Team and will closely partner and
proactively coordinate internal stakeholders, manage CROs and vendors, and collaborate cross
functionally to deliver trials according to plan and while ensuring quality in accordance with FDA,
EMEA, GCP, and ICH guidelines. Trials may be international and/or domestic, First in Human/Phase I
– IV, and across multiple indications.
 
This position has the potential to be fully remote. Occasional travel will be required for in person meetings.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES:
·       Manage all operational aspects of Clinical Trials, and ensure successful execution per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
·       Lead the Trial Team and coordinate input from internal stakeholders
·       Lead the team in the evaluation, selection, and management of Global Contract Research Organizations (CROs) and other external vendors
·       Conduct on-going trial risk identification and analysis, and develop risk-based mitigation strategies for a variety of complex problems, in order to maintain study deliverables
·       Contribute to the development and presentation of Clinical Trial operational strategy and updates to senior/executive leadership
·       Contribute to global regulatory submissions (FDA, EMA, Health Canada and other governing regulatory bodies)
·       Develop, review, and approve Quality Documents
·       Oversee the development of site Clinical Trial agreements and other relevant documents
·       Review, contribute to and/or author the creation and finalization of key trial documentation: Protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Laboratory Manual, Manual of Operations, Clinical Study Report, etc.
·       Liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships
·       Collaborate with CROs to develop and ensure execution of activities outlined in various study plans (e.g. data management, risk management, safety management, and study communication plans)
·       Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for Clinical Trials
·       Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
·       Uphold company values and focus on making Clinical Trials patient and site centric through the use of innovative ideas and technologies
·       Travel: up to 25% domestic and international
 
QUALIFICATIONS
·       Bachelor’s degree preferred in a relevant scientific or healthcare discipline or equivalent experience
·       Minimum of 3-5 years of Clinical Operations experience within a biotech/pharma environment
·       Management of FIH - Phase 3 Programs from start-up to registration, as well as understanding of drug development from pre-IND through NDA
·       Experience managing CROs, budgets, and timelines
·       Experience independently and proactively managing Clinical Trials in Ventus therapeutic areas (immunology, inflammation, neurology) preferred
·       Excellent team management abilities with a comfort level working with senior management, and ability to influence without authority
·       Establish and nurture highly effective relationships with colleagues and key stakeholders, of diverse backgrounds and expertise, that support and advance trial team goals and objectives
·       Demonstrated ability to solve problems with innovative solutions along with strong organizational skills
·       Knowledge of GCP’s governing Clinical Trials and working knowledge of FDA, EMA and ICH registrations and guidelines
·       FDA and other Regulatory Agencies inspection experience a plus
·       Solid oral and written communication skills required
·       Ability to organize, prioritize, and manage multiple priorities required
·       Ability to thrive in a fast-paced, entrepreneurial environment, and the flexibility to adapt to changing program needs
 
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
 
 
COMPENSATION
 
The hourly rate for this position is $110-125/hour. Day One Bio considers a range of factors when determining compensation. These considerations mean actual compensation will vary.
  
Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
 
Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.