Role: Associate Director, Clinical Operations
We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working beyond study management and into program management. The AD leads activities to oversee the conduct of clinical research at our Company in accordance with FDA, EMA, GCP, and ICH guidelines. This role will be responsible for collaborative oversight of cross-functional study team activities, as well as exceptional management of and partnership with external vendors and stakeholders (e.g., CROs, central labs, IRBs/ECs, and other external partners).
Who are we looking for?
· You have been working effectively in an independent trial management role for at least 3 years and are looking for an invigorating role where you can work autonomously on a high profile company program to execute study deliverables with quality.
· You are an energetic and passionate Clinical Operations professional who likes to think outside of the box, proactively seeks out and recommends process improvements and is passionate about the company’s mission of discovering and developing new medications
· You are a resourceful self-starter and team player with a strong results orientation
· You are open and authentic and can develop trusting relationships to move projects forward despite challenges.
· You act like an owner and take accountability; you are reliable
· You are resourceful and apply critical thinking to solve problems and add value to the Clinical Development team
· You have strong written and verbal communication and know how to seek clarity in ambiguous situations
What are we looking for?
· A driven professional who is comfortable supporting the development of procedures in parallel with doing the work
· A collegial team player who enjoys working in close collaboration with external vendors and teams; someone who understands the criticality of vendor partnerships for the execution of clinical trial conduct
· A person who thrives in a small company atmosphere and is willing to “roll up their sleeves” to support all aspects of clinical trial execution (some CTA tasks through program management)
· A person who acts with a sense of urgency and a quality-mindset
What are we offering?
· Membership within a growing, supportive, highly connected and collegial organization
· Being part of passionate, involved, fun! and cutting-edge Clinical Development Team – the ability to wear multiple hats and gain exposure to many aspects of the business
· Ability to develop within Clinical Development Operations under strong mentorship; future potential opportunity to be a line manager and develop a team
· Exposure to pioneering science and the discovery of drugs to help treat patients with cancer
What you will do:
· Leads the activities of the protocol level team as it relates to study-level strategy, timelines, goals, and quality; Liaises with cross functional team members for coordination of clinical study support to include but not limited to drug supply management, quality management, regulatory management initiatives
· Participates on the molecule Program Team
· Evaluates, selects and ensures appropriate oversight of Contract Research Organizations (CROs) and other external vendors. Builds solid relationships with key counterparts at CRO(s) and other external vendors; participates in CRO Governance, where applicable
· Coordinates the development and distribution of critical study documents, including Informed Consent Forms, operational documents, study reference documents, site materials, trainings and other study related documents; supports the development of clinical study protocols, clinical study reports and other documents as needed
· Communicates with clinical trial sites as appropriate to ensure optimal Sponsor-Site relationships
· Drives site start-up, subject enrollment, clinical monitoring, site and vendor compliance activities and data metrics from CROs and other external vendors.
· Communicates trial status within and outside the study team to ensure cross-functional alignment of expectations, priorities, and deliverables
· Develops and manages the study-level budget(s) and demonstrates accountability for the management of the budget through facilitation of WOs, CNFs and change orders according to study needs and tracking vendor performance against scopes of work, contracts, and invoices; manages budget forecasting and accruals in collaboration with Company FP&A.
· Analyzes clinical study and investigative site risks and implements corrective actions, where required
· Provides oversight of the applicable study drug(s) including supply projections, and partners with the Clinical Supply Chain for study drug distribution, labeling and destruction
· Performs quality assurance checks (e.g. reviewing protocols for operational effectiveness, monitoring trip reports for potential gaps in site/CRA training, conducting co-monitoring visits at clinical sites, reviewing data listings at interim analysis milestones)
· Supports and collaborates with GCP QA during site/study audit and vendor selection/auditing activities
· Leads Clinical Operations preparation of inspection readiness activities for FDA and other applicable regulatory body audits and/or meetings
· Owns the Trial Master File for assigned trials; ensures appropriate quality oversight and QC of required elements of TMF
· Maintains internal document repositories (e.g. Sharepoint)
· Assists with identifying and implementing best practices and continuous improvement plans within the company
· Participation in SOP, work instruction, and/or template development and review, as required
· Performs administrative functions and additional duties as assigned and appropriate
What you will bring:
· A deep understanding of Clinical Operations and trial management
· A willingness to learn new things, adapt to new ways and go with the flow
· An ability to determine priority and risk associated with study and program decisions
· A positive, can-do attitude and a team mindset
· An interest in your own personal development
Transparency: We work with honesty, openness, and integrity.
Community: We collaborate and thrive together.
Patient-Focused: We are committed to finding new medicines for patients.
Resolve: We never give up on our mission.
When You Join Us You Will Have: One day a week in office
• Location reachable by public transportation (Red Line)
• Customized and competitive health coverage, including medical offered through BCBS (HMO/PPO), dental, and vision
• Health Savings Account for medical expenses
• Eligible from the first day for 401K with 100% match of the first 5%
• A robust package of Company-paid insurance coverage, including life insurance, short-term and long-term disability
• Unlimited time off and 11 Holidays
• Winter Break: Company is closed for a Winter Break between Christmas and New Year
Location: Cambridge (Kendall Square), MA