Your Opportunity:
Walden Biosciences is a privately held, venture capital backed company with a mission to transform the treatment of kidney disease by reversing its progression and enabling and inspiring patients to resume their normal lives. We are developing first-in-class, highly targeted therapies for individuals living with both acute and chronic renal diseases. Our objective is to transform the treatment of renal diseases, providing patients with treatment options where currently few exist. You will have an opportunity to help us bring this mission to life.
As an integral member and leader of our Clinical Operations team, the Head of Clinical Operations will report to the Chief Medical Officer (CMO) and will be responsible for operational strategy, execution, and the management of Walden’s clinical programs. The Head of Clinical Operations will assist the CMO in defining strategy, policy (e.g., SOPs), process, and initiatives, as well as planning and managing cross functional activities to ensure individual, departmental, and corporate goals and objectives are met on time, while maintaining or exceeding quality requirements and within budget. This includes responsibility of the Clinical Operations function with respect to financial planning/forecasting and budget management, timeline development and tracking, and assessing and communicating resource needs for respective programs to CMO as appropriate.
Responsibilities:
Assist in the development of operational strategy and clinical operation plans in support of Walden’s Clinical Development strategy.
Develop and oversee clinical operations department forecast and portfolios.
Serve as Clinical Program Lead on our Clinical Programs.
Oversee clinical trials, budgets, timelines, and resources assuring quality and operational focus to achieve established objectives.
Drive Clinical Operations team progress to align with departmental and corporate goals
Organize and drive department meeting content and follow-up including lessons learned, risk assessments and clinical portfolio reviews from a governance oversight level as needed
Partner and collaborate with cross-functional stakeholders including Project Leaders, and other relevant stakeholders.
Lead the evaluation, selection, oversight, and management of vendors including CROs and external consultants as appropriate.
Interface with external vendors and study team(s) for escalation issues.
Develop, implement, and manage SOP’s assuring compliance.
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate.
Provide insight and expertise on cross-functional project teams and vendor/CRO operational meeting ensuring compliance with operational standards and procedures.
Represent Walden to investigators, site staff, and key opinion leaders (on an as-needed basis).
Perform and document study level Sponsor Oversight of outsourced clinical activities.
Review KPI’s with CRO’s and identify, resolve and/or escalate issues as appropriate.
Communicate study-status, cost, and issues to ensure timely decision-making by senior management.
Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct.
Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance.
Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives.
Develop and foster strong, collaborative relationships with key stakeholders both within and external to Walden.
Strive for continuous improvement and more efficient ways of working in clinical development.
Act as a role model for Walden’s values of Data, Innovation, Teamwork, Agility, Perseverance, and Fun.
Qualifications:
Minimum of BA/BS with at least 10 years of trial and clinical program experience. Advanced degree preferred.
Experience in renal diseases highly desired.
Solid experience in early and late phase drug development, including experience in managing adaptive clinical trials.
Experience in growing and leading clinical operations groups, including related functions such as data management.
Comfort with and track record of success at venture-backed start-up biopharmaceutical companies.
Cross-Collaboration proficiency with other functions (e.g., Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management)
Experience in GCP inspections/audits.
Outstanding verbal and written communication skills, in addition to excellent organizational skills.
Proven track record of effective leadership, developing personnel, and team-building skills, managing cross-functional teams in the context of a multi-disciplinary team in the biotech or pharmaceutical industry.
Resilient, creative, capable problem-solver.
Excellent organizational skills and ability to work independently.
Experience in establishing and maintaining relationships with key opinion leaders.
Some travel required.
About us:
Based in the heart of Cambridge, MA, Walden Biosciences is developing first-in-class, highly targeted therapies for individuals living with chronic kidney diseases (CKD). Our approach is different--we utilize a deep mechanistic understanding of kidney function in health and disease, knowledge of novel biological pathways critical in regulating kidney function and take a systems-based approach to translation into drug development. Our goal is to provide patients with novel, effective, and safe treatment options where currently few effective options exist for several rare and common diseases which are responsible for chronic kidney disease initiation and progression.
Our culture is collaborative, entrepreneurial and is driven by data and innovation. Our team is dynamic and has a successful track record in drug discovery. We strive to make the best decisions with the best available information, lead by example, and bring transformative medicines to patients in need.