Sr. Director/Director, Clinical Program Lead

Clinical Program Lead

Reports to: SVP, Global Clinical Operations & Medical Writing

Opportunity

Matrix leader of cross-functional Clinical Program Team responsible for operation for assigned clinical program(s). Key accountability includes successful conduct of clinical trials consistent with applicable regulations, guidelines, and procedures, as well as managing clinical project timelines, budgets, deliverables, communications and serves as main point of contact for functional issues, including any CRO/ vendor performance issues and Clinical Program Team resource issues. Also may serve as the line manager of junior members of the Clinical Operations team (CTA, CRA, CPM).

Reporting to the Senior Vice President of Clinical Operations, this role will be responsible for the clinical program management deliverables of assigned study(ies), in accordance with the agreed upon timelines, budget, and quality standards.

Responsibilities

• Manages multiple clinical studies/projects in parallel, through direct reports and/or vendors.
• Manages all aspects of study execution, with or without a CRO, including operational plans and timelines to achieve on-time enrollment and study completion.
• Promotes effective partnership among cross-functional teams and provide day to day direction for core team. Leads problem solving and resolution efforts.
• Provides dedicated and creative recommendations on how to meet goals and handle identified risks.
• Assists in the process of protocol finalization, using expertise to optimize trial design and execution, including Identification of barriers to timely and successful study execution and propose solutions to same, with regular reporting of study performance metrics.
• Develops and coordinates operational plans for a clinical study or multiple clinical studies within a development program (i.e. study timeline projection, drug forecast, safety plan, monitoring plan, study management plan).
• Leads the Clinical Operation team(s) including in-house team members and Contract Research Organizations (CROs), vendors and other suppliers to ensure work quality, timeliness and adherence to budget.
• Acts as a line manager for the Clinical Trial Assistant, Clinical Research Associate and Clinical Project Manager.Responsible for managing performance and career development of direct and/or indirect report(s).
• Drives clinical trial database construction, data collection, and assists with audits of data to ensure data integrity.
• Manages CRO and site budgets, communicates deviations from budget projections, and propose solutions for budget deviations.
• Assists with management and execution of site training and ongoing educational interventions to assure compliance with study protocols.
• Develops and actively manages clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets.
• Assists with Clinical Operations financial planning/forecasting and budget management and monitor the budget against actuals.
• Assures compliance with regulatory requirements by monitoring overall study compliance of CRO’s, vendors, etc. with company standard operating procedures (SOPs), GCP, FDA and applicable international regulations.
• Meets with team members on a regular basis regarding project tasks to ensure project operational milestones are met.
• Serves as primary project contact with vendors, including leading the proposal development and bid-defense process.

Skills/Knowledge

• BS/BA degree in a scientific or health related discipline. Advanced scientific or equivalent experience preferred.
• Minimum of 10 years experience in drug development, clinical research and operational strategy including responsibility for ensuring studies and programs are executed to quality, timelines and budget (at least part of this time in a Biotech/Pharma environment is preferred).
• Small biotechnology company experience a plus.
• Demonstrated project/program management skills including risk assessment, timeline and budget management and contingency planning.
• Line management experience including talent identification, development, coaching, performance management and resource allocation.
• Effective team leadership of matrix teams.
• Excellent communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.
• Experience across several complex therapeutic areas.
• Experience planning and delivering US based and global clinical programs and studies
• Multi-study experience managing early through late-stage clinical trials.
• Working knowledge of, and experience with, clinical trial conduct, GCPs and FDA Regulations.

Stemline Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Salary Range: $200,000 - $265,000