Senior Director, Clinical Program Lead, elacestrant

Menarini Stemline; New York (NY); On-site; USD 260,000 - 300,000; Full time

Job summary

Menarini Stemline is seeking a Senior Director, Clinical Program Lead for the Elacestrant Program. This senior role involves overseeing clinical operations, managing timelines and budgets, and ensuring compliance with regulatory standards. Ideal candidates will have extensive experience in oncology clinical trials and strong leadership skills in project management.

Benefits

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

Qualifications

• Minimum 15 years of experience in drug development and clinical research.
• 10+ years in Clinical Operations for Oncology studies preferred.
• Demonstrated project/program management skills.

Responsibilities

• Develops operational plans for the Elacestrant program.
• Leads Clinical Operation team including managing CROs and vendors.
• Ensures compliance with regulatory requirements.

Skills

Project management

Risk assessment

Communication skills

Negotiation skills

Analytical skills

Decision making

Interpersonal skills

Education

BS/BA degree in a scientific or health-related discipline

Advanced scientific or equivalent experience preferred

Job description

Senior Director, Clinical Program Lead, elacestrant

Join to apply for the Senior Director, Clinical Program Lead, elacestrant role at Menarini Stemline

Senior Director, Clinical Program Lead, elacestrant

Join to apply for the Senior Director, Clinical Program Lead, elacestrant role at Menarini Stemline

This range is provided by Menarini Stemline. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$260,000.00/yr - $300,000.00/yr

Senior Director, Clinical Operations Program Lead, elacestrant

Reports to VP of Clinical Operations

Reporting to the Vice President of Clinical Operations, this role will be responsible for the project management of all aspects of Clinical Operations for the Elacestrant Program in Breast Cancer. Key accountability includes successful conduct of all clinical trials in the program, consistent with applicable regulations, guidelines, and procedures, as well as managing clinical project timelines, budgets, deliverables, communications. Serves as main point of contact for functional issues, including any CRO/ vendor performance issues and Clinical Program Team resource issues and is the line manager of Clinical Trial Leaders working within the program.

Responsibilities

• Develops and coordinates operational plans for the Elacestrant program (i.e. study timeline projection, drug forecast, safety plan, monitoring plan, study management plan).
• Ensures project leadership personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements.
• 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.
• Assesses and manages resource allocations on assigned project to ensure that established cost, time, and quality goals are met.
• Acts as line manager to Clinical Program Leads and other team as assigned.
• Provides technical support and guidance (including project definition, risk identification, escalation and mitigation, resource planning, goals and deliverables) the full team working within the assigned program.
• Identifies and escalates impacts to project scope, resources, schedule or budget through standard methods.
• Understands and manages project/program inter-dependencies to achieve program milestones/deliverables.
• Conducts evaluations and implements required changes for all projects (including mid-project recovery of at risk projects, re-scoping, postponement, or cancellation).
• Measures and reports KPIs and leads continuous improvement.
• Manages workload of supervised staff with continued assessment and adjustment as needed.
• Provides on-going feedback, development and coaching of direct reports and program team.
• 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.
• Ensures consistency, accuracy and integrity of all clinical data across the Elacestrant programs.
• 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.
• 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.
• Promotes effective partnership among cross-functional teams and provides 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.

Qualifications

• BS/BA degree in a scientific or health related discipline. Advanced scientific or equivalent experience preferred.
• Minimum of 15 years if experience in drug development, clinical research and operational strategy experience 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).
• 10+ years of experience should be directly in the Clinical Operations function for Oncology studies. Breast cancer studies strongly preferred.
• 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.
• Direct work experience in a global, cross-functional project management environment.
• Executive presence with ability to confidently deliver complex presentations to senior management.
• High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective.
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency.
• Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills.
• Excellent communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.
• Experience planning and delivering 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.

Menarini Stemline is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Science

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

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