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CSL · 1 day ago

Associate Director, Clinical Operations Lead

Americas, US-PA, King of Prussia, CSL Behring

Full-time

Onsite

Lead/Staff, Director/Executive

10+ years exp

CSL Behring is a global biotherapeutics leader focused on developing innovative therapies for patients. The Associate Director Clinical Operations Lead is responsible for the operational strategy and management of clinical studies, ensuring efficient execution and collaboration across teams and stakeholders.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Responsibilities

Design and implement operational strategies, study management plans, and supporting documentation to drive study efficiency and quality (more complex studies). Continuously assess and improve clinical operations processes. Provide early input in CDP and study outline

Lead cross-functional study teams, coordinate with functional area representatives, and ensure timely execution of all study-related activities. Responsible for vendor selection/management/oversight, issue escalation, and inspection readiness

Lead and coordinate cross-functional teams, fostering collaboration among internal and external stakeholders (including vendors, investigators, and regulatory authorities). Act as the primary point of contact for all study-related matters, build and maintain strong relationships, mentor and support team members, and represent the study team in communications with senior management. Act in an advisory capacity to other clinops colleagues and ensure knowledge sharing across therapeutic areas

Forecast, manage, and report on study budgets and key performance metrics, including study start-up, enrollment, and data collection timeliness/quality

Plan, manage, and execute more complex global clinical studies from protocol development through to Clinical Study Report (CSR) completion and Trial Master File (TMF) archiving. Oversee timelines, budgets, regulatory/GCP compliance, feasibility, country strategy, enrollment plans, and risk mitigation

Act as the primary point of contact both internally and externally (e.g., vendors) as applicable for anything study related

Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations

Support audits/inspections and resolutions of findings

Support in the development of new SOPs, guidelines etc and/or participate in working groups about new processes

Functional leadership and mentorship of junior staff required; Act in advisory capacity to other clinops colleagues within and across TAs

When accountable to a set of studies and/or program(s) provides oversight and direction, ensuring appropriate delegation and delivery, inter-program efficiencies and applied learnings

Qualification

Clinical Operations StrategyBudget ManagementClinical Trial OversightProject ManagementICH Guidelines/GCPClinical Research ExperienceTeam LeadershipInterpersonal SkillsDecision-Making SkillsMentoring SkillsProblem-Solving SkillsCommunication Skills

Required

At minimum, bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred

As a guide, a minimum of 10 years' relevant clinical research (or related) experience within the pharmaceutical industry

Previous experience in leading and managing a team of professional staff

A solid understanding of the drug development process, and specifically, each step within the clinical trial process

Experience in overseeing large and/or complex global clinical trials

Robust budget forecasting and management experience

Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process

Demonstrated ability to lead teams and work in a fast-paced team environment

Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment

Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities

Ability to evaluate, judge and make decisions regarding staff. Ability to teach/coaching and setting an example of ‘best practice'

Excellent interpersonal and decision-making skills

Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives

Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges

Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report

Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards

Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains current medical/scientific/regulatory knowledge

Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills

Demonstrated ability to problem solve and use clear judgment in relation to interactions with external parties, timelines, and complex clinical programs

Excellent written and oral communication skills and maintains computer literacy in appropriate software