Director, Therapeutic Area Clinical Operations Lead
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
- Sr. Clinical Operations Lead has budget responsibility over $35Million/year, accountability for delivery in high volume (# of studies) therapeutic areas and increased management responsibility - four or more Clinical Program Managers reporting to them with complex and highly visible clinical programs.
- Sr. Clinical Operations Lead has the ability to go across multiple assets with limited oversight.
- Provides clinical operations strategic leadership to, and management of all clinical programs within a designated Therapeutic Area (s) to ensure they are successfully planned, implemented and completed in accordance with the Company strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
- Champions the Clinical Research Program(s), keeping abreast of pertinent developments in the therapeutic area including regulatory strategies and competitor status.
- Act as the primary interface with the CSD Therapeutic Area Head with respect to Clinical Operations (including program timelines; budgets; and protocol development).
- Standing member of all Core Project Teams within designated Therapeutic Areas
- Primary interface for key stakeholders (Regulatory/Commercial Operations/Commercial Development/Project Management) regarding operational delivery of clinical programs within a designated Therapeutic Area
- Manage key program risks and escalate to senior management as appropriate
- Provides operational input to the Clinical Development Plan (including assessing the feasibility) and contributes to the overall program(s) strategy planning and implementation.
- Drives the implementation of the clinical development plan within CRD to achieve program timelines.
- Responsible for overall forecasts and management of clinical program(s) budgets and resource allocation in collaboration with the primary budget responsible member of the Clinical Operations team and Head of Clinical Operations.
- Ensures clinical program is in compliance with ICH GCP, SOPs and regulatory requirements.
- In collaboration with Clinical Development Personnel and Regional Clinical Operations Personnel, establishes and maintains links with investigators and key opinion leaders and appropriate professional bodies in the therapeutic area.
- Manages a team of Clinical Program Managers and Clinical Study Managers, with responsibility for their development, coaching and mentoring.
- Where required:
- Attends and participates in discussions with regulatory agencies
- Attends and participates in Clinical Development Plan Sub-Committee meetings
- Reviews Package Inserts
- Reports to: Sr. Director, Clinical Operations
- Matrix Environment: Interfaces with Head Clinical Operations Regions, Head Global Clinical Supply & Logistics, TA Sr. Directors, Directors, Sr. Managers, Managers, and Medical Writers. Also interfaces with Core Project Team (Core Project Manager), Clinical Services, and Clinical Quality Assurance (CQA).
- Direct reports may include Clinical Program Managers, Clinical Study Managers, and/or non-management staff.
Main Responsibilities and Accountabilities:
1. Builds and leads a dedicated clinical operations team for a designated Therapeutic Area. Provides leadership and direction to the clinical operations team allocated to the implementation of a given clinical development program.
In collaboration with Clinical Development personnel, prepares detailed global clinical development program plans detailing key information e.g. outlining of the program goal/key objectives, strategies, timelines/milestones, resource implications. Ensures that these plans are aligned with those of the multidisciplinary Core Project Team. Provides operational expertise in the design of clinical program(s).
2. Upholds and promotes the Company’s reputation externally by demonstrating high professional standards and integrity in all external contacts.
Ensures clinical programs are conducted in compliance with SOPs, GCP, and ICH/FDA/EMEA and local HA regulations, while also ensuring project status is tracked and project timelines are met.
Maintains up to date knowledge of the therapeutic area/product candidate(s); clinical practice, competitors, and regulatory considerations.
3. Acts as the primary point of contact between the Clinical Research Department/Team /CRO and the relevant multidisciplinary Project Team Leader(s).
In collaboration with Clinical Development, maintains excellent communication and build positive working relationships with investigators, key opinion leaders, local and overseas collaborators, external customers and other CSL staff.
Consults with internal and external medical/scientific researchers.
4. Forecasts and manages program-related expenditure.
Provides support to CPMs in the negotiation of financial and administrative arrangements with external parties (e.g. Investigators, Contract Research Organizations) and also internally within CSL.
5. Primarily responsible for the management of key clinical documents for a given program (including Protocols; Statistical Analysis Plans; Clinical Study Reports), including QC review these documents.
Provides input into study clinical operations documents.
6. Assigns follow-up coordinator responsibility to CPMs for CQA audit and inspection reports within responsible program(s).
Ensures findings related to clinical operations activities are resolved and corrective action and preventative action plans (CAPA) for these findings are implemented. Evaluates effectiveness of clinical operations CAPA plans. In collaboration with follow-up coordinators, may also identify systemic audit findings for which clinical operations is not responsible and works with TA’s, Clinical Services, and other involved departments to resolve and implement a CAPA plan for these findings. Participates in inspection readiness activities.
7. Supervises staff activities concerning clinical operations activities. Oversees clinical studies defined in the Clinical Development Plan. Organizes actions and resources to meet projected deadlines while maintaining quality standards.
Provides support to the CPMs in matrix management of other clinical team members (e.g. RSMs, CRAs). May also function as a mentor to Clinical Operations Sr. Managers and Managers.
8. Maximizes the use of human and fiscal resources through effective planning. Calculates manpower and cost projections. Partners with the Therapeutic Area Director, CSD, to obtain required resources to support clinical programs. Supervises, develops and evaluates internal clinical operations staff. Assesses the activity/ performance of team members and/or subordinates by establishing objectives, and conducting performance appraisals for team members.
9. Ensures on track for all clinical studies within TA Holds staff accountable to appropriate CRO oversight
Evaluates adequacy of CROs in collaboration with CSLB Clinical Services and CQA.
Reviews evaluations and requests for proposal (RFP) and makes recommendations for CRO selection. Oversees contractors and CRA/CRO team, including data management partners.
Assesses the activity/ performance of CRO/ CRA team and contractors by establishing objectives, and performing qualitative assessments of activities.
10. Actively drives the development and implementation of global clinical operations processes and procedures. Ensures staff is effectively trained and follows global clinical operations processes.
Ensures lessons learned are captured for all clinical programs across the Therapeutic Area and influences future process improvement.
Position Qualifications and Experience Requirements:
A minimum undergraduate degree in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
• As a guide, a minimum of 8+ years’ relevant clinical research (or related) experience within the pharmaceutical industry.
• Track record of 5+ years leading and managing a team of professional staff.
• Proven capability to lead multiple assets.
• A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
• Budget forecasting and management.
• Thorough knowledge of ICH GCP and its applicability to all stages of the clinical development process
Desired Attributes - The following are considered desirable:
• Postgraduate qualifications.
• Experience in scientific/medical research.
• Specialist knowledge e.g. immunology, coagulation disorders, pulmonology, virology, oncology and cardiology.
• Demonstrated proficiency in advanced MS Project.
• Experience in overseeing Global Clinical Trials (pharmaceutical or research institute).
• Demonstrated ability to lead teams and work in a fast-paced team environment. Possesses drive, energy and enthusiasm to deliver the program objectives.
• Ability to understand 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.
• 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 regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
• Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
• Extensive and comprehensive knowledge of international GCP guidelines.
• Ability to evaluate, judge and make recommendations regarding staff. Ability to assist in teaching/coaching and setting an example of ‘best practice’.
• Excellent interpersonal and decision making skills. Demonstrates innovation.
• Maintains current medical/scientific/regulatory knowledge.
• Excellent written and oral communication skills.
• Maintains computer literacy in appropriate software.