Archie Hale

• Therapeutic Area: Haemato-Oncology
• Indications: AML, MCL, CLL, Hodgkins Lymphoma

Achievements

Responsibilities

• Strengthened relationships with vendors and partners contributing positively towards timely completion of tasks.
• Led project teams to successful delivery of complex programmes.
• Identified programme risks, mitigated potential impact on deliverables.
• Coordinated cross-functional teams for effective programme execution.
• Managed stakeholder relationships to foster alignment and commitment.
• Developed strategic plans, ensured programme alignment with organisational goals.
• Implemented process improvements by streamlining existing procedures.
• Synchronised programme activities, achieved desired objectives within given timeline.
• Ensured quality control measures for superior output in all projects.
• Facilitated communication amongst team members, enhanced collaboration and productivity.
• Conducted regular progress reviews with stakeholders ensuring transparency and trust-building.
• Drove change management initiatives in response to evolving business needs.
• Responsible for lifecycle management one of AZ Haem assets
• Clinical Delivery Lead for all submission activities for 4 registrational trials
• Change Management Functional Lead for transition of Document Management from ANGEL CARA to ERV system for submission, review, approval and publishing of regulatory documents
• Matrix management/ oversight of team of Global Associate Directors and Study Directors and their teams
• Present status of program at senior Leadership Meetings, including new proposals, budget or timeline changes
• Input to planning meetings, including budget planning and timeline management with view to regulatory and commercial imperatives
• Input to Briefing Booklets for FDA
• Co-ordinate update of regulatory documents: IB, PBER, DSUR, PRIF etc
• Help prepare business case around new studies as well as leverage subject matter expertise to set up operational plan for new study in program in strategic manner
• Partner closely with clinical development team to look at study design with foresight and strategic thinking, coming up with options and recommendations

• Therapeutic Area: Oncology
• Indications: NSCLC, Melanoma, Renal, Bladder, HNSCC, TNBC

Achievements

Responsibilities

• Managed team dynamics by implementing conflict resolution strategies.
• Boosted department efficiency by streamlining operational processes.
• Supervised project timelines for timely completion.
• Implemented cost reduction measures, reduced overhead expenses.
• Coordinated cross-departmental collaboration for improved workflow.
• Led performance reviews, identified areas for improvement.
• Streamlined communication channels, enhanced internal information flow.
• Delegated tasks efficiently to maximise productivity.
• Piloted change management initiatives successfully improving organisational adaptability.
• Handled negotiations with outside vendors and service agencies to meet group needs.
• Organised financial and operational data to help with yearly budgeting and planning.
• Established clear budgets and cost controls strategies to meet objectives.
• Translated senior management directives into actionable front-line policies and implemented changes with staff.
• Managed team of PM/ junior PM supporting ongoing and new indications within this platform, working to manage MAP program globally
• Led overall initiation, coordination, implementation and management of international clinical trials from start-up to close out
• Manage operational and technical aspects of projects including budgeting, study initiation and risk management
• Anticipate potential issues and risks within clinical program, create contingency plans and drive solution implementation
• Select, manage and coordinate external vendors
• Monitor vendor performance and ensure continuous oversight - Represent clinical operations on multi-function project teams internally and externally

• Area: Respiratory
• Indications: COPD, Cystic Fibrosis, COVID-19

Achievements and Responsibilities

• Improved operational efficiency by streamlining processes and procedures.
• Developed and implemented strategic plans to enhance business operations.
• Collaborated with cross-functional teams for successful project completion.
• Ensured consistent service delivery with effective quality control measures.
• Conducted regular audits to ensure regulatory compliance.
• Led team meetings, promoting clear communication and collaboration.
• Trained staff members in new operational procedures for increased productivity.
• Managed change initiatives, ensuring minimal disruption to operations.
• Created detailed reports on operational performance against targets.
• Streamlined workflow processes to improve efficiency and reduce costs.
• Solved complex problems through critical thinking and analytical skills.
• Played integral role in development of organisational policies and procedures.
• Encouraged development of clear objectives and action plans.
• Drafted procedure manuals, work definitions and standard operating procedures by job title or work area.
• Conducted studies focused on analysing current strategies and evaluating feasibility and potential results of proposals.
• Support development of internal Clinical Operations strategy
• Managed strategic aspects of projects; identify, analyse, minimize/mitigate any risks, including implications of different technical and operational choices
• Identified needs, liaised with key stakeholder and evaluated alternative business solutions and strategies
• Responsible and accountable for conduct of all clinical trials.
• Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance, and study protocol
• Designed and implemented SOPs for clinical operations/other internal stakeholder functions; and contribute to review/development of procedures, guidelines, SOPs, metrics, etc
• Ensure 30 Holdings are inspection ready for GCP or other regulatory audits
• Support, relationship management of supplier/vendor network

• Therapeutic Area: Oncology (Radioimmunotherapy and Diagnostics)
• Indications: All Solid Tumours

Achievements and Responsibilities

• Wrote all Clinical SOPs adhering to regulatory guidance of FDA, EMA and MHRA and made company Inspection ready/ developed GDPR framework
• Oversaw, led, and managed team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality
• Coordination/execution of all operational aspects of clinical studies (including identification, management of vendors, availability of clinical supplies at sites, review and approval of requests for investigational test articles)
• Identify, qualify, audit, and manage all external vendors, including CROs ie. take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make appropriate changes in order to ensure trial conduct is completed in compliance and meets company's business objectives
• Worked collaboratively with cross functional external resource including regulatory - affairs, medical writing and biostatistics
• Ensured clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance, and study protocol
• Identified, qualified, managed, and maintained relations with clinical trial sites, including collaborating with Principal Investigators on developing robust study protocols, drive site selection, and patient recruitment programs that delivered enrolment targets

• Therapeutic Area: Oncology
• Indications: All Solid Tumours

Responsibilities and achievements

• Development and driving through of the clinical operations program in conjunction with other members of Macrophage Pharma team, including writing clinical and non-clinical SOPs, inspection readiness, GDPR risk assessment, input into Clinical Development Plan and into scientific briefing documents
• Oversaw the successful delivery of key projects, ensuring adherence to established timelines and budgets.
• Fostered a highly collaborative team environment to optimise project outcomes.
• Established effective communication channels, fostering strong relationships amongst cross-functional teams.
• Orchestrated change management initiatives to improve organisational culture and employee engagement.
• Negotiated contracts with vendors and suppliers that facilitated significant cost savings.
• Worked closely with executive leadership, providing insightful inputs on strategy formulation.
• Budget development and management and oversight of site budget and contract negotiation process
• Project reporting to the Executive team, including identification of risks and contingencies
• Set up and maintenance of internal GCP compliant quality system and participation in internal and external audits
• Oversight and assistance in the preparation, review and approval of documents (e.g Vendor agreements, protocols, information sheets and consent forms, case report forms, investigational Medicinal Product labelling, sections of Investigator Brochures, ethics submission documents and study reports)
• Identification, assessment and management of external service providers throughout the life of assigned clinical trials
• Oversight of investigative sites' adherence to regulations
• Lead review of data to ensure quality and consistency
• Plan and conduct investigator meetings and advisory boards

• Therapeutic Area: Oncology
• Indications: Prostate cancer

Responsibilities and achievements

• Managed all aspects of assigned post marketing initiatives, including writing and driving through several governance steps, a regulatory mandated post marketing protocol; thereby forestalling the total ban on sales in that region
• Oversight of study delivery of large registry, including ensuring patient enrolment met target of up to 2000 patients enrolled
• Remedial work carried out on long running and costly post marketing registry delivering poor data and value. Renegotiated contract with CRO, delivered cost savings and regular data cuts offering good quality data for publications
• Led the cross-functional study team and oversaw the progress and delivery of their individual activities within timelines and budgets, whilst reporting progress to senior leadership
• Streamlined operational processes to improve efficiency.
• Managed complex projects, ensuring successful delivery on time.
• Fostered strong relationships with key stakeholders for improved collaboration.
• Achieved organisational objectives by developing comprehensive strategic plans.
• Implemented cost reduction measures to increase profitability.
• Coordinated cross-functional teams, facilitating seamless project execution.
• Enhanced company reputation by maintaining high standards of corporate governance.
• Built key stakeholder relationships to foster collaboration and partnerships.
• Encouraged open communication channels, boosting internal transparency and trust among team members.
• Coordinated with senior management to communicate and execute strategic directives.
• Managed and supervised team members, providing mentorship and guidance.

• Therapeutic Area: Oncology
• Indications: AML, non small cell lung cancer and follicular lymphoma

Responsibilities

• Managed overall operation of clinical studies for the UK:
• Provided leadership and local strategic planning and organization skills to ensure the effective and efficient delivery of operational aspects of one or more studies through all phases of study management (preparation, conduct, close-out), in accordance with the appropriate quality standards including ICH/GCP/GPP standards, Roche SOPs, local operating guidelines and local requirements, as applicable
• For Global/Regional the CSM led and had full accountability (time, quality, cost) of all Affiliate related aspects of a study, ensured delivery of country/regional operational aspects in alignment with the study plans provided by the global SMT
• For Local Studies, the CSM acted as study leader and, in addition to the above, provided the leadership and clinical operational expertise for local study team.

• Area: Oncology
• Indication: Glioma and HCC

Responsibilities

• Managed overall operation of clinical studies or clinical projects including project planning, budget, resource management and contract research organization management within the overall context of an approved clinical operational plan
• Responsible for managing full scope of study(ies), including protocol development, conduct of study, data collection, and completion of study report
• Developed study-related documents and assured compliance with good clinical practices and regulatory guidelines
• Recommended and implemented innovative process ideas to impact clinical trials management
• Act as a cross functional liaison to ensure study plan aligns with business development strategies

Key points :

• Ran Phase I single ascending dose and Phase Ib/II MTD in glioma studies using chemotherapeutic microspheres; including safety monitoring, writing safety narratives and close liaison with surgeons implementing protocols in this rare disease.
• Managed close out of studies for safety reasons
• Wrote protocol for Phase I FTIH dose escalation/ de-escalation study in hepatocellular carcinoma using radiolabelled microspheres loaded with tyrosine kinase inhibitor by close liaison with pre-clinical scientists
• Matrix management of study teams

• Therapeutic Area: Neurology/ Haematology
• Indications: Multiple Sclerosis / Haemophilia

Achievements

Responsibilities

• Improved workflow with strategic delegation of tasks.
• Developed comprehensive operational plans to optimise performance.
• Streamlined operations by implementing efficient management processes.
• Orchestrated team training for improved operational efficiency.
• Achieved process continuity by coordinating cross-functional teams.
• Implemented risk mitigation strategies to prevent operational disruptions.
• Facilitated regular team meetings to encourage open communication and collaboration.
• Ensured compliance with industry regulations, maintaining high-quality standards throughout operations.
• Led change management initiatives, resulting in smoother transitions during restructuring phases.
• Created detailed reports on operational performance, providing valuable insights for decision making.
• Specialist in setting up and running phase 1-3 trials in China, Japan and Australia, with emphasis on registration trials to enable submission for Marketing Authorisation
• Strategic oversight of global MS and haemophilia trials according to clinical development plan, including input into protocols and set-up of study teams
• Input into and development of clinical development plans
• Protocol and ICF development and approval
• CSR development
• Vendor/CRO selection and management
• CRA training
• Organise and present at Investigator Meetings
• Delivery of projects to timelines and within budget
• Project teams' management
• Attendance and input into Clinical Development and Program Team meetings
• Mentor other COLs
• Mentor CTCS and CTAs
• Lifecycle management
• Key points :
• Phase I bridging study in MS evaluating Fampridine in chinese patients, conducted in Hong Kong
• Phase 1 FTIH study in MS using Humanized mAb against tumor necrosis factor (TNF)- like weak inducer of apoptosis (TWEAK)
• Multiple phase II and III studies in MS with Avonex, Tysabri, Tecfidera and Fampyra
• Paediatric registration studies in haemophilia A and B with Alprolix and Eloctate
• Mixture of biologics and small molecules
• Cross-functional matrix management
• Analysed operations metrics and tracked KPIs to support data-driven business strategies.
• Oversaw daily operations to fulfil established objectives and proactively address challenges.
• Built strong rapport with internal and external stakeholders, representing organisation with professionalism.
• Enforced adherence to quality, safety and performance metrics to keep teams in compliance with all requirements.
• Translated senior management directives into actionable front-line policies and implemented changes with staff.

• Therapeutic Area: Ophthalmology and Genitourinary
• Indication: Glaucoma, Macular Degeneration and Overactive Bladder

Responsibilities

• All start-up activities for multiple projects: - the logistical tasks associated with the preparation, collation and review of the regulatory documents submission package
• Draft and review/approve Study ICFs
• Development of the Country-specific Informed Consent template
• Review of drug release documents; release IP in electronic system based on review and approval of essential documents; responsible for on-going regulatory documents maintenance
• Preparation, review, confirmation and distribution of the draft Clinical Trial Agreement and Budget to Site
• Negotiation with site on budget costs and contract language
• Responsible for final execution of the contract
• Co-ordinate EC submissions, update of CTMS with EC submission and approval dates, collate responses to EC and regulatory questions, in collaboration with study team
• Responsible for mMultiple phase II and III studies using Botox (biologic) and Lumigan (small molecule).

• Therapeutic Area: Genitourinary
• Indication: Overactive Bladder

Responsibilities

• Retrospective review of monitoring reports and associated documents for a completed global study with 185 sites
• Advice on how to make sites inspection ready
• Co-ordination with QA department to include audit findings into inspection readiness guidance
• Liaison with study managers and CRAs to implement review findings
• Review and approval of inspection readiness packages
• Provide expert advice on quality issues
• Co-monitoring visits to “problem” sites to ensure inspection readiness and review quality of data
• Team leader and spokesperson for 3 other QC experts.

• Therapeutic Area: Neurology
• Indication: Epilepsy

Responsibilities

• Set-up of 2 double-blind randomised studies (70 sites, 300 subjects across 15 countries), and 2 open label extension studies to follow on from pivotal studies
• Protocol and ICF writing and approval
• Involvement in RFP and bid defences
• Vendor/CRO selection and management
• CRA training
• Organise and present at Investigator Meeting
• Delivery of projects to timelines and within budget
• Manage program budget
• Provide strategic input into Japan CDT including PIP
• Project team management (Pan-European and Australia)
• Compliance with regulatory, Standard Operating Procedures (SOPs), ICH Good Clinical
• Practice (ICH GCP) and project requirements
• Key points:
• Phase III and extension studies in paediatric patients with epilepsy evaluating zonisamide (small molecule)
• Cross functional matrix management of large team

Multiple projects for different customers, implementing Phase I to IV projects

• Departmental process improvement and promoter of effective change
• Managed the development, implementation, and evaluation of complex clinical research studies to improve health outcomes.
• Developed detailed project plans for efficient execution and timely completion of clinical trials.
• Reduced operational inefficiencies with strategic resource allocation in clinical projects.
• Liaised with stakeholders, ensuring clear communication across multi-disciplinary teams.
• Streamlined data collection processes for enhanced accuracy in clinical research results.
• Ensured regulatory compliance for all clinical projects to maintain high industry standards.
• Collaborated with medical professionals, contributing to successful clinical trial design and execution.
• Oversaw risk assessments throughout project lifecycle, effectively mitigating potential issues.
• Conducted thorough feasibility studies for proposed clinical projects, aiding decision-making processes.
• Coordinated timely submission of essential documents to ethics committees, supporting regulatory compliance efforts.
• Delivery of projects to timelines and within budget
• Project team management
• Customer satisfaction and repeat business
• Compliance with regulatory, Standard Operating Procedures (SOPs), ICH Good Clinical
• Practice (ICH GCP) and project requirements

• Development and management of phase III program for a GI product:
• Overall Project Management, including managing study team and conducting team meetings
• Strategic input to development program
• Wrote Clinical Development Plan CDP)
• Wrote Target Product Profile (TPP)
• Conducted Feasibility
• Protocol development
• CRF development
• CRO selection and management
• Managed Study budget
• Input to BLA
• Involvement in pre-launch activities
• Key points:
• Registration studies in patients with Crohns disease and ulcerative colitis evaluating certolizumab
• Cross functional matrix management of large teams

• Medical Affairs Department
• Start up activities on phase IV SAMM study for a respiratory product including:
• Developed Project Management Plan
• Developed Clinical Development Plan
• Developed and implemented Feasibility
• Protocol writing, GP letter, ICF eCRF development
• Selected multiple UK sites
• CRO selection and technical liaison for device and drug
• Organised and ran virtual Investigator meetings
• Implementation of study at site

• Facilitated the implementation of PGx capabilities, procedures and processes into clinical development studies
• Assisted in the completion of PGx protocols and consents to ensure the appropriate PGx content
• Attended clinical working group meetings to address questions and issues concerning the application of PGx in clinical development studies
• Interfaced with Clinical, Biomedical Data Sciences, Regulatory and Compliance groups to address PGx project specific questions
• Generated presentations relevant to PGx operations for internal (e.g., Clinical Operations) and external (e.g., Investigators) stakeholders
• Trained MDC and ClinOps staff in new PGx SOPs and processes, on an ongoing basis.

Temporary assignment to gain commercial experience

• Target Territory Business Sales of £4 M from 4 units (Guys, Kings, St George's, St Helier) and associated satellites
• Strengthened key client relationships by developing tailored account strategies.
• Secured long-term customer loyalty with excellent service and understanding of client needs.
• Negotiated profitable contracts to ensure mutual benefit.
• Delivered presentations, secured new partnerships.
• Developed multi-level contacts within key accounts to enhance communication channels.
• Cultivated a deep understanding of client businesses with thorough research and consistent engagement.
• Formulated strategic plans to increase product visibility and market share.
• Maintained detailed knowledge of industry trends, positioned products effectively in the market.
• Customer Relationship Management
• Account Management and development
• Capture new business and keep existing
• Act as key contact for units and Novartis management

Responsibilities

• Protocol writing, clinical report writing and case record form design of Phase IV studies
• Advising on the suitability of international study designs for UK participation
• Providing transplant specific therapeutic training and trial protocol training of Clinical Research Associates
• Advising within an international team on the clinical development of a new immunosuppressive compound
• Providing marketing support eg Visiting units with sales representatives, providing promotional material
• Providing budget estimates for marketing support of Phase IV studies
• Attending transplant conferences and representing Novartis to customers
• Involvement in launch of C2 campaign and use of Simulect as an adjunctive therapy
• Key points:
• Management of cross functional team and CRAs
• Multiple post marketing studies and lifecycle management of cyclosporin and basiliximab
• Advice and support for sales staff.

• To provide and oversee an efficient process to resource all projects with a clinical component, in conjunction with local heads of clinical operations, and business developers
• Aid in the development and manage rollout and training of a Pan - European Resourcing database
• European Project Management of the Q Online Knowledge Management System
• Aid in the development of processes to improve efficiency within Clinical Operations by participation in global task forces
• Key points:
• Line management of 3 process development administrators
• Liaison across varied and multiple functions, including HR, IT, Business Development as well as clinical operations

Therapeutic area: Diabetes

• Management of all aspects of a pivotal global phase IIIa trial in Germany, Austria and Czech Republic - included ensuring trials were conducted to ICH GCP standards, auditing sites and monitors, conduct of trial within budget, financial management, project tracking and general trouble-shooting
• Key points:
• Management of cross functional team and CRAs
• Mentoring of junior staff

Therapeutic area : oncology

Indication: Breast cancer

• Management of all aspects of a phase III open-label comparative trial including payments, site management, post-study follow-up, serious adverse events and production of listings /reports for eventual publication
• Production of QoL data
• Wrap up budgets
• Finance reconciliation

Therapeutic area : oncology

Indication: Neuroendocrine tumours and prostate cancer

Responsibilities

• Management of all aspects of phase II/III trials, including routine monitoring activities to GCP guidelines, within the UK and Switzerland
• Other aspects included maintenance of study files at investigator and client sites to GCP standards, liaison with regulatory affairs regarding SAE reports and CTX extensions, liaison with finance department regarding payment to sites and contractual issues, obtaining ethics committee approval, closure of sites and all other activities involved in bringing studies to a satisfactory conclusion for the client
• Kick start neuroendocrine tumour study (rare disease) to complete recruitment within time, quality standards and budget to deliver quality data for analysis

Data Management of Multiple myeloma, ovarian tumours and breast cancer studies, including query generation and management

Collection, reporting of safety data from all investigational and commercial sites

• Carried out day-to-day duties accurately and efficiently.
• Quickly learned and applied new skills to daily tasks, improving efficiency and productivity.
• Successfully delivered on tasks within tight deadlines.
• Demonstrated respect, friendliness and willingness to help wherever needed.

• Line management of 2 marketing assistants