Philippa Hill
San Diego,CA
Summary
Seasoned clinical research executive leader with extensive cross functional clinical trial management and clinical operations experience. Demonstrated expertise in developing plans for clinical and operational feasibility and delivering results through streamlined operational execution. Industrious self-starter with ability to manage and complete projects independently or as part of a cross functional core team. Exceptional record of driving organizational development, financial performance, and growth. with a demonstrated history of strategically planning and tactically executing complex programs in the medical device industry. A diplomatic leader with a proven ability to develop and lead collaborative, multi-disciplinary, international teams and successfully execute challenging projects with tight time & budget constraints. Known for , leading by example, excellent cross-cultural communication and interpersonal skills, building solid relationships with internal and external teams, and developing and nurturing productive teams while successfully managing to bottom-line results.
Overview
18
18
years of professional experience
Work History
Independent Consultant
Philippa Hill Consulting
San Diego, CA
02.2015 - Current
- Supporting all aspects of Clinical Affairs/Operations /Education and Training
- Global Clinical Research Project Management
- Clinical Budget development for sponsor and study budgets and Contract Negotiations with vendors and Hospitals
- Strategic Analysis and Planning Organizational Leadership and Personnel Management
- Strong Global Clinical Experience
- Pre- Clinical engineering clinical design support (protocol development and case support for FIM)
- Scientific Committee Selection, Management (CEC/DSMB, SC )
- KOL relationship development in multiple clinical fields
- CRO and Core Lab Selection,contracting and management.
- Clinical trial planning and execution including study design, protocol writing, regulatory activities, preclinical, supplies management, site management, contracts and budget oversight, vendor and supplier management, site selection and qualification, site initiation visits, site monitoring, and compliance
- Clinical case support, on site continuing product training, education programs.
- Boost success of client's organization by improving performance, motivation, job satisfaction, hiring practices, training programs and management systems.
- Liaise with customers, management and sales team to better understand customer needs and recommend appropriate solutions.
- Oversee team development by hiring consulting professionals, allowing for increased clinical operations support and training team.
- Consummate professional when handling confidential customer business and operational information.
- Generate considerable cost savings for companies by renegotiating outsourcing contracts.
- Monitor and track costs and expenses to compare with original budget and identify failure points.
- Update stakeholders on key milestones for projects.
- Plan and execute investigator meetings, in both online and in-person formats.
- Perform as consultant for startup business in areas of clinical operations, logistics and training to various healthcare service professionals.
- Streamline operations by delivering recommendations for knowledge-base processes and procedures.
- Assist with identifying, interviewing and testing top talent to optimize productivity.
- Lead corrective action plans, procedure development, staff performance reviews and training programs.
- Provide personalized business consulting and overhaul services to strengthen client success.
- Develop complete business plans and operational strategies for new and existing business.
- Initiate success of client's organization by improving performance, hiring practices and management systems.
- Review internal systems and organized training plans to address areas in need of improvement..
- Deliver outstanding service to clients to maintain and extend relationship for future business opportunities.
Senior Director
DNAnexus
04.2019 - 03.2020
- Developed Data Services Clinical Study to support a HCP/Sponsor genomic study in Multiple Sclerosis
- Lead the Collaboration activities with Principal Investigators and site personnel, internal DNAnexus teams and 3rd party vendors that will provide high quality patient- derived clinical-genomic data
- Manages all clinical affairs activities, Including site selections, site activation, trial budgets, costs and site payments, CRF development and site training.
- Review contracts with legal counsel including Business Associate Agreements, Collaboration agreements, Material transfer agreements, Data Use Agreements and Master Participation Agreements
- Develop study protocols, informed consent forms, support regulatory submissions, develop electronics case report forms
- Ensure protocol compliance is followed
- Clinical study management including monitoring and data management
- Monitor multi-center observational Real-World Data studies to ensure that DNAnexus, the healthcare partners and vendor obligations are met and compliant with the study plan and applicable regulatory requirements
- Review Real world data collection via electronic health records, patient questionnaires, manual curation and imaging data
- Use Real World Data methodologies and clinical data models and processes to convert unstructured data to structured data by extracting key data points from clinical documents.
- Exercised appropriate cost control to meet budget restrictions.
Senior Director Clinical Affairs
ZOLL Circulation
San Jose, CA
08.2017 - 02.2019
- Provides direction and guidance in accordance with Good Clinical Practices, PMDA and FDA to employees in clinical trial research for new medical device and procedures for the treatment and cooling with patients with STEMI
- Manages all clinical affairs activities for the multiple european clinical studies, including site selections, site activation, trial budgets, costs and site payments.
- Manages the approval, direction, planning, execution, and interpretation of clinical trials/research and the data collection activities
- Managed trained and coached a US and EU headcount of up to 20 staff including CRA's and EU Project Managers via direct CRO's and independent consultants in up to 27 countries
- Oversight, selection, budget negotiation and management of vendors including CRO's and Core Labs
- Create immediate- to long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions deadlines
- Oversee proper collection of data and the development and maintenance of data systems
- Work with data management to analyze trial data and prepare documentation for submission to obtain clearance/approval for legal market distribution of medical devices
- Oversee Steering Committee and DSMB/CDMC meetings including providing presentation materials
- Work with senior management on business planning, clinical budget and succession planning
- Lead Clinical Affairs departments by developing, communicating, and building consensus for goals and programs that support division and company objectives.
- Prioritized and allocated valuable resources to meet business targets.
- Instituted formal operating procedures and enforced adherence to policies and regulations that impacted bottom-line.
- Met with department supervisors and provided staff support to attain organizational goals.
- Evaluated contracts and collaborated with legal counsel on negotiated improvements.
- Fostered work culture of collaboration and inclusion to increase morale and reduce turnover.
- Drove strategic improvements to enhance operational and organizational efficiencies.
- Spearheaded successful business development initiatives aligned with company's strategy and core competencies.
- Partnered with financial and customer operations teams to drive business transactions using customer data and Lean concepts.
Director Clinical Affairs
Intersection Medical, Inc
Carlsbad, CA
01.2014 - 02.2015
- Developed Clinical operations program from ground up,in a small start up. Identifying and hiring a clinical team of 5 for the organization as the project transferred from engineering and feasibility to first in man
- Provides direction and guidance in accordance with Good Clinical Practices to employees in clinical trial research for new medical device and procedures for the treatment of Acute Heart Failure Syndrome
- Manages the approval, direction, planning, execution, and interpretation of clinical trials/research and the data collection activities
- Develop a comprehensive interactive training and education system for this innovative device for use in Emergency Departments and Heart Failure critical care units
- Fostered excellence by example by "setting pace" and being hands on mentor to clinical staff. Orchestrated smooth and efficient program development by collaborating cross-functionally across departments.
- Create immediate- to long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions deadlines
- Established and maintained contacts at various management levels regarding clinical operations department and specific projects.
- Develop and manage budgets for Clinical department to meet organizational goals
- Lead Clinical Affairs departments by developing, communicating, and building consensus for goals and programs that support division and company objectives
- Oversee proper collection of clinical study data.
- Analyze data and prepare documentation for submission to obtain clearance/approval for legal market distribution of medical devices
- Attend relevant scientific and medical meetings
- Member of the senior leadership team
Senior Clinical Program Manager
Medtronic, Hospital Critical Care
Northridge, CA
04.2012 - 01.2014
- Designed and piloted large clinical education program for EU launch of CGM (Continuous Glucose Monitoring) system
- Provide onsite support and training for CGM launch and site follow up
- Provide leadership for early clinical CGM pilot studies and lead expansion of clinical service program
- Lead the expansion and training of clinical support staff in expanding EU markets.
- Trained over 1000 ICU Nurses and Physicians in use of CGM system in ICU's in UK and Germany.
- Provide consultation as product management representative at sites
- Compile and make recommendations based on input and feedback from customers to marketing and R&D, including: marketing trends, satisfaction, competitive information current and new product issues
- Attend medical and sales meetings
- Identify needs and assess opportunities to help drive future product and educational programs.
Program Director, WW Clinical Operations
Johnson & Johnson
Diamond Bar, CA
10.2009 - 03.2012
- Ongoing leadership activities from previous roles and:-
- Developed Clinical program from ground up, laying out framework and defining roles for the specialist Circular Ablation Incubator project within Biosense Webster for the US and EMEA. This project was established to fast-track Advanced R&D development projects to market
- Fostered excellence by example by "setting pace" and being hands on mentor to clinical staff. Orchestrated smooth and efficient program development by collaborating cross-functionally across departments.
- Met with project stakeholders on regular basis to assess progress and make adjustments.
- Provided ongoing direction and leadership for program operations.
- Core Team Member for New Catheter Technologies programs
- Support all Pre-clinical development of new technology platform
- Johnson & Johnson Front Line Leaders II
- Received Johnson and Johnson Standards of Leadership award
Manager Global Clinical Operations
Johnson And Johnson
Diamond Bar,, CA
10.2008 - 10.2009
- All tasks for Manager Clinical Operations and:-
- Manage the cross-functional Investigator-Initiated Study (IIS) review committee
- Responsible for the direction of the US Ventricular Tachycardia (VT) Condition of Approval clinical group and EMEA clinical organization
- Core Team Member for 2009 New Catheter Technologies programs
- Functioned productively in matrix organization across organizational levels and organized and prioritized responsibilities to meet commitments.
- Recruited, interviewed and hired 6 US based employees and implemented mentoring program to promote positive feedback and engagement.
- Hired trained and managed EMEA clinical team of 4 based in Belgium.
Manager Clinical Operations
Johnson & Johnson
Diamond Bar, CA
12.2006 - 10.2008
- All tasks for Clinical Project Manager and:-
- Support all landmark studies in Atrial Fibrillation (AF)
- Successfully surpassed enrollment target in the VT COA study with more than 12-14 subjects enrolled per month to accelerate expected study enrollment time line
- Directed annual investigator meetings
- Key member of both the AF and VT Physician Advisory Boards
- Core Team Member on developing catheter technologies for AF and VT
- Selected, promoted and terminated staff members.
- Promoted high morale and staff retention through dynamic communication, prompt problem resolution, proactive supervisory practices and facilitation of positive work environment.
- Reviewed financial resources and prepared reports showing resource allocations.
- Delivered effective training to new and existing employees and cross-trained staff members in other job roles to maximize coverage.
Clinical Project Manager
Johnson & Johnson
Diamond Bar, CA
06.2006 - 12.2006
- Communicated effectively with staff members, physicians and patients, employing active listening and interpersonal skills.
- Promoted high morale and staff retention through dynamic communication, prompt problem resolution, proactive supervisory practices and facilitation of positive work environment.
- Delegated tasks to staff members, monitored completion of all duties and provided support to enhance performance. Lead team of 3 in development of clinical VT protocols and supporting regulatory documentation
- Responsible for site selection, contract and grant and IRB negotiations for 18 sites involved in THERMOCOOL VT COA post approval study
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Maintained compliance with protocols covering patient care and clinical trial operations
- Worked with principal investigators and CRC to facilitate daily trial activities and comply with research protocols.
- Core team member of VT Strategic plan for future strategic company objectives
- Key Clinical liaison between Haifa, Israel Research Group and US clinical organization.
- Prepared a variety of different written communications, reports and documents to ensure smooth operations.
- Coordinated clinical trials focused on disorders such as Atrial Fibrillation and Ventricular Tachycardia and SVT's.
Previous Experience on Request
Hospitals And MedTech
United Kingdom And USA
Education
Bachelor of Science - Medical Physics And Physiological Measurement
Paddington College
London, United KingdomSkills
- International Clinical Research
- Project oversight and Trial Management
- Study Protocols
- Research SOPs Writing and Understanding
- Documentation Requirements and review
- Key stakeholder relationship building
- Teamwork and Collaboration
- Budgeting
- Vendor selection and management
- Written and verbal communication
- Flexible and Adaptable
- Conflict Resolution
- Training and mentoring
- Team Building
- Hiring and recruitment
- Developing education and training programs
Accomplishments
Johnson and Johnson Front Line Leaders I and II
Johnson and Johnson Standard of Leadership Award
Lean Sensei International: Lean Sensi Takumi Certification
Echelon Front: Extreme Ownership
Awarded EU Patent: Catheter with arcuate end section #:12185274.3 – 2305 for Johnson and Johnson Biosense Webster.
Disease State Knowledge
- Interventional Cardiology
- Interventional Electrophysiology (SVT's, Atrial Fibrillation and Ventricular Tachycardia's)
- STEMI cooling
- Heart Failure
- Cardiac Surgery
- Implantable Devices
- Real world Evidence study for Multiple Sclerosis
- Interventional Neurology (cSDH and AIS)
- Diabetes (CGM)
- Pressure Ulcers (early detection)
Bibliography
Hill, P. (2017). Guest Editorial and Personnel Perspective on Dr. Mark E. Josephson. Arrhythmia & Electrophysiology Review. Volume 6 Spring 2017
Papageorgiou P, Monahan K, Boyle NG, Seifert MJ, Beswick P, Zebede J, Epstein LM, Josephson ME. Site Dependent Intra-Atrial Conduction Delay. The Josephson School: A Legacy of Important Contributions to Electrophysiology. 2015 May 15;94:461.
Boyle NG, Anselme F, Monahan KM, Beswick P, Schuger CD, Zebede J, Josephson ME. Twiddler's syndrome variants in ICD patients. Pacing and Clinical Electrophysiology: PACE. 1998 Dec 1;21(12):2685-7.
Wellens HJ, Buxton AE, Marchlinski FE, Zimetbaum P, editors. The Josephson School: A Legacy of Important Contributions to Electrophysiology. Cardiotext Publishing; 2015 May 15.
Anselme F, Frederiks J, Papageorgiou P, Monahan KM, Epstein LM, Spach MS, Josephson ME. Nonuniform anisotropy is responsible for age-related slowing of atrioventricular nodal reentrant tachycardia. Journal of cardiovascular electrophysiology. 1996 Dec;7(12):1145-53.
Anselme F, Hook B, Monahan K, Frederiks J, Callans D, Zardini M, Epstein LM, Zebede J, Josephson ME. Heterogeneity of retrograde fast-pathway conduction pattern in patients with atrioventricular nodal reentry tachycardia: observations by use of simultaneous multisite catheter mapping of Koch's triangle. Circulation. 1996 Mar 1;93(5):960-8
Timeline
Senior Director
DNAnexus
04.2019 - 03.2020
Senior Director Clinical Affairs
ZOLL Circulation
08.2017 - 02.2019
Independent Consultant
Philippa Hill Consulting
02.2015 - Current
Director Clinical Affairs
Intersection Medical, Inc
01.2014 - 02.2015
Senior Clinical Program Manager
Medtronic, Hospital Critical Care
04.2012 - 01.2014
Program Director, WW Clinical Operations
Johnson & Johnson
10.2009 - 03.2012
Manager Global Clinical Operations
Johnson And Johnson
10.2008 - 10.2009
Manager Clinical Operations
Johnson & Johnson
12.2006 - 10.2008
Clinical Project Manager
Johnson & Johnson
06.2006 - 12.2006
Previous Experience on Request
Hospitals And MedTech
Bachelor of Science - Medical Physics And Physiological Measurement
Paddington College