Denise Wills, BS, MBA

856-***-****

ad3qcx@r.postjobfree.com

CAREER SUMMARY – Seasoned industry professional with proven successful track record in medicines development in all phases across several therapeutic areas. Very experienced in both the client and CRO sides of the industry. Strengths include communication, strong leadership, strategic, analytical, flexible, organizational, planning, and visionary. I’ve held various roles as indicated below as permanent employee and consultant:

Clinical operations – Sr. CRA, Sr. Clinical Trial Manager, Sr. Study Manager, Global Trials Leader

Project management – Sr. Clinical Project Manager, Global Project Manager, Project Director, Global Project Director, Sr. Project Delivery Lead

Clinical development – Sr. Clinical Scientist, Lead Clinical Scientist

Phases – Phase 1 (domestic & global), Phase 2 (domestic & global), Phase 3 (domestic & global), Phase 4, FIH, ITT/ISTs, INDs, I-INDs.

Therapeutic Areas – oncology, cardiovascular, infectious disease, ophthalmology, CNS, rare diseases, neurology, general medicine, gastroenterology.

Additional Skills sets – quality assurance (GCP/GLP expert, site & eTMF (VEEVA) audits, inspection prep, QEs, CAPAs), compliance, medical writing (protocols, IBs, annual reports), plans development, risk assessments, data review, eCRF design & development, ICF template development, biomarkers (selection, tracking), vendor management, timeline development & tracking, contracts & budgets, training, process development.

Industries – large, medium, and small pharma, biotechnology, medical device

Key Accomplishments – completed clinical trials ahead of timelines and within budget, lead successful health authority inspections addressing and mitigating findings, lead diverse project team in successful NDA and BLA filings.

EXPERIENCE

Agios Pharmaceuticals, Consultant

Sr. Clinical Trial (Project) Manager, Nov 2022 to July 2023

Responsible for overall operational execution and oversight for (4) phase 2 global rare disease studies for PKD, Sickle cell anemia, and thalassemia. Managed the day-to-day operations of the CRO and external vendors to ensure on-time and quality deliverables per the project plan; developed study specific risk profiles and continually assessed for audit readiness, lead the multi-disciplinary CTWG meetings, review/assessment protocol deviations and risks mitigation meetings, managed key operational and data management metrics tracking, monthly presentations of study status and key risk evaluations during departmental SOHR meetings. Responsible for developing and managing updates to master ICF templates and reviewed/approved customized local and institutional ICFs as per the SOPs and GCPs, worked closely with QA and developed actionable plans to address quality events and CAPAs; managed study timelines, study plans, team training, eTMF file reviews, study budget management, invoice review and payment approvals, and biweekly study status dashboard updates, and lead for the pre-inspection prep workstream for a MHRA audit.

Arcus Bio Therapeutics, Consultant

Sr. CPM, March 2022 to September 2022

Responsible for strategic project management and CRO oversight of a large phase 2, 7- cohort study investigating various combination treatments for advanced GI malignancies in start-up mode. Developed master ICF template, managed revisions and tracked change control. Reviewed and approved country and institutional ICFs in compliance with the master template, SOPs and GCPs and ICH guidelines. Co-developed, and approved study budget templates and contracts, study plans development, managed and approved vendor SOWs and budgets, and monthly reviews of overall study budget. Created risk profile with contingency plans and mitigation steps and incorporated the RACI model. Also serves as the SMTL for the internal functional team as well as overall management and oversight of the CRO and vendors; monthly study status presentations to department, dashboard updates; responsibilities also include metrics, timelines and milestone tracking, eTMF file audits, and monthly evaluations of risk management with the project team including quality assurance.

PPD, Project Delivery, Sr. Consultant

Sr. Clinical Project Lead, June 2021 to March 2022

Serve as the lead project manager for an oncology phase 1, first in human, CD39 RO drug to determine MTD for RP2D and dose expansion in solid tumors in pancreatic, lung, and gastric cancers across 15 sites in the United States from start-up activities including feasibility, final protocol, FDA follow-up, study and site contracts and budgets, master ICF development and approval, oversight of site ICF customizations, CRA training, developed SIV meeting decks, timelines and risk development profile and management, clinical supplies initial set-up thru the maintenance phase, lead for the cross-functional project team, Safety Management Team (SMT) and charter development. Also managed a phase 2 global study for thyroid cancer: global phase 1b/2 study for EGFR expression in advanced solid tumors. Responsibilities include leading multi-disciplinary teams, managing study budget accruals, revenue recognition, and scope creep. Responsible for timeline management, monthly presentation of studies to management (PAMs); ensuring the appropriate study plans are developed and maintained, data integrity, SOP/GCP/ICH compliance, quality events management, collaborated with QA on workstreams and governance initiatives, site communication during major milestones, eTMF file reviews and audits.

Blue Bird Bio, Consultant

Project Manager, Quality Assurance R&D, October 2020 to April 2021

Served as the QA GCP PM for pre-inspections and BLA filings. My responsibilities include driving the planning, preparation, tasks development and process development in collaboration with GxP groups in GCP, GLP, GVP, GMP, IT, DM, and supporting functions in preparation to file 4 BLAs by 4Q2021. Provide support, expertise, and direction to address mock and agency inspection findings/observations, tracking the development and finalization of SOPs, key initiatives, managed change control, storyboards development, CAPAs, risk management and mitigation plans, agency response strategies, and metrics monitoring to strongly position the company for successful regulatory audits by the EMA and FDA for successful BLA filings in CDER and CBER for rare and oncologic diseases. Manage timelines, forecasts, and milestones; schedule and lead meetings with the cross functional SMEs; facilitate dry runs for audit prep, brainstorming, risk assessment, gap assessments, and continued mock sessions; Prepare meeting agendas and minutes.

Janssen Pharma, Consultant on Assignment

Senior Clinical Trial Manager, Oncology, Oct 2019 to June 2020

My responsibilities included global coordination of clinical trial management activities for internally managed and/or outsourced trials. Responsibilities also include management of global vendors involved in site facing activities such as IVRS, central labs, ePRO, imaging, translation, printing, Ancillary supplies and meeting planners. Responsibilities also include leading the Study Management Team (SMT) leader a team of internal and external stakeholders (DM, regulatory, CMC/clinical supplies, biostats, clinical, CRAs, PhV/safety, biomarker, vendors) to the Global Clinical Development Operations (GCDO). In the Sr. CTM function, responsibilities also include CRA training, oversight of site budgets, eTMF audits; lead a global team on a phase 1b study with 11 cohorts for Acute Myeloid Lymphoma using an anti-CD70 antibody; study placed on indefinite hold due to COVID 19 pandemic.

Daichii-Sankyo, Inc., Consultant

Senior Delivery Lead (DL), March 2018 to Oct 2019

Oversight of the operational activities of a CRO to ensure integrity and strategic direction for a global 3-Part, dose escalation/dose expansion phase 1b combination study to treat subjects with HER2 expressing and/or HER2 low mBreast, mGastric cancers + cohorts of solid tumor cancers in various therapeutic indications using for 3 classes of drugs: Anti-body Drug Conjugate (ADC), Immuno-oncology (I-O), Ataxia Telangiectsia & Rad3 (ATR) Protein inhibitors among 8 countries across 38 sites. In addition, mangaged a large global phase III clinical trial for mBreast Cancer to recruit 630 subjects with HER2 Low expression across 225 sites in 18 countries in preparation of filing of a sBLA for an antibody conjugate; conducted feasibility studies, managed the protocol finalization, approved the master ICF template and site customizations, global regulatory start-up activities, developed eTMF structure and plan, facilitated finalization of all study plans, CMC/IMPD activities, and strategic execution of all study tasks/deliverables along the critical path to achieve study endpoint. Management and oversight of vendors services to include central and biomarker laboratories, central imaging, and IRT. Lead the project team consisting of all core functional groups and collaborated with the program lead in strategic direction and timeline development to the BLA; responsibilities also included management of study contracts/budgets, risk-based monitoring, data analytics, and quality tolerance limits (QTLs); utilization of tracking systems to evaluate and monitor study; preparation of weekly study status updates and executive summaries for senior management; Achieved protocol outline to First Subject Dosed (FSD) in 8 months.

Merck, Inc, Consultant

Lead Senior Clinical Scientist, Global Trial Clinical Operations, January 2016 to February 2018

Based in the Immuno-Oncology (I-O) GU unit; focus on a phase 2 mCastrate resistant prostate cancer (mCRPC) study for an unmet medical need. Lead all start-up activities and worked closely with the Senior Clinical Director (CD) to manage the clinical and scientific aspects of the study and in collaboration including protocol development and amendments, master informed consent development and revisions, medical monitoring, data review, developed and tracked data snapshots, and assisted biostats with data gathering and analysis, vendor management of contracts & budgets, clinical supplies/CMC planning and oversight, and achievement of study endpoint on time and on budget. Collaborated with the Senior Study Manager (SM) on strategic operations across 121 sites in 22 countries.

Key responsibilities include collaboration with the CD to successfully expand the study, chaired the Medical Monitoring Team (MTT) In-Life meetings, review and analysis of clinical data and worked in collaboration with the BARDS group on interim analyses, lead for deep dive meetings with the Sr. VP, preparation of sNDA filing.

BMS, Consultant

Senior Clinical Scientist Consultant, Global Clinical Operation, November 2015 to January 2016

Based in the clinical pharmacology group; oversight and management of SAD/MAD protocols in immuno-oncology (I-O) and immuno-science. Responsibilities include protocol development – study outline through finalization and publishing in (CARA3), clinical data reviewer, provide senior oversight to support therapeutic portfolios assets, development of all study plans – communication, monitoring, data review, project oversight of clinical managers.

Premier Research, Full time

Senior Global Project Manager, Project Management, March 2015 to October 2015

Responsible for management of operations and study milestones; served as project leader to facilitate achievement of milestones; managed clinical studies in oncology and analgesics/pain management. Management of 4 protocols in oncology and analgesics in Phase II and Phase III, managed adherence to project budget and scope of work and delivery of milestones, develops and manages study timelines using MS Project, tracking of project metrics in iTrack (CTMS) reporting through Dashboard and SharePoint.

BMS, Sr. Consultant

Senior Clinical Scientist/ Protocol Manager for a large pharma, ECTR, June 2014 to March 2015

Based in the exploratory translational group as a lead in operations of complex adaptive design studies in oncology and rheumatoid arthritis. Responsibilities include protocol development – publishing in (CARA3), IND submission for First In Human (FIH) study, All study start-up activities.

Quintiles, Inc., Sr. Consultant

Senior Clinical Project Manager for a large CRO, Oncology TDU, May 2012 to Dec 2013

Oversight and coordination efforts of cross- functional project teams to support milestone achievement from start-up through study endpoint including risk mitigation. Primary contact with Sponsor to ensure continuous flow of communication, manage, mentor, and train the CRA team, develop and manage project budgets, contracts, and financial responsibility with business development, managed and monitored Clinical Pharmacology (Phase I) studies in breast and ovarian cancer, solid tumors and lymphomas.

i3/PharmaNet, Full time

Global Trial Manager, Sept 2011 to May 2012

Responsible for planning, development, kick-off and start-up, and delivery of global phase 3 trials for rheumatoid arthritis. Manage the study timelines; Ensure the Computer Trial Management System (CTMS) is accurate and track project milestone dates to define metric; Management of CRA project activities.

Ono Pharma, Sr. Consultant

Senior Clinical Consultant, April 2011 to August 2011

In the clinical operations group, provided expertise and managed a multi-center phase I supportive care oncology study for CIT. Responsibilities included oversight of the CROs; managed the start-up activities in the US and Russia that included regulatory document collection, review of site contracts and budgets, selection of Russian CRO, proposal development, budget review, and strategy development for MoH submission; Site selection and conduct of SIVs in the USA.

Daiichi-Sankyo, Sr. Consultant

Senior Clinical Consultant, January 2011 to April 2013

Short term MAT assignment to provide oversight of CRO in managing the European start-up arm of a large global phase III study in non-small cell lung cancer (NSCLC) including regulatory submissions in Western and Eastern Europe; oversight of a CRO and study start-up of a phase II study for metastatic breast cancer (MBC) in Latin America. Developed informed consents risk sections for a phase 1b/phase 2 study; facilitated customizations per Argentinean IEC and MoH regulations; Provided direction and assisted in the strategy of the regulatory submission process ahead of projected timelines; Oversight of a CRO in the close-out activities of a first in human (FIH) study targeted for NSCLC.

Extraordinaire Consultancy, Inc. Senior Principal Consultant (from 2003 to 2009)

(1)ACORN CRO - March – June 2003 - Electronic Data Capture (EDC) on-site review of study data and source verification for a retrospective non-interventional oncology anemia trial.

(2)Aeterna Laboratories – June 2003 - August 2003 – At the request of the client, developed of a strategic plan and risk analysis for a pivotal global phase III trial in renal cell carcinoma.

(3)Hesperion Europe - September 2003 to November 2003 - Provided expertise and strategic input for a cardiovascular drug with orphan status in phase II study start-up mode.

(4)Kelly Scientific - October 2003 to November 2003 – developed a business proposal development for an RFP in data management services.

(5)Astra-Zeneca - November 2003 to August 2005 – managed all operational aspects of 4 studies in cardiovascular (platelet) from start-up to CSR, on-site monitoring of data and source verification, adherence to protocol, regulatory compliance, and clinical supplies for several phase I studies in cardiology; wrote CSRs.

(6)BMS - August 2005 to April 2006– Quality Assurance & Compliance, Global Medical Affairs working with Canada, Taiwan, and China to develop SOPs to comply with a defer prosecution agreement with the state of Massachusetts.

(7)Pharmanet - April 2006 –October 2006 – Management of a global phase III study in NSCLC; managed a team of CRAs & 2 PMs in the USA and 8 CRAs in Eastern Europe; Conducted on-site monitoring of EDC study data and source verification, site management; review of regulatory binders, assessed regulatory compliance to GCPs/ICH; managed all vendors and clinical supplies.

(8)Johnson & Johnson (Janssen) - October 2006 to October 2008 – functioned as a global trial leader managing a number of studies in the division of Global Clinical Operations (GCO); oversight of CROs, managed oncology trials across continents for a phase III multiple myeloma study; (3) non-interventional studies; management & training of local country managers & CRA team; assisted in the filing of a sNDA; clinical lead for FDA audits in the US & Eastern Europe; managed a large global EAP study in soft tissue sarcoma to include the CRO and vendors; set-up a new process for IST & IIT trials; Clinical supplies management (IVRS); CTMS; responsible for managing study budgets, financials, and milestones.

(9)Forest Laboratories - February 2009 to June 2009 – Development of a corporate initiative to accelerate study start-up activities and timelines. Created new processes and methodology for site activation.

Covance Inc., Full time

Global Project Director, May 2001 to Mar 2003

Responsible for clinical operations and program management for client portfolios in global clinical trials in oncology in Phase II (multiple myeloma) and Phase III (renal cell carcinoma) including vendor management and clinical supply management (IVRS); managed a team of CRAs and CTAs; lead large diverse global project teams; as a leader of my business unit, managed all aspects of client business including proposal development, client presentations, contract and budget management, delivery of milestones; process improvement, business development including participation in sales presentations.

Project Director, Feb 2000 to May 2001

Responsible for the management and delivery of client portfolios of clinical studies; managed all operational and project management activities for 5 oncology phase I trials in solid tumors; ISS and ISTs; Managed and trained CRAs and CTAs; conducted on-site review & source verification of study data to ensure accuracy and quality, regulatory binder review, assessed compliance with GCPs/ICH, site management, managed to ensure proper training of CRAs, clinical medical writer for IB updates; PM for a large global phase III Sepsis trial to final database lock; Lead global project teams; assisted medical writing in preparing sections of CSRs; primary client contact; maintained all project budgets.

Hesperion USA, Sr. Consultant

September 1999 to Feb 2000

Functioned as the operational lead in the US region for 3 large worldwide phase II/III clinical studies in cardiac transplantation for a small pharmaceutical company. Provided expertise in clinical operations and strategic project management; managed and trained regional CRAs; served as the liaison for US & Europe

Premier Research Worldwide, Full time

Clinical Project Manager July 1997 to September 1999

Responsible for clinical operations and project management for 9 phase II and III studies in contrast imaging for coronary artery disease, ventricular fibrillation, cardiac device trials for chronic atrial fibrillation for a large device company; Managed a large team of PMs, CRAs, and CTAs; developed and managed proposals and contracts, budgets, timelines, and project plans; lead project teams; clinical training; also functioned as a Senior CRA performing on-site visits that included review & source verification of study data, regulatory compliance, and site management.

Covance Inc., Full time

Project Manager Dec 1995 to July 1997

Responsible for clinical operations for a global phase III trial in contrast imaging for liver cancer, and a phase II trial in bladder cancer; Senior CRA for a compassionate use study for prostate cancer, a retrospective non-interventional study for low grade non-Hodgkin’s lymphoma (NHL), and phase IV trial for fungal disease. Responsibilities included CRF design, site management, regulatory binder review and maintenance, on-site review of data, source verification, and data collection (paper); Lead multi-disciplinary project teams with oversight of CSRs; a member of the core NDA team; managed a team of direct reports for CRAs and CTAs.

Otsuka America Pharmaceutical, Full time

Manager of Medical Affairs Department, January 1994 to December 1995

Responsible for development of the phase IV clinical trials department including budgets, forecasting; resource management, outsourcing to vendors; interacted closely with the marketing and sales groups to organize market developmental strategy meetings with industry thought leaders for new marketing ideas; Responsible for on-site monitoring of data and delivery of ophthalmic clinical trials conducted in phase IV for hypertensive glaucoma.

Senior CRA/Group Leader, Infectious Disease Group, Dec 1992

Responsibilities included training and development of 11 CRAs in the infectious disease group; preparation and development of Standard Operating Procedures (SOP) and clinical guidelines for monitoring, outsourcing lead for departmental projects, contract development and management, and CRO oversight; implementation, and execution for Phase II-III trials in chronic bronchitis, community acquired pneumonia, chronic obstructive pulmonary disease (COPD), sexually transmitted disease (STD), and dermatology; protocol development for chronic bronchitis, community acquired pneumonia, and chronic obstructive pulmonary disease (COPD), and skin infections for diabetic patients.

Senior CRA, Cardiovascular Group, May 1992

Responsible for protocol and case report form development for phase III study for All Cause Mortality in congested heart failure patients. Created monitoring tools for the study for the team; monitored 15 sites across the USA; developed and negotiated site budgets and CTAs; worked with QA to develop site audit plans; served on the SOP committee.

Boots Pharmaceutical, PLC, Full time

Clinical Research Associate, July 1990 to May 1992

Responsible for monitoring phase I, II, III, non-interventional, and compassionate use clinical trials in cardiovascular disease (congested heart failure, hypertension, and cardiac hemodynamics) and central nervous science (depression: chronic and seasonal) throughout the USA and Canada; design and development of case report forms; protocol review and development; SOP development; served on the NDA team for CHF; chairman of a large phase III All Cause Mortality trial for Congested Heart Failure; managed outsourcing to CROs.

G.D. Searle Worldwide Pharmaceutical R & D, Full time

Research Analytical Chemist, April 1984 to July 1990

Performed biochemical analysis of pre-clinical and clinical biological matrix samples to assess pharmacological (PK) interactions in new chemical entities (NCE) to determine accumulation, metabolism, and excretion profiles and 1st pass metabolism; analysis of ethical drugs and consumer products; protocol and assay development; data analysis and report generation; participation in FDA GLP and GMP audits. Principal author for five analytical methods from research to production mode; served as Chairman of the Safety Committee.

EDUCATION

Master’s in business administration (MBA) Johns Hopkins University, Baltimore, MD, 1996

Bachelor of Science in Chemistry, Lawrence University, Appleton, WI, 1983

Dale Carnegie management Course, 2003

DIA Center of Career Development, Medical Writing Clinical Study Reports, 2006

Publications/Presentations

Sweeney, M., Schniepp, S., Wills, D., “Chromogenic LAL as A Useful Assay for the Validation of a Water for Injection System”, LAL Quarterly Review, Fall 1985

Wills, Denise, “The Planning Paradigm: The Marriage Between Clinical Operations and Project Management, Drug Information Journal (DIA), volume 35, issue 35, 2001

Wills, Denise, “Practical Tools and Techniques for Project Planning and Control in Clinical Research”, Adis International, New Zealand, 2004

“Planning and Execution of An Effective Project Plan”, Speaker at the 2002 Annual DIA Convention, Chicago, ILL

“Developing The Project Plan”, Committee Chair and Speaker, 2005 Annual Euro DIA Convention, Paris,

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