Clinical Trial Manager, Clinical Trial Coordinator, Clin Trial Liaison

SUMMARY OF EXPERIENCE

Senior operations leader with expertise in all phases of global drug development, clinical trial conduct, site/vendor management, maintenance of timelines/budgets, inspection readiness, GCP auditing and consulting.

THERAPEUTIC EXPERTISE

Gene Therapy

Infectious Disease

Neurodegenerative Disease

Asthma

Rare Disease

Renal Disease

Transplantation/Immunology

CV Disease

INDEPENDENT CONSULTING:

Civitas Therapeutics, Inc., Chelsea, MA

February 2013 – July 2015

Alnylam Pharmaceuticals, Inc., Cambridge MA

July 2013 – July 2015

Clementia Pharmaceuticals, Inc., Dorval, Quebec, Canada

July 2015 – July 2016

Allena Pharmaceuticals, Newton Lower Falls, MA

July 2015 – October 2016

Infinity / Verastem Pharmaceuticals, Needham, MA

November 2016 – March 2017

Voyager Therapeutics, Inc., Cambridge, MA

April 2017 – July 2019

Asceneuron SA, Lausanne, Switzerland

July 2019 – October 2020

Talaris Therapeutics, Inc., Wellesley, MA

November 2020 –May 2021

Asceneuron SA, Lausanne, Switzerland

May 2021– September 2021

Pulmatrix, Inc., Lexington, MA

January 2022–April 2022

AVROBIO, Inc., Cambridge, MA

April 2022–October 2022

Vendor compliance audit (confidential), San Diego, CA

December2022–February2023

Verge Genomics, South San Francisco, CA

September2023–May 2024

Develop RFPs (Requests for Proposals) for Phase I - III Clinical Programs.

Analyze RFP proposals/organize Bid Defense meetings.

Develop clinical budgets for Phase I – III clinical programs.

Solicit/select/negotiate/manage vendor contracts for Phase I – III clinical programs.

Manage study start-up activities, timelines/deliverables, close out with final reconciliation.

Review/edit study documentation provided by CRO and clinical sites with respect to protocol adherence and GCP compliance.

Review/edit study manuals/plans for content and user friendliness (Manual of Operations, Monitoring Plan, Project Management Plan, Communication Plan, etc.)

Create study specific documents in accordance with protocol specifications.

Review eCRFs (i.e., Medidata Rave), DVSs and perform UAT as required.

Conduct clinical site audits, pre-inspection audits, provide site and CRO training as required.

Manage global ISL distribution processes in collaboration with PVG vendor.

c Watertown, MA February 2012 – October 2012

Director Early Phase Clinical Operations

Initiated/managed first-in-man phase I SAD, MAD, FE study (PRA, the Netherlands) for the PDE10 Program.

Managed vendor (CRO) selection; directly managed RFP processes for phase I studies, including renal, hepatic, abuse liability, alcohol interaction, phase II Negative symptoms in Schizophrenia and for a phase III AD Clinical Program.

Coordinated protocol development/negotiated study budget for phase I study (CSF amyloid concentrations) in healthy volunteers and in subjects with MCI/AD for the GSM Program.

FoldRx Pharmaceuticals, Inc., Cambridge, MA May 2005 – November 2011

(Acquired by Pfizer, Inc., October 2010)

Senior Director Clinical Operations

Coordinated Clinical Operations Team submission of the marketing authorization for tafamidis through the centralized process in the EU; MAA application approved 2011.

Conducted audits/training for pivotal trial sites to ensure inspection readiness and adherence to US and international regulations and GCP requirements.

Managed due diligence audits resulting in acquisition by Pfizer.

Managed and completed 9 phase I, and 4 phase II-III clinical trials (rare disease) in 10 countries (NA, SA, and EU).

Directed CRO/vendor selection and management, budget/contract negotiation, investigator and site staff training.

Developed clinical protocols/amendments, informed consent forms, case report forms, source documents and clinical study reports.

Developed standard operating procedures and established trial master files in accordance with GCP requirements.

ActivBiotics, Incorporated, Lexington, MA 2002 – 2005

Director Clinical Operations

Reactivated in-licensed IND; planned IND applications for new antibiotic formulations.

Directed 5 phase I and 2 phase II trials to support the primary indications.

Negotiated contracts with vendors, including CROs, animal research facilities, central labs, EDC concerns, and regulatory/statistical consultants.

Prepared, negotiated and managed phase I/II clinical trial budgets.

Beth Israel Deaconess Medical Center, Boston, MA

Administrative Director, Office of Clinical Trials and Research (OCTR) 1997 – 2001

Established and directed unique centralized office providing customized clinical trial support services to clinical investigators and industry sponsors. Principal therapeutic areas included cardiology, neurology, infectious disease and hematology/oncology. OCTR facilitated research collaboration with Harvard Medical School, Partners (MGH and BWH) and the Dana Farber Cancer Institute. OCTR services included contracting and budgeting, regulatory submissions, safety reporting, fiscal management, patient recruitment/retention, training and education, and marketing. OCTR successfully managed 250 trials generating $7 million annually.

Project Director, Harvard Clinical Research Institute (HCRI) 1995– 1997

Directed large-scale, multi-center, national/international, phase II/III clinical trials. Responsibilities included the development of investigational plans, case report forms, and manuals of operation. Led project team, established priorities and timelines, and served as the liaison to corporate clients. Conducted nation-wide investigator meetings and monitor training sessions for corporate sponsors.

Clinical Research Nurse/Clinical Staff Nurse 1982–1994

Coordinated clinical trials for the Department of Anesthesia and Critical Care, for the Thrombosis and Hemostasis Research Laboratory and for the Department of Infectious Diseases. Clinical staff nurse in the Surgical Intensive Care Unit (SICU) and in the OR.

EDUCATION

Bachelor of Science in Nursing; BA Psychology

Northeastern University, Boston, MA, 1979

CONTINUING EDUCATION

Boston University, Graduate School of Nursing, 1980 – 1981

Simmons College, Graduate Division (Biostatistics and Epidemiology), 1986

UMASS Boston, Graduate Division (Business Management), 1999

PROFESSIONAL LICENSURE

Commonwealth of Massachusetts Registration #138471

Salzman EW, Weinstein MJ, Weintraub RM, Ware JA, Thurer RL, Robertson L, Donovan A, Gaffney T, Bertele V, Troll J, Smith M, Chute LE. Reduction in Blood Loss after Cardiac Surgery by Vasopressin (DDAVP): A Double-Blind Study. NEJM 1986; 314 (22):1402.

Salzman E, McManama G, Shapiro A, Robertson L, Donovan A, Blume H, Sweeney J, Kamm R, Johnson M, Black P. Hemodynamics on Fibrinolytic Activity and Antithrombotic Efficacy with External Pneumatic Cuff Compression. Ann Surg. 1987; 206 (5):636.

Gerhart T, Yett H, Robertson L, Lee M, Smith M, Salzman EW. Heparinoid Organon 10172 vs. Warfarin to Prevent Thrombosis After Hip Fracture. Thrombosis & Haemostasis 1989; 62:1534.

Gerhart T, Yett H, Robertson L, Lee M, Smith M, Salzman E. Low-Molecular-Weight Heparinoid Compared with Warfarin for Prophylaxis of Deep Vein Thrombosis in Patients Who Are Operated on for Fracture of the Hip. J Bone and Joint Surg. 1991; 73A (4):484.

Shorten GD, Seiber T, Maslow AD, Haering JM, Robertson LK, Comunale ME. Left Ventricular regional wall motion and haemodynamic changes following pipecuronium or pancuronium to adult patients undergoing CABG. Canadian J. Anesthesia, 1995; 42 (8):1-6.

Comunale ME, Carr JM, Moorman RM, Robertson LK. Significance of D-dimer Concentrations during Cardiopulmonary Bypass. J Cardiothoracic & Vascular Anesthesia. 1996; 10 (4):477-481.

Comunale ME, Haering JM, Robertson LK, Lowenstein E. Aspirin prevents protamine induced pulmonary hypertension. IARS. 1997.

Baim DS, Cutlip DE, Midei M, Linnemeier TJ, Schreiber T, Cox D, Keirakes D, Popma JJ, Robertson L, Prince R, Lansky AJ, Kalon KK, Kuntz RE. Final results of a randomized trial comparing the MULTI-LINK stent with the Palmaz-Schatz stent for narrowings in native coronary arteries. Am J Cardiol. 2001 Jan 15;87(2):157-62.

POSTER PRESENTATIONS: Canney K, Robertson L, Comunale ME. Late Heart Time Study: Improving OR Efficiency for Cardiac Surgery. Health Care Quality Improvement Conference: Generating Multidisciplinary Interchange. Woburn, MA, September, 1993.

Haering JM, Comunale ME, Maslow A, Robertson L. On-Line Measurement of Aortic Valve Area Using Multiplane Transesophageal Echocardiography in Patients Undergoing Aortic Vascular Surgery. Poster presentation at the 16th Annual Meeting of the Society of Cardiovascular Anesthesia, Montreal, Quebec, April, 1994.

Shorten GB, Comunale ME, Cohen M, Robertson L, Darvish A. Perioperative Arrhythmias in Patients Undergoing Major Vascular Surgery. Poster presentation at the 68th Clinical and Scientific Congress, IARS, March, 1994.

Shorten GD, Comunale ME, Maslow A, Haering JM, Robertson L. Myocardial and Hemodynamic Effects of Pipecuronium or Pancuronium 68th Clinical & Scientific Congress, IARS, March, 1994.

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