Brooke Mccutchan, Mt (Ascp) Email & Phone Number

Carlsbad, California, Us

* Leads a team comprising 10 full-time employees and various independent contractors.* Acts as embedded executive leadership upon request, overseeing regulatory, clinical, and/or quality aspects of clients' business.* Plays a pivotal role in augmenting overall company revenue through effective business development initiatives.* Formulates Statements of Work (SOWs), establishes budgets, and supervises the contracting process.* Develops clinical and regulatory strategies for clients, contributing to their success.* Prepares comprehensive regulatory submissions for clients, encompassing Pre-EUA, EUA, Q-Submissions, De Novo, 510k, PMA, Technical Files for high and moderate complexity, and CLIA waived (POC and OTC) devices.* Represents clients on core teams, providing expertise in clinical and regulatory matters.* Engages with the FDA and other regulatory bodies, representing clients in regulatory affairs.* Aids in the creation and implementation of ISO 13485/21CFR compliant Quality Management Systems for clients.

Carlsbad, California, Us

* Named Partner February 2021

Carlsbad, California, Us

Austin, Tx, Us

* Led a team of ten, including three Clinical Study Managers and seven Clinical Research Associates, across two corporate sites.* Acted as the Clinical Affairs lead on various evaluation and core teams, taking charge of establishing clinical trial assumptions, schedules, and budgets for new products.* Formulated clinical trial study designs, ensuring harmony with FDA feedback on Pre-Submissions.* Delivered presentations to executives during monthly project review meetings.* Engaged in teleconferences with the FDA to review and secure approval of clinical trial strategies.

Northbrook, Il, Us

Held direct accountability to Executive Management for overseeing all Clinical and Regulatory Affairs activities. Formulated clinical and regulatory strategies, established budgets, timelines, and resource requirements for the department. Other notable accomplishments encompassed:* Oversaw and directed the activities of the Clinical Affairs team, consisting of five direct reports and a Contract Research Organization (CRO).* Initiated recruitment, hiring, and comprehensive training for the entire Clinical Affairs team from the ground up starting in April 2015; earned promotion to Director in April 2016.* Managed key responsibilities, including trial site qualification, initiation, and training, IRB approval, budget negotiation and contracting, development of clinical study and reference method protocols, ICH GCP-compliant trial management, data auditing, and drafting clinical sections of the 510(k).* Directed the development of protocols and execution of studies on both commercialized assays/instrumentation and those under development in the Clinical Affairs Laboratory.* Established a bio-repository for procuring clinical specimens to support development activities, analytical studies, and clinical validation studies.* Took on the role of Clinical/Regulatory lead on multiple project core teams for new product development.* Actively participated in teleconferences and face-to-face meetings with the FDA to review and secure approval of clinical and regulatory strategies.* Held the position of Acting Director of Regulatory Affairs from March 2015 until the promotion in April 2016.* Nanosphere was acquired by Luminex in June 2016.

Northbrook, Il, Us

Personally responsible for overseeing the implementation of various integrated cross-functional project plans, involving the development of schedules, milestones, budgets, risk assessments, and resource allocation to achieve corporate objectives. Notable achievements encompass:* Instituted a Program Management Office.* Orchestrated activities for the creation and submission of multiple 510(k)s, all leading to successful clearance.

Northbrook, Il, Us

* Developed and implemented both tactical and strategic marketing plans aimed at meeting annual sales targets.* Collaborated in the design and administration of a comprehensive training and proficiency program for new sales representatives.

San Diego, Ca, Us

Answerable to senior management for overseeing all program management facets related to the development of molecular diagnostic products. Additional responsibilities comprised:* Headed eight cross-functional molecular product development teams, guiding them from the initial concept through development, verification/validation testing, manufacturing design transfer, and eventual product launch on various instrument platforms.* Compiled and delivered status updates to the executive team during monthly project review meetings.

San Diego, Ca, Us

Accountable for overseeing timelines, budget, resources, and product development endeavors across three contracted design and development firms, focusing on a sophisticated fluorescence microscopy device, consumable, and novel multiplex assays. Additional duties encompassed:* Initiated, trained, and supervised international beta sites on-site in China and New Zealand.* Formulated and implemented training programs tailored for sales representatives, distributors, and end-users.* Developed Business Cases and Marketing Requirement Documents for new menu offerings.* Designed the graphic user interface and crafted User, Training, and Service Manuals for the system.* Diagnostic Hybrids underwent acquisition by Quidel in January 2010.

In charge of conducting thorough market research to establish product requirements for a mid-range platform interpreting direct fluorescent antibody preps, including instruments, software, reagents, and consumables. Additional accomplishments encompassed:* Oversight and management of a multi-site clinical trial for a rapid respiratory direct fluorescent antibody assay.* Efficient management of scope, schedule, and budget through collaboration with three contract design and development firms.

Bray, Co. Wicklow, Ie

Accountable for devising and implementing marketing plans to attain business plan objectives, with a focus on launching new coagulation assay and instrument products. Additional accomplishments include:* Elevated from Product Manager to Marketing Manager within 8 months.* Developed and implemented the inaugural New Hire Training Program for sales and marketing personnel.* Spearheaded the integration of the $16.5M bioMerieux coagulation product portfolio post-acquisition.

Leverkusen, North Rhine-Westphalia, De

* Earned the President's Club Award in 2003 by surpassing budget expectations with a remarkable 191% achievement.* Tasked with meeting annual sales targets in the Florida territory for the Advia 120 and 2120 hematology analyzers.* Accountable for accomplishing yearly sales objectives across a 13-state territory for the RapidPoint Coag point-of-care coagulation analyzer and associated reagents, securing placements in Cardiac Cath, CVOR, POL, and STAT Labs.

Responsible for providing telephone and on-site training as well as support to clinical laboratories, focusing on the coagulation assay and instrumentation product portfolio.

Sierra Laboratory Corporation, Charlotte, NC 1995-1996Anson County Hospital, Wadesboro, NC, 1994-1995

Bs, Medical Technology

Mt (Ascp)

Bs, Biological Sciences

Education record