Tag Archive for: Clinical Affairs

Jing Xie, PhD, MS, Joins MDIC as Vice President, Clinical Affairs

Former Vice President, Global Clinical Affairs, Zimmer Biomet

Life Science Partner recruited Jing Xie, PhD, MS, former Vice President, Global Clinical Affairs for Zimmer Biomet to become the Medical Device Innovation Consortium’s (MDIC) first Vice President, Clinical Affairs.

MDIC is the first-ever public-private partnership (PPP) created with the sole objective of advancing medical device regulatory science to expedite development, assessment, and review of innovative medical technologies. The overall mission of the MDIC is to support the FDA’s vision to achieve first in the world patient access in the US and to assure the safety and effectiveness of medical devices through the Total Product Life Cycle.

Xie takes on her new role at the MDIC after having oversight of approximatively 300 clinical projects worldwide for Zimmer Biomet. She possesses a highly successful track record in the orthopedic industry for delivering on objectives, while maintaining effective collaboration with internal and external stakeholders.

“With a global understanding around clinical trial management including data integration for regulatory agencies across the US, Europe and Asia, Xie is a well-seasoned leader to execute the clinical affairs initiatives at the MDIC,” states Tom Callaway, MD, Founder and President of Life Science Partner.

Jing Xie earned her Bachelor of Science Degree in Analytical Chemistry from Xiamen University in China and completed her PhD in Materials Science from the University of Alabama. She holds an MS in Computer Science from Purdue University and an MS in Chemistry from the University of Alabama.

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Barb DeBaun, RN, MSN Recruited to Vestagen as Consulting Vice President, Clinical Affairs

Improvement Advisor for Cynosure Health Joins Vestagen

Life Science Partner recruited Barb DeBaun, RN, MSN, CIC, to become Vice President, Clinical and Regulatory Affairs for Vestagen Technical Textiles, Inc.

DeBaun joins Vestagen after serving as an Improvement Advisor for Cynosure Health where she provided vision and leadership in the development, implementation and facilitation of performance improvement initiatives for healthcare organizations.

In her new role at Vestagen, DeBaun will serve as the senior clinical leader for The Company overseeing clinical direction, product strategy, medical affairs and key thought leader development. “DeBaun’s passion for protecting the healthcare worker from infection while providing quality care makes her a natural fit for Vestagen’s VP of Clinical and Regulatory Affairs,” states Tom Callaway, MD, Founder and President of Life Science Partner.

DeBaun earned her Bachelor of Science in Nursing from Pace University and her Master of Science in Nursing from San Francisco State University. DeBaun is an active member of APIC having served as the chair of the 2012 APIC Annual Conference Committee and as a member of the APIC Education Committee and the APIC Practice Guidance Council. In 2008, she was selected as Infection Control Today‘s Educator of the Year.

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Dan Merz Joins St. Jude Medical as Director, Clinical Affairs

ATLANTA, Georgia – March 14 2013

Life Science Partner announces the recruitment of Dan Merz to become Director, Clinical Affairs for St. Jude Medical. Merz is an innovative engineer who has created teams and processes to improve the speed of clinical development and product approval in the US and Japan.

Merz’s leadership capabilities will serve him well in his new role as Director, Clinical Affairs at St. Jude Medical, where he will have the responsibility for clinical trial monitoring, budget and clinical trial agreement process, as well as the responsibility for directly leading the teams accountable for the clinical program activities for the Portico TVH valve studies.

In his most recent role, Merz served as Director, Clinical and Regulatory Affairs for American Medical Systems (AMS) where he led the organizational redesign of AMS clinical research executive teams to align with Endo Pharmaceuticals. Since the realignment of the clinical organizations, Merz launched 292 patient randomized trials in Europe with 30 sites involving 11 nations.

“Merz is an articulate leader who has motivated teams to overcome regulatory hurdles and as to provide new tools for physicians to treat their patients,” noted Tom Callaway, MD, founder of Life Science Partner. “He has successfully built and led clinical organizations to move an innovative technology to the market.”

Merz earned his Bachelor of Science Degree in Biomedical Engineering at Northwestern University.

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Life Science Partner is a specialized executive search firm that recruits transformational leaders for healthcare and life sciences companies. Our high-touch, partner-led process ensures an exceptional level of service, while our backgrounds as physicians and industry executives enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

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Maria Koullick, PhD, joins AGA Medical as Senior Director of Clinical Affairs

Life Science Partner recruits former Clinical Affairs Executive at ATS Medical, Inc.

Life Science Partner announces the recruitment of Maria Koullick, PhD, a senior clinical trials executive, to AGA Medical to become Senior Director of Clinical Affairs for the company.

AGA Medical Corporation is a Plymouth, Minnesota based medical device company focused on the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.  AGA Medical was recently acquired by St. Jude Medical.

Koullick comes to AGA Medical from ATS Medical, a Minneapolis-based company which was recently acquired by Medtronic.  She directed the strategy and executed the company’s clinical programs for surgical valves, repair products and surgical ablation technologies.

Previously, Koullick held similar roles of increasing responsibility at Medtronic’s Cardiac Rhythm Disease Management and Neurological Divisions.

“Maria has a unique international clinical research trajectory – from the Cardiovascular Surgery Center in Moscow to the National Cardiovascular Surgery Center in Osaka to Medtronic,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “Her metric-driven skills emerge from her PhD in Biomedical Engineering, but she has also demonstrated her ability to build and lead a team that accomplishes difficult goals.

She will serve the company well in its mission to bring lasting improvements for patients with cardiovascular defects and peripheral vascular disease.”

Koullick earned her Bachelor and Master of Science degrees in Organic Chemistry from the University of Chemical Technology in Moscow, Russia.  She completed her PhD in Biomedical Engineering at the Bakulev Cardiovascular Surgery Center.

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Pam Simons joins AGA Medical as Senior Director of Clinical Affairs

Life Science Partner recruits former Vice President, Clinical and Regulatory Affairs at Uptake Medical

Life Science Partner announces the recruitment of Pam Simons, an experienced medical device clinical and regulatory executive, to AGA Medical to become Senior Director of Clinical Affairs for the company.

AGA Medical Corporation Plymouth, Minnesota based medical device company focused on the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.

In Simons’ previous role at Uptake Medical, a Seattle-based company developing non-surgical treatment for emphysema and COPD, she was responsible for worldwide efforts in clinical and regulatory affairs for the company.  Previously, Simons held a similar role at First Circle Medical where she led development and execution of the company’s global clinical development from Phase I to commercialization.

“Simons is a high energy individual with a demonstrated track record of success in development and execution of clinical strategy and regulatory approval for innovation Class II medical devices,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “With her passion and experience, she will serve AGA Medical well in its mission to bring lasting improvements for patients with cardiovascular defects and peripheral vascular disease.”

Simons earned her Bachelor of Science degree in Radiologic Sciences from the University of North Carolina at Chapel Hill.

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Jay Millerhagen joins St. Jude Medical Atrial Fibrillation Division as Senior Director, Clinical Affairs

Life Science Partner recruits former Senior Executive of Boston Scientific Cardiac Rhythm Management Division.

Life Science Partner announces the recruitment of medical device executive Jay Millerhagen to St. Jude Medical, a global cardiovascular medical device company, based in St. Paul, Minnesota.

St. Jude’s Atrial Fibrillation Business Unit designs, manufactures, and markets specialty cardiovascular devices for the electrophysiology segment of the cardiac rhythm management market and for the interventional cardiology market.

Millerhagen was most recently Director of Patient Management Business Alliance at Boston Scientific Cardiac Rhythm Management (CRM) where he managed business alliance strategies for key products and partnerships and clinical data initiatives for the division.  Prior to Millerhagen’s Business Alliance role, he directed Heart Failure Market Development for CRM.  There, he assembled and managed a large marketing team responsible for Guidant/Boston Scientific’s HF product line and led the development, recruitment and oversight of the COMPANION trial.

“Millerhagen has moved from early stage product development to clinical development to successful product launch in the CRM arena” noted Tom Callaway, MD, founder and president of Life Science Partner.  “As a highly strategic ‘best athlete’ in the CRM Business, he will bring experienced clinical development leadership and quality execution to the St. Jude’s Atrial Fibrillation Division.

Millerhagen earned a Bachelor of Arts in Physiology and Psychology from Concordia College in Moorhead, Minnesota and a Master of Science in Exercise Physiology from St. Cloud State University.  He received an MBA in General Management from the University of St. Thomas in St. Paul, Minnesota.

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Jane Weiss Doerr joins Windy Hill Medical as Director of Clinical Affairs

Life Science Partner recruits former Senior Director, Program Management for Genzyme Corporation

Life Science Partner announces the recruitment of Jane Weiss Doerr, RN, MSN, a seasoned oncology clinical trials executive, to Windy Hill Medical as Director of Clinical Affairs.

Windy Hill Medical is a California-based medical device and pharmaceutical company focused on the development of products to reduce the risk of developing breast cancer in patients deemed to be at high risk.

In Doerr’s previous role at Genzyme, a global biotechnology company developing advanced technologies for the treatment of numerous debilitating diseases, she managed a multi-disciplinary global product development team delivering oncology products to the market.  Previously, Doerr was Director and Product Team leader for ILEX Oncology, Inc. where she was responsible for numerous oncology products in various stages of development.  She also served as Senior Vice President for Oncology Research Partners, a national network of academic and community physicians focused on cancer care.

“Jane has a wealth of experience in the oncology clinical and biopharmaceutical industry and is well-grounded as a strategic thinker and operational leader,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “She is very passionate about bringing lasting improvements in healthcare for patients with cancer.”

In her role as Director of Clinical Affairs, Doerr will have the responsibility for managing all phases of Windy Hill’s global clinical trials for the expanding portfolio of compounds under development.  She will collaborate with academic thought leaders, provide strategic direction to the company and build a world-class clinical development team with an eye toward successful FDA and European approvals.

Doerr earned her Bachelor of Science in Nursing at the University of Texas Health Science Center School of Nursing in San Antonio, Texas.  She received a Master of Science in Nursing from the University’s Graduate School of Biomedical Sciences.

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