Tag Archive for: Senior Director

Thomas Nikolai to Join Hospira as Senior Director, External Biologics Collaborations and Partnerships

Life Science Partner recruits former Director, Biologics, Parenteral Products at Abbott Laboratories

Life Science Partner announces the recruitment of Thomas Nikolai, MS, MBA, to become Senior Director, External Biologics Collaborations and Partnerships for Hospira’s biosimilars division.

Hospira is a global specialty pharmaceutical and medication delivery company that develops, manufactures and markets products that help improve the safety, effectiveness and costs of patient care.

Nikolai leaves Abbott with over 20 years of leadership experience in biologics process development, technical operations and manufacturing support.  In his most recent role, Nikolai served as Director, Biologics, Parenteral Products, where he was the Global CMC leader for commercial and late-stage biologic drug products including Humira, Abbott’s blockbuster arthritis drug.

“Nikolai is a passionate and results-driven professional with a progressive technical management career in the biopharmaceutical industry.” noted Tom Callaway, MD, Founder and President of Life Science Partner.  “He brings a wealth of knowledge and leadership to the biologics team at Hospira and will serve the company well as it provides biosimilar versions of the world’s most critical biological drugs.”

Nikolai received his Bachelor of Science Degree in Chemical Engineering and Bioengineering from the University of Wisconsin, Madison and his Masters of Science in Biochemical Engineering from the University of Minnesota, Twin Cities.  He earned a Masters in Business Administration from the University of Wisconsin, Parkside.

Learn More About Chief Medical or Regulatory Leaders
/0 Comments/by

Neil Schauer, PhD joins Hospira as Senior Director, Biologics Process Development

Life Science Partner recruits former Director of DSP Research and Development at Millipore Corp

Life Science Partner announces the recruitment of Neil Schauer, PhD, a seasoned biopharmaceutical development leader and scientist, to become Senior Director, Biologics Development for Hospira’s biosimilars division.

Hospira is a global specialty pharmaceutical and medication delivery company that develops, manufactures and markets products that help improve the safety, effectiveness and costs of patient care.

In his most recent role at Millipore Corp, Schauer was responsible for scientific and managerial leadership of a large research and development organization with four functional areas focusing on DSP Research.  Prior to his tenure at Millipore Corp, Schauer served as the Director of Cambridge Manufacturing Sciences at Biogen Idec.  In his new role at Hospira, he will have overall responsibility for providing strategic and technical leadership to a large staff of pharmaceutical scientists responsible for the development of Drug Substance and Drug Product manufacturing for Hospira’s biosimilar products.

“Schauer is a versatile leader and scientist with a solid background in managing large teams in the identification and development of disruptive new technologies” noted Tom Callaway, MD, Founder and President of Life Science Partner.  “With his global knowledge and reach, he will serve Hospira well in its mission to become a global leader in providing biosimilar versions of the world’s most critical biological drugs.”

Schauer earned a Bachelor of Science in Biochemistry and Biology and his PhD in Anaerobic Microbiology from the Virginia Polytechnic Institute, Blacksburg.

/0 Comments/by

Lisa Becker joins AGA Medical as Senior Director of Regulatory Affairs

Life Science Partner recruits former Director, Worldwide Regulatory Affairs at Boston Scientific

Life Science Partner announces the recruitment of Lisa Becker, a senior medical device regulatory executive, to become Senior Director of Regulatory Affairs for the AGA Medical Corporation.

AGA Medical 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.

In her most recent role at Boston Scientific, Becker served as Director of Worldwide Regulatory Affairs for the Cardiac Rhythm Management Division.  During Becker’s long tenure at Guidant/Boston Scientific, she served in numerous regulatory leadership roles of increasing responsibility for the company.  Becker’s early career was spent in the U.S Air Force as a Military Personnel Flight Commander.

“Lisa is an articulate and passionate leader who has built both small highly efficient regulatory teams and managed large complex international regulatory organizations,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “She has an impressive track record of creating innovative systems which utilize data-driven metrics to accelerate the regulatory approval process.”

Becker earned a Bachelor of Science degree in Organizational Behavior with General Engineering Minor from the United State Air Force Academy and a Master of Science degree in Human Resource Management and Information Systems from Chapman University.

Learn More About Chief Medical or Regulatory Leaders
/0 Comments/by

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.

Learn More About Chief Medical or Regulatory Leaders
/0 Comments/by

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.

/0 Comments/by

Gene Jung joins the Global Cardiovascular Innovation Center as Senior Director of Product Development

Life Science Partner recruits Senior Cardiovascular Product Development Executive.

Life Science Partner announces the recruitment of Gene Jung, formerly Vice President of Engineering at ProRhythm, to the newly created Global Cardiovascular Innovation Center (GCIC) based in Cleveland, Ohio.

Headquartered on the campus of The Cleveland Clinic, GCIC was launched with a $60 million grant for the State of Ohio to develop and commercialize new cardiovascular products.  GCIC will utilize the considerable clinical, research and commercialization capabilities of the GCIC member organizations in northeast Ohio and focus on developing technologies in partnership with established cardiovascular-focused companies and in newly-formed start-up companies.

In Jung’s most recent role at ProRhythm, he was responsible for developing the company’s High Intensity Focused Ultrasound (HIFU) technology into a commercial product for Atrial Fibrillation.

Previously, Jung was a Medical Device Consultant in Tokyo where he designed and developed intra-vascular coronary products for numerous Japanese Medical Device Companies.   Prior to his work in Japan, Jung served as Research and Development Director at the Image Guided Therapy Division at Jomed Corporation in San Diego.

“Jung has a broad view of medical device technology from early-stage physician-driven innovation though product commercialization,” noted Tom Callaway, MD, founder and president of Life Science Partner. “His extensive technical leadership background across multiple cardiovascular platforms and his strong industry and physician networks will serve GCIC well.”

Jung earned his Bachelor of Science Degree in Mechanical Engineering from the University of Arizona in Tucson, AZ.

/0 Comments/by

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.

Learn More About Chief Medical or Regulatory Leaders
/0 Comments/by

William F. Wright to join Osiris Therapeutics, Inc. as Senior Director, Osteocel and Mesenchymal Stem Cell Operations

Life Science Partner recruits former General Manager of PBM Nutritionals, LLC (formerly Wyeth Nutritionals)

Life Science Partner announces the recruitment of Bill Wright, a senior manufacturing executive, to Osiris Therapeutics, Inc. as the Senior Director,  Osteocel and Mesenchymal Stem Cell (MSC) Operations.   

Osiris Therapeutics develops innovative technology for isolating and expanding mesenchymal stem cells derived from donated bone marrow for therapeutic drug products. The Company uses cells from adult donors that are grown in culture to very high numbers, allowing a single donor’s cells to treat thousands of patients. 

These cells can be used in patients unrelated to the donor, without rejection, eliminating the need for donor matching and recipient immune suppression.

In Wright’s most recent role at PBM, a manufacturer of infant formula and other nutritional foods, he was responsible for the strategic direction and operational results for all aspects of this high growth entrepreneurial business including managing the functions of quality, commercial operations, engineering, HR, finance, IT, R&D and manufacturing. 

In his previous position at CryoLife, Inc., he served as Director of Operations for Bioprosthetic Devices and Allograft Processing.

“Bill has strong operations skills, understands how to scale up biological sites and is well-versed in broad device operations making him an excellent fit for this critical role as Osiris readies for its upcoming Phase III trials in both GVHD and Crohn’s Disease indications,” noted Tom Callaway, MD, founder and president of Life Science Partner.

Wright will lead all aspects of manufacturing operations with the responsibility for developing, approving and implementing the strategic and operational plans of the organization, for championing quality improvement initiatives, and sponsoring business excellence efforts.

Wright received his Bachelor of Arts degree from Erskine College in Due West, South Carolina.

Learn More About Life Science Partner

Click button below to learn more about how we recruit Chief Executives:

Learn More About Chief Executive Functions
/0 Comments/by

Dr. Jerry Fernandez to Join Aureon Biosciences as Senior Director of Pathology

To lead a team developing novel diagnostic services and products for prostate cancer patients

Life Science Partner announces the recruitment of Dr. Gerardo “Jerry” Javier Fernandez, an anatomic pathologist, to Aureon Biosciences. 

Aureon is a Yonkers, New York-based company enabling personalized patient care utilizing systems pathology to develop predictive clinical tests for cancer care, as well as to enable biopharmaceutical research and development.

Fernandez was recruited from Genzyme Genetics where he was an anatomic pathologist providing referring physicians with highly specialized referral services.  Dr. Fernandez is interested in computer-assisted diagnostics and led the company’s imaging applications and interactive analysis group.  Most recently, he was a core team member and the medical consultant for the information system consolidation between laboratory and surgical pathology.

“Jerry is unique in that he is an anatomical pathologist whose keen interest in using computers for improving patient care is his passion,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “Aureon will allow him to lead a team developing the latest tool set for cancer diagnostics and turn data into knowledge by the strategic use of computer imaging and integrating patient information.”

Dr. Fernandez will lead a team of four anatomical pathologists interrogating and analyzing tissue to provide the first comprehensive and fully integrated view of the progression of cancer by studying multiple molecular pathways of disease as well as micro-anatomic imaging.  By utilizing state-of-the-art informatics, Aureon Biosciences will be able to provide referring physicians some of the first predictive tests for cancer by integrating molecular pathology and clinical informatics.

Dr. Fernandez received his MD from the Medical College of Pennsylvania and his undergraduate degree in Natural Science and Mathematics at Bennington College.  He completed his residency in Anatomic/Clinical Pathology and his fellowships in Cytopathology and Surgical Pathology at New York University Medical Center.

/0 Comments/by

Proxima Hires Webster for Senior Product Development Position

Life Science Partner connects experienced medical product engineer with radiation delivery systems company:

Life Science Partner announces the placement of R. Michael Webster as senior director of product development at Proxima Therapeutics in Alpharetta, Georgia. In this new capacity, Webster assumes overall responsibility for the development and improvement of products based upon the company’s proprietary delivery system. He will oversee a team of engineers as well as external engineering and manufacturing resources. Proxima Therapeutics, a privately held medical device company, develops innovative radiation delivery systems for the treatment of solid cancerous tumors.

“Michael is regarded by his peers—and the engineers who have served on his teams—as an excellent manager,” says Life Science Partner Vice President Cynthia B. Roberts. “With his start-to-finish engineering expertise from design and development through manufacturing, he’ll prove a strong asset for Proxima.”

Webster is an accomplished project manager with a 17-year career spent engineering balloon and other catheters as well as radiation therapy products. Prior to joining Proxima, Webster was group manager, research and development at Novoste Corporation in Norcross, Georgia. At Novoste, Webster guided strategy, scheduling, budgeting, product development conformity, quality protocols and regulatory efforts.

As program manager with the Balloon Catheter/Stent Delivery Systems Group at Cordis Corporation in Miami Lakes, Florida, Webster led engineering activities on multiple PTCA/PTA delivery system projects. His responsibilities included physician opinion evaluation, product design, competitive product analysis, and portfolio strategies.

Webster initiated his medical device career at North American Instrument Corporation (NAMIC), Glens Falls, New York, where he was senior manufacturing engineer in the project engineering department. With NAMIC, he was task team leader for new product and automation projects including an inflation device for cardiology, radiology drainage bag manufacturing, an introducer sheath, and many more.

During a combined seven years at Coleco Industries and Ingersoll-Rand, Webster also worked as an engineer focused on consumer products and power tools manufacturing.

About Life Science Partner Executive Search

Life Science Partner’s high-quality executive and scientific recruiting services target the very specific needs of life sciences and healthcare organizations. We identify and recruit the brightest talent in the biotechnology, pharmaceutical, medical device and healthcare services fields.

/0 Comments/by