Tag Archive for: Regulatory

Nigel Wilkinson Joins EndoChoice as Vice President, Quality and Regulatory

Former Senior Vice President, Quality and Assurance at Smith & Nephew

Life Science Partner recruited Nigel Wilkinson, a seasoned quality assurance executive to become the Vice President, Quality and Regulatory for EndoChoice.

In his new role, Wilkinson will be responsible for managing a global quality and regulatory organization in the United States, Germany, and Israel. Wilkinson will report to the Chief Executive Officer, Mark Gilreath.

“Smart. Polished. Articulate.  I believe that Wilkinson is the prototype of the senior quality and regulatory leader,” states Tom Callaway, MD, President of Life Science Partner.  “He has built and led a global quality affairs organization and has extensive track record of achieving business objectives while successfully balancing regulatory requirements.”

Prior to his new position at EndoChoice, Wilkinson spent much of his career at Smith & Nephew where he played a critical role in merging the new Advanced Surgical Devices Division with the previous Orthopedic and Endoscopy Divisions.

Wilkinson earned his Bachelor of Science Degree in Microbiology and Genetics from the University of London, England.

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Jesse McCool, PhD, Joins Cytovance Biologics as Vice President, Microbial Services

Former Director, Process Development at Lonza Biologics

Life Science Partner recruited Jesse McCool, an innovative and energetic R&D leader, to become Vice President, Microbial Services for Cytovance Biologics.

Founded in 2003, Cytovance is one of the premier biological contract companies of therapeutic proteins and antibodies from mammalian cell culture to microbial fermentation.

“Jesse brings considerable new microbial cell development savvy and strong leadership skills to help build out this new product line for Cytovance,” said Tom Callaway, MD, President of Life Science Partner.  “His enthusiasm is infectious.”

In his new role at Cytovance, McCool will report to the Chief Scientific Officer and will direct microbial biologics process discovery and development activities.  He will manage partnerships with client organizations to assure strategic and tactical efforts are executed in accordance with global biologics regulatory submissions.

During his tenure at Lonza, McCool was successful in expanding offerings in Microbial Process R&D Services and improving Lonza’s market presence as Director, Microbial Process Development.

McCool earned his Bachelor of Science Degree and PhD in Microbiology from the University of Massachusetts at Amherst.

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Courtney Barton Joins Allergan – Director, Corporate Compliance

Former Director, Corporate Compliance & Global Data Privacy at Bausch & Lomb

Life Science Partner recruited Courtney Barton, an experienced global compliance executive, to become Director, Corporate Compliance for Allergan Medical.

In her new role, Barton will be responsible for leading compliance with CIA directives and developing Allergan’s compliance policies for the $1.4B medical device businesses.  Barton will report to the Vice President and Deputy Director Wes Porter.  Porter was recruited by Life Science Partner to Allergan in 2012.

Prior to her new position at Allergan, Barton spent much of her career at Bausch & Lomb where she played a key role in building and maintaining the Company’s current Compliance Program.

Barton earned Bachelor of Arts in International Relations and Political Science from Syracuse University.

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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.

Recruiting Transformational Leaders

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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Richard Pellegrino Joins K2M Inc. as Vice President, Advanced Technology Development

Life Science Partner recruits former Vice President, Research and Development of Relievant Medsystems

Life Science Partner announces the recruitment of Richard (Rick) Pellegrino to become Vice President of Advanced Technology Development for K2M.

Richard Pellegrino K2M VP

“Pellegrino is technically sound, an excellent manager, and a scrappy entrepreneurial inventor,” noted Tom Callaway, MD, Founder and President of Life Science Partner.  “He is passionate and articulate about platform technologies and their applications.”

Welch Carson has recently acquired K2M, an innovative spinal device company committed to the research, development, and commercialization of solutions for the treatment of spinal pathologies and procedures.

In his new role at K2M, Pellegrino will lead a team of engineers for developing new spinal technologies in-house.  He will also be working with spine surgeons to build customized products for specific needs.

Pellegrino was the inventor of the core technology of Relievant Medsystems, a company that specializes in developing technology targeting the source of chronic low back pain. In this role, Pellegrino was responsible for all facets of research, product design, engineering, and clinical development and recruited a world-class scientific advisory board.

Previously Pellegrino served as Staff Researcher and Development Engineer in three Johnson & Johnson companies; DePuy Spine, Ethicon, and Cordis.

Pellegrino earned a Bachelor of Science degree in Mechanical Engineering Technology from Wentworth Institute of Technology in Boston, Massachusetts.  He also earned his associates degree in Applied Science and Mechanical Design from Wentworth Institute of Technology.

About Life Science Partner

Life Science Partner’s high-quality executive, research and professional placement 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, academic and healthcare services fields.  Our combined scientific backgrounds and senior management experience give us the scientific literacy and business knowledge to help us better understand challenges, refine requirements and work more effectively with our life science clients.

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Tina Webb Joins Allergan as Director, Business Compliance, Pharmaceuticals

Life Science Partner recruits former Associate Director, US Pharmaceuticals Compliance and Ethics for Bristol-Myers Squibb

Allergan, Inc. is a technology-driven, multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices in the areas of eye care, neurosciences, medical dermatology and urologics. The company is best known for its Botox franchise.

Tina Webb, an experienced pharmaceutical compliance executive, has joined Allergan as the Director of Business Compliance, Pharmaceuticals. 

In this role, she will be responsible for providing advice and leading efforts regarding Allergan’s compliance policies and procedures for the pharmaceutical business within the United States.  She will work with the sales force to build communication strategies and messages that are effective but consistent with the product’s approved uses – and create solutions that enhance physician customer relations with the CIA guidelines.

In her previous role at Bristol-Myers Squibb, Webb was responsible for developing, overseeing and maintaining the Company’s US Compliance and Ethics program.  She successfully brought automation and systemization of the compliance program that allowed the sales and marketing organization to function more effectively while in compliance.

“Tina has an analytical and legal approach to compliance combined with a sales-oriented personality,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “Her broad experience in creating and implementing compliance programs for US Sales and Marketing organizations will be a great asset for the Allergan Compliance team.”

Webb earned her degree from Rutgers University in New Brunswick, NJ.

About Life Science Partner

Life Science Partner’s high-quality executive, research and professional placement 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, academic and healthcare services fields.  Our combined scientific backgrounds and senior management experience give us the scientific literacy and business knowledge to help us better understand challenges, refine requirements and work more effectively with our life science clients.

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Wes Porter Joins Allergan as Vice President, Deputy Compliance Officer

Life Science Partner recruits Vice President of Ethics and Compliance at CareFusion

Life Science Partner announces the recruitment of Wes Porter, a senior compliance executive and attorney, to become Vice President, Deputy Compliance Officer at Allergan Inc. 

Best known for its Botox franchise, Allergan is a technology-driven, multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices in the areas of eye care, neurosciences, medical dermatology and urologics.

In Porter’s previous role at CareFusion, a leading global medical technology company headquartered in San Diego, he helped build the de novo compliance organization for the $4 billion revenue spin off from Cardinal Health.  He was most recently responsible for global compliance programs for both the Procedural Solutions and Medical Systems operating segments for the company.  Prior to joining CareFusion, Porter served as the global compliance lawyer for all four Smith & Nephew business units, managing complex internal and external investigations for the company.

“Wes is smart, aggressive, and has worked diligently to build teams as evidenced by his success in career progression and scope of responsibility,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “He leads a team that Life Science Partner has helped recruit in partnership with Rose-Karen Swanson, Chief Compliance Officer, to transform the business as required by the Company’s 2010 Compliance Integrity Agreement.”

Porter earned his degree in History at Occidental College in Los Angeles, CA, followed by earning his Masters in Health Administration and Juris Doctorate from St. Louis University in St. Louis, MO.

About Life Science Partner

Life Science Partner’s high-quality executive, research and professional placement 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, academic and healthcare services fields.  Our combined scientific backgrounds and senior management experience give us the scientific literacy and business knowledge to help us better understand challenges, refine requirements and work more effectively with our life science clients.

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Cathy Srebalus-Barnes, PhD Joins Hospira as Senior Director, Bioanalytical Sciences

Former Director, Bioproduct Analytical Development at

Eli Lilly and Company

Life Science Partner announces the recruitment of Cathy Srebalus-Barnes, PhD, an experienced bioanalytical executive, to become Senior Director, Bioanalytical Sciences, Global Biologics R&D for Hospira, Inc.

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 her new role at Hospira, Inc., Srebalus-Barnes will lead a global scientific team responsible for bioanalytical method development and bioanalytical characterization activities supporting Hospira’s growing biosimilars pipeline.

Srebalus-Barnes has spent much of her career at Eli Lilly and Company, where she was most recently responsible for leading three teams of scientists that included Analytical Development, Trace Analysis and Bioassay groups.  She oversaw the complete downstream process for Phase II – ready for III preparation for therapeutic biotechnology products in clinical and commercial development.  Previously, Srebalus-Barnes served as Director, Bioprocess Virology and Purification Development, where she was responsible for two groups managing the purification process development and viral safety procedures for all biotechnology products in development.

Barnes earned a Bachelor of Science Degree in Chemistry from West Virginia University and her Doctorate from Indiana University in Analytical Chemistry.

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Nancy Grygiel joins Allergan as Senior Director, Corporate Compliance, International

Life Science Partner recruits former Director of Global Compliance Program at Mylan Pharmaceuticals

Life Science Partner announces the recruitment of Nancy Grygiel, an experienced global compliance executive, to Allergan, Inc. to become Senior Director, Corporate Compliance, International for the company.

Allergan is a technology-driven, multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices in the areas of eye care, neurosciences, medical dermatology and urologics.

In Grygiel’s previous role at Mylan Pharmaceuticals, a Pennsylvania-based company developing generic and specialty pharmaceuticals, she was responsible for overseeing the global compliance program operations across North American, Asia Pacific, Europe and Middle East, and India and China.

Prior to joining Mylan, Grygiel practiced as an International Business Transactions and Immigration Specialist at the Law Offices of Paul S. Haar in Washington, DC.

“Nancy is an articulate and passionate compliance officer with a personality and communication skills that allow her to succeed in four languages,” noted Tom Callaway, MD, founder and president of Life Science Partner.  “Her vast international experience and global compliance background will serve Allergan well in its mission to commercialize important new therapies that make a real difference.”

Grygiel earned her degree in Legal Studies from the Universidad De Buenos, Aires and then received her Master of Law Degree from Georgetown Law Center.

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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.

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