Tag Archive for: Director

Suso Platero, PhD, to become Division Director of Molecular Genetics and Pathology at the FDA’s Office of Health Technology 7

Life Science Partner has recruited Suso Platero, PhD, to become Division Director of Molecular Genetics and Pathology at the FDA’s Office of Health Technology 7 (OHT7).

In this role, Dr. Platero will oversee the regulatory evaluation of molecular diagnostic products and companion diagnostics, ensuring rigorous scientific and regulatory standards are applied to cutting-edge innovations in oncology, immuno-oncology, and rare diseases. 

Suso Platero, PhD

In this role, Dr. Platero will oversee the regulatory evaluation of molecular diagnostic products and companion diagnostics, ensuring rigorous scientific and regulatory standards are applied to cutting-edge innovations in oncology, immuno-oncology, and rare diseases. 

Platero has over twenty years of experience in drug discovery, diagnostics, and precision medicine. As the former Chief Scientific officer at Discovery Life Sciences and Vice President of Biomarkers and Companion Diagnostics at Vertex Pharmaceuticals, he developed biomarker-driven strategies to support clinical trials and regulatory submissions.   

Career Highlights and Contributions

Platero has over twenty years of experience in drug discovery, diagnostics, and precision medicine.

As the former Chief Scientific officer at Discovery Life Sciences and Vice President of Biomarkers and Companion Diagnostics at Vertex Pharmaceuticals, he developed biomarker-driven strategies to support clinical trials and regulatory submissions.   

Platero has always been on the cutting edge of developing companion diagnostics. At Janssen Pharmaceuticals, he led the team that discovered and developed the companion diagnostic for Balversa©, approved by the FDA. 

At LabCorp and Covance, Dr. Platero created and headed the Biomarker Solutions Center, where he led a team responsible for developing and commercializing companion diagnostics for global regulatory approval. 

“Platero joins a team of leaders that we have recruited for FDA oversight of this rapidly changing field of IVD diagnostics,” notes Tom Callaway, MD, MBA, Founder of Life Science Partner.  “Throughout his career, Dr. Platero has collaborated with key opinion leaders and regulatory agencies to accelerate the development of precision medicine approaches in oncology and immunology.”

Dr. Platero holds a PhD in Cell and Molecular Biology from St. Louis University, where he focused on the functional analysis of chromatin domains in eukaryotic cells. He also earned a Master of Science in Cell Biology and Molecular Biophysics from Columbia University and a Bachelor of Science in Chemistry and Microbiology from the University of Pittsburgh.

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA:

FDA Regulatory Leadership For Medtech/IT Convergence

Life Science Partner has partnered with the FDA to recruit leaders that can create innovative pathways for early-stage companies to be better prepared for the regulatory review and clearance process. In close collaboration with Jeff Shuren, MD, JD, Head of the Center for Devices and Radiological Health (CDRH) for the FDA, Life Science Partner recruited Doug…

Read More

Something went wrong. Please refresh the page and/or try again.

/0 Comments/by

Christine Vietz to become Deputy Office Director, Personalized Medicine | FDA

Life Science Partner has recruited Christine Vietz, PhD, formerly Senior Vice President of Product Development at Foundation Medicine, to become the Deputy Office Director, Personalized Medicine, for the FDA’s CDRH OHT 7 (In Vitro Diagnostics).

Vietz will oversee the 60+ person Division of Molecular Genetics and Pathology, and will continue to build out the emerging organization of regulatory scientists  comprising the Personalized Medicine Team.

As the leader of the Personalized Medicine Team, she will also serve as a liaison to the medical device industry, as well as to the scientific and healthcare communities for personalized medicine related issues.

Christine Vietz, PhD FDA

Under Vietz’s leadership, OHT7 seeks to grow its expertise in genetically based disease diagnosis and identification of targets for therapeutic intervention.

Vietz has over 20 years of leadership experience across diagnostic assay development, regulatory affairs, and clinical laboratory operations. 

Under Vietz’s leadership, OHT7 seeks to grow its expertise in genetically based disease diagnosis and identification of targets for therapeutic intervention. Vietz has over 20 years of leadership experience across diagnostic assay development, regulatory affairs, and clinical laboratory operations. 

Career Highlights and Contributions

Before joining the FDA, Dr. Vietz served as Senior Vice President of Product Development at Foundation Medicine. Her leadership enabled the company to achieve multiple industry firsts, including securing FDA approval for the FoundationOne CDx pan-tumor comprehensive genomic profiling assay under the Breakthrough Devices Program.

During her tenure at Foundation Medicine, she developed the regulatory strategy and built the diagnostic development teams that continued to expand Foundation Medicine’s IVD portfolio with approval of the liquid biopsy assay, FoundationOne Liquid CDx, as well as the many subsequent companion diagnostic claims added to the approved assays over the subsequent years. 

“Christine stands out in her extraordinary ability to bring cutting-edge diagnostics tied to biopharmaceuticals development through the regulatory process,” said Tom Callaway, MD, founder of Life Science Partner. “Patients will have better outcomes thanks to the FDA’s forward-thinking, particularly in this era of AI and personalized therapeutics.“

Vietz earned her PhD in Biomedical and Medical Engineering and her Bachelor of Science in Chemical Engineering from the University of Rochester. Vietz’s commitment to innovation, regulatory excellence, and operational efficiency makes her uniquely suited for her new leadership role at the FDA.

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA:

David McMullen, MD, Recruited as Director, Office of Neurological and Physical Medicine Devices (OHT5), FDA Center for Devices and Radiological Health (CDRH)

Life Science Partner has recruited David McMullen, MD, to serve as Director for The Office of Neurological and Physical Medicine Devices (OHT5), Center for Devices and Radiological Health (CDRH) at the Federal Drug Administration.  The CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring…

Read More
/0 Comments/by

Ross Segan, MD, to Become FDA CDRH’s Office Director, Product Evaluation & Quality

Life Science Partner has recruited Ross (Rusty) Segan, MD, formerly Chief Medical Officer of Olympus and Integrated Leader, Pre-Clinical, Clinical, and Medical Affairs at DuPuy Synthes, to the FDA to become Director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health (CDRH).

Segan’s New Role and Responsibilities at the FDA

In this role, Dr. Segan is responsible for setting the strategy and overseeing Device-Specific Offices, the Office of Clinical Evidence and Analysis, and the Office of Regulatory Programs. His leadership ensures quality end-to-end device evaluation and consistent interpretation and application of regulatory policy and guidance.

Ross "Rusty" Segan, MD, FDA CDRH's Office Director, Product Evaluation & Quality

With his extensive background in medical and scientific affairs, Dr. Segan brings a wealth of experience from his global leadership roles at Olympus, Johnson & Johnson, and Covidien, where he led the development and implementation of clinical and regulatory strategies that significantly improved clinical outcomes and upheld patient safety.

Career Highlights and Contributions to the Medical Device Industry

Before joining the FDA, Dr. Segan held several prominent positions in the medical device industry. As Chief Medical Officer of Olympus, he was pivotal in driving the company’s medical safety initiatives and fostering innovation across the global portfolio. At Johnson & Johnson’s DuPuy Synthes, he led Pre-Clinical, Clinical, and Medical Affairs for the $9 billion orthopedic and medical device division.

His career also includes leadership roles at Covidien, overseeing a diverse portfolio of clinical studies, healthcare economics, and reimbursement strategies. Across these roles, Dr. Segan consistently demonstrated his ability to integrate business strategy with scientific excellence, driving transformation in medical technologies that improved patient care worldwide.

“Rusty brings a wealth of experience in science, medicine, and, most importantly, organizational leadership,” said Thomas Callaway, MD, Founder of Life Science Partner.  His former colleagues widely praised his management skills, an asset that will help him succeed in leading the teams and infrastructure within the FDA’s CDRH. 

Dr. Segan’s educational background complements his extensive career in the medical technology industry. He earned his Medical Doctor degree from UMDNJ-Robert Wood Johnson Medical School and holds a Master of Business Administration with specializations in Entrepreneurship, Innovation, and Leadership from New York University’s Stern School of Business.

Before his medical education, Dr. Segan earned a Bachelor of Science from Salisbury State University and a Master of Science in Athletic Training from West Virginia University. 

His clinical training includes general surgery residencies at Thomas Jefferson University Hospital and Cooper Hospital/University Medical Center and a clinical fellowship in minimally invasive surgery at the University of Maryland.

This diverse academic background has equipped Dr. Segan with a unique combination of medical, business, and leadership expertise, enabling him to excel in advancing healthcare technology and regulatory practices globally.

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA:

/0 Comments/by

Troy Tazbaz joins the FDA to lead the Digital Health Division and Center of Excellence

Former Oracle SVP, Troy Tazbaz will lead the effort to advance AI and ML for healthcare and help orchestrate a new regulatory environment for digital healthcare.

Life Science Partner announces the recruitment of the FDA’s new Division Director for Digital Health and Director for the Digital Health Center of Excellence to prepare the agency to partner with innovators and create regulatory guidance for the application of Artificial Intelligence within the convergence of healthcare IT and medical devices.

Formerly, the Senior Vice President, Industry Business Unit for Oracle, Troy Tazbaz will step into this new critical role created within the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health (CDRH).

Troy Tazbaz

“A thought-leader within the integrated world of cloud-based AI technology, Tazbaz is a thoughtful problem solver with a track record of successfully bridging multiple constituencies to accelerate AI adoption to improve efficiencies including patient care outcomes”

Tom Callaway, MD, Founder of Life Science Partner

Tazbaz will partner with a broad range of national and global government agencies, institutions, academia, and various organizations representing patients, consumers, and healthcare professionals. Tazbaz will be responsible for building the FDA’s key resources for establishing digital health guidelines and efficient regulatory pathways for the integration of digital and cloud-based technologies.

Tazbaz joins the FDA after recently serving as Senior Vice President of Strategy and Operations for Industry Business Unit responsible for developing Oracle’s industry-specific operating technologies. Earlier in his tenure at Oracle, he led various strategic initiatives such as global cloud data center expansion planning, developing Oracle’s industry strategy, and the launching of Healthcare Business Unit.  

Life Science Partner is pleased to continue their partnership with the Center for Devices and Radiological Health at the FDA on leadership projects underway for the Office of Product Evaluation and Quality.

About Life Science Partner

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 information technology fields.

Learn More About Chief Medical or Regulatory Leaders

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA:

/0 Comments/by

David McMullen, MD, Recruited as Director, Office of Neurological and Physical Medicine Devices (OHT5), FDA Center for Devices and Radiological Health (CDRH)

Life Science Partner has recruited David McMullen, MD, to serve as Director for The Office of Neurological and Physical Medicine Devices (OHT5), Center for Devices and Radiological Health (CDRH) at the Federal Drug Administration. 

The CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

David McMullen, MD

The Office of Health Technology 5 (OHT5) is within CDRH’s Office of Product Evaluation and Quality (OPEQ) and is responsible for the total product life cycle review of neurological and physical medicine devices.

As Director for OHT5, McMullen will serve as the technical authority and principal advisor to the OPEQ Director on the total product lifecycle of devices including premarket evaluation, compliance and quality, and surveillance programs for neurological products. 

Career Highlights and Contributions

Since 2016, McMullen has served as the Program Chief for the National Institute of Mental Health (NIMH) within the Neuromodulation and Neurostimulation Program, Division of Translational Research (DTR).

His oversight included device development and biomarker discovery grants as well as clinical trials ranging from first-in-human to critical studies designed to gain FDA regulatory approval. McMullen’s experience includes acting as co-leader for the NIH BRAIN Initiative team and as the NIMH point of contact to the FDA on devices.

“McMullen’s neurovascular and neurostimulation expertise combined with his working relationships within the FDA make him a natural fit for his new leadership role at the Office of Neurological and Physical Medicine Devices,” states Tom Callaway, MD, MBA, Founder of Life Science Partner.

In his new role at OHT5, McMullen will be tasked with navigating the complexities and multiple constituencies of the FDA’s neuroscience device regulatory division and industry agencies while managing a 90 plus person office.

McMullen earned his Bachelor of Science degree in Psychology and Neuroscience from Duke University and his Doctor of Medicine from Rutgers Robert Wood Johnson Medical School.

About Life Science Partner Executive Search

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 in medicine, science, and industry enable us to efficiently deliver the brightest candidates in the medical device, biopharmaceuticals, diagnostics, and healthcare technology fields.

Learn More About Chief Medical or Regulatory Leaders

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA:

/0 Comments/by

Doug Kelly, MD, MBA Joins FDA’s Center for Devices & Radiological Health as Deputy Director for Science

Life Science Partner is pleased to announce the recruitment of Doug Kelly, MD, MBA as Deputy Director for Science to the Food and Drug Administration’s Center for Devices and Radiological Health (FDA, CDRH).

FDA, CDRH is responsible for protecting and promoting public health by assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

They provide the community with accessible science-based information about the products they oversee and facilitate medical device innovation by advancing regulatory science.

Doug Kelly, MD, MBA

The CDRH also provides industry with predictable, consistent, and transparent regulatory pathways to assure consumer confidence in the devices marketed in the United States.

With the tremendous advancements in technology and a new age for telemedicine and remote patient monitoring, the CDRH is also focusing on advancing their field of digital health. Housed within the CDRH is the Office of Strategic Partnerships and Technological Innovation.

This unit provides leadership for all scientific collaborative and emerging technology, including the new division of Digital Health, which focuses on providing leadership and oversight in the development, review, and implementation of new software services that are aimed at healthcare.

Career Highlights and Contributions

Doug Kelly is a leader in the field of innovative medical technologies. After earning his medical degree from Albert Einstein College of Medicine and his MBA from Stanford University, Kelly was one of the founding members of Ligand Pharmaceuticals, where he served as the Manager of Business Development and helped recruit their Scientific Advisory Board and manage relationships with corporate partners.

In 1996, he helped create a new venture fund, Alloy Ventures, and identified new opportunities for investments in seed- and later-stage medical device, drug discovery, biotechnology and healthcare IT companies.

Dr. Kelly will play a critical, external-facing role for the CDRH and the Office of Strategic Partnerships and Technological Innovation by collaborating with leaders in industry, academia, and healthcare innovation, leveraging his wealth of experience in the medical device investment community.

About Life Science Partner

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.

Learn More About Chief Medical or Regulatory Leaders

Read More About Life Science Partner’s Recruitment for the FDA

Here are some of featured Press Releases that describe our executive placements and involvement with the FDA:

/0 Comments/by

Nora York Joins Canary Medical as Senior Director, Regulatory & Quality Assurance

Life Science Partner is pleased to announce the recruitment of Nora York to join Canary Medical as Senior Director of Regulatory & Quality Assurance.

Canary Medical is an innovative medical technology company commercializing smart implants in the orthopedic, cardiovascular, and aesthetic markets. The company integrates a sensor and microprocessor system into FDA-cleared implantable medical devices to generate real-time insights about the performance and safety of these products.

York will be responsible for developing Canary’s regulatory strategy in concert with the other leaders of the team. Her role will involve implementation, oversight, and maintenance of Canary’s regulatory affairs organization.

Nora York

Before joining Canary, York was the Director of Regulatory Affairs & Quality Assurance for SynergEyes, an advanced technology specialist company for hybrid contact lenses. She also spent two years as the Head of Regulatory Affairs for Philips Volcano Corporation in San Diego, where she was in charge of the development and execution of regulatory strategy and submission of several 510(k) applications for the company’s Image-Guided Therapy systems.

“York is a proven performer in quality and regulatory circles in Southern California” notes Tom Callaway, President of Life Science Partner. “Her recruitment to this emerging team will ensure the processes and rigor required in innovative implantable devices.”

York earned her bachelor’s degree in Biology at the University of Texas in Dallas.

About Life Science Partner

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.

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

Fred Siebert Joins Beckman Coulter as Director, Global Clinical Affairs

Life Science Partner is pleased to announce the recruitment of Fred Siebert to Beckman Coulter as Director, Global Clinical Affairs. Beckman Coulter is an innovative diagnostics and life science company that creates the world’s most efficient diagnostic laboratories. It is part of the Danaher group of families.

In this new role, Siebert will be responsible for the development and execution of a consolidated global clinical trials strategy for the company. This work is of particular importance to the company in the context of changing European regulatory requirements and continued growth of the company’s clinical activities in Asia.

Siebert brings deep experience in global clinical trials for molecular diagnostics and biopharmaceuticals, most recently at OvaScience, where he oversaw their clinical programs as Vice President of Clinical Operations.

Earlier in his career, Siebert held a variety of clinical affairs leadership roles at Abbott Molecular, where he led the company’s first companion diagnostics partnership and earned the Abbot Chairman’s Award for his contributions.

“Fred in in a great position to leverage his clinical insights and global diagnostics experience to further Beckman Coulter’s global leadership in IVD,“ notes Tom Callaway, MD, President and Founding Partner at Life Science Partner. “We look forward to seeing the continued growth and geographical expansion of the company’s clinical programs under his able leadership.”

Siebert earned a BSc in Medical Technology  from Eastern Kentucky University.

About Life Science Partner Executive Search

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.

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

Barbara Benedict Joins Notal Vision as Director, Patient Engagement

Life Science Partner is pleased to announce the recruitment of Barbara Benedict to Notal Vision as Director of Patient Engagement.

Notal Vision is a tele-health company offering the first patient-initiated, home-based monitoring system to prevent the progression of macular degeneration through early detection and intervention. The technology combines a physical device with a data management infrastructure and a cloud-based physician monitoring system.

In her new role, Benedict will have broad responsibility over all operational aspects of the customer experience, developing key patient engagement strategies and ensuring an exceptional experience for patients and their caregivers.

Previously, Benedict led customer engagement and marketing at Conifer Health, the healthcare management services subsidiary of Tenet Health. Prior to joining Conifer Health Solutions, Benedict spent 4 years in enterprise physician marketing and communications for BayCare Health System, a health care system connecting patients to a wide range of services at 14 hospitals throughout central Florida. She also spent three years as Director, Customer Relations, Marketing and Operations at Healthcare Partners, which manages and administers healthcare products for contracted health plans. Here she led operations for a large multi-specialty medical clinic including a comprehensive customer relations program and community engagement program.

“Barbara has demonstrated she knows how to use remote monitoring technologies to keep patients well, and that she can build and enact a strategy for ensuring these patients are engaged and supported throughout the entire patient journey,” notes Tom Callaway, MD, MBA, President of Life Science Partner. “Her blend of patient-centered empathy and healthcare operations rigor make her a great match for this important role.”

Benedict earned a degree in Marketing and Business Development from the University of South Florida.

About Life Science Partner Executive Search

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.

Learn More About Chief Executive Functions
/0 Comments/by

K2M Recruits Caitlyn Seidl to be Director, Clinical & Regulatory Affairs

Life Science Partner is pleased to announce the recruitment of Caitlyn Seidl to K2M, where she will serve as Director, Regulatory & Clinical Affairs.

Based in Leesburg, Virginia, K2M is a medical device company focused on creating tools and implants for minimally-invasive spine surgery. The company is a leader in the 3D printing of spinal implants for deformity (especially scoliosis), trauma, and tumor operations. Reporting to the Senior Vice President of Global Quality and Regulatory Affairs, Seidl will be responsible for directing global clinical outcomes research programs and the global regulatory process for K2M’s product portfolio.

Previously, Seidl served as Manager, Clinical Affairs for the Critical Care division of Edwards Lifesciences, a leader in artificial heart valves and related technologies. Seidl has also held clinical affairs leadership positions with Exactech (orthopedic devices), Axogen (biologics), and Cardioquest (cardiovascular research). She brings to K2M more than a decade of clinical and regulatory affairs leadership including trials in spinal orthopedics.

“Caitlyn impressed us as a leader with both the technical acumen in clinical trials for spinal orthopedic devices and the team management skills to ensure the group’s clinical studies faithfully convey the value K2M’s technologies bring to patients,” shared Tom Callaway, MD, MBA, President of Life Science Partner. “She will be a great asset to K2M and we look forward to seeing her impact over the coming years.”

Seidly earned her bachelor’s degree in Biomedical Sciences from the University of South Florida.

About Life Science Partner Executive Search

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.

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