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.
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.
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https://i0.wp.com/lifesciencepartner.com/wp-content/uploads/2024/11/christine-vietz.jpeg?fit=400%2C400&ssl=1400400Tom Callawayhttps://lifesciencepartner.com/wp-content/uploads/2024/02/Life-Science-Partner-340-300x138.pngTom Callaway2024-11-04 09:55:442024-11-04 10:16:18Christine Vietz to become Deputy Office Director, Personalized Medicine | FDA
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.
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.
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Clearly outline the Senior Executive position’s qualifications, experience, and responsibilities. Understanding what you need in your future leader is crucial to communicating effectively with the search firm.
2. Specialization and Expertise
Look for a search firm specializing in the healthcare industry with a proven track record of placing high-level executives, particularly in medical or clinical leadership roles. The firm’s understanding of medical credentials, patient care standards, and healthcare regulations will be pivotal.
3. Reputation and References
Research the search firm’s reputation. Ask for references and case studies, mainly where they have recruited similar positions. Speak to previous clients to understand their satisfaction level with the services provided.
4. Recruitment Process and Strategy
Inquire about the firm’s search process, including how they source candidates, their vetting process, and how they handle confidentiality. Understanding their strategy will help you assess whether it aligns with your organization’s needs and values.
5. Candidate Reach and Network
Evaluate the firm’s network and reach within the healthcare sector. A firm with a broad and deep network can more effectively identify and attract top talent who may not actively seek new opportunities but are open to the right ones.
6. Cultural Fit
Ensure the search firm understands your organization’s culture and values. The firm should be able to assess cultural fit, which is as important as professional qualifications for a leadership role.
7. Communication and Reporting
Establish expectations for communication and progress updates. Regular reports and meetings will inform you about the search’s progress and provide insights into the market.
8. Fee Structure and Terms
Review and compare the fee structures of different firms. These can vary significantly, including retained (fixed fee), contingency (payment upon successful hire), or hybrid models. Also, look at their terms regarding guarantee periods for the placement to safeguard your investment.
9. Interview Involvement
Determine the firm’s involvement in the interview process. Some firms offer comprehensive services, including initial screening interviews, interview coordination, and assistance with contract negotiations.
10. Diversity and Inclusion
Consider whether the firm is firmly committed to diversity. This is especially important in healthcare, where leadership should reflect diverse workplace demographics.
By thoroughly vetting potential search firms based on these criteria, you can select a partner who understands your healthcare organization’s specific needs and possesses the expertise to fill this critical role effectively.
Large, Multinational Generalist Search Firms
Electing the right international search firm to find a leader for a healthcare company involves a multi-step process focused on assessing each firm’s global reach, expertise in the healthcare sector, and track record of successful placements.
Below is a breakdown of how you can approach this task:
Before engaging a search firm, clearly define the qualifications, experience, and leadership qualities necessary for the role. This includes understanding the challenges and opportunities the new leader must address within the healthcare sector. Consider the company’s culture, the strategic direction, and how this role fits into the broader organizational goals.
2. Evaluate Global and Local Reach
An effective international search firm should combine a strong global presence with local market expertise. This ensures they have a broad pool of candidates and understand regional regulatory and cultural nuances. Assess their network and their geographic locations, ensuring they align with your company’s presence and growth plans.
3. Check Sector-Specific Experience
The firm should have a solid track record in the healthcare sector. This includes filling leadership roles and understanding ongoing trends, challenges, and innovations in healthcare. Depending on your company’s focus, experience in pharmaceuticals, medical technology, or healthcare services can be precious.
4. Review Success Metrics and Client Testimonials
Look into their success rate in placing healthcare leaders, the longevity of placements, and client satisfaction. Testimonials and case studies can provide insights into their process and success. Also, consider how they measure their performance, such as time-to-hire, retention rates, and the satisfaction of both clients and candidates post-placement.
5. Analyze Their Search Process and Tools
Understanding how the firm conducts its search is crucial. Evaluate their sourcing strategies and assessment tools and how they ensure a fit between the candidate’s leadership style and your company culture. Using advanced technologies and data analytics in their search process can also be a plus, offering more depth in candidate assessment.
6. Discuss Terms and Collaboration Style
Finally, review their contractual terms, fees, and what they encompass, like guarantees for research in case of early departure of a placed candidate. It’s also essential to gauge the firm’s willingness to collaborate closely with your company, understand your needs, and adapt their search accordingly.
Leaders in the Space
Korn Ferry (Los Angeles, USA): Known for its deep expertise in executive search and leadership consulting, Korn Ferry has a significant presence in the healthcare sector. They offer services ranging from executive search to organizational strategy.
Spencer Stuart (Chicago, USA): This firm is renowned for its leadership advisory services and has a strong healthcare practice that helps companies recruit senior executives and board members.
Russell Reynolds Associates (New York, USA): With a global network and a dedicated healthcare sector team, they focus on high-level executive placements and advisory, providing insights into industry trends and leadership dynamics.
Heidrick & Struggles (Chicago, USA) Specializes in senior-level executive search and leadership consulting. Its healthcare practice is well-regarded for understanding client needs and industry challenges.
Egon Zehnder (Zurich, Switzerland): Known for its comprehensive approach to leadership search and assessment, Egon Zehnder offers expertise in healthcare, focusing on long-term placements and sustainable leadership success.
Downsides to Engaging a Large, International Recruiting Firm
Large international search firms often come with significant overhead costs due to their expansive global operations, including multiple offices and a large staff to maintain. While these firms provide a wide array of services and have a broad reach, they typically structure their operations such that senior partners focus on identifying new business opportunities and managing client relationships rather than conducting hands-on recruitment work.
This initial identification and strategic oversight are crucial, but the bulk of the search and vetting process is delegated to more junior associates. These associates handle the day-to-day details of the search, which can lead to variations in the attention and specialization applied to specific sectors such as healthcare.
This structure is designed for efficiency and profit maximization but can sometimes dilute the depth of expertise used for individual searches, particularly in highly specialized fields.
Boutique Firms vs Large International Firms
In contrast, boutique firms specializing exclusively in healthcare often maintain lean operations with lower overhead. This allows them to focus more intensely and stay current on healthcare trends, innovations, and specific talent needs within the industry.
Such firms are typically staffed by professionals who have either come from healthcare backgrounds or have dedicated their careers to understanding and solving the unique challenges of healthcare leadership.
As a result, these specialized firms are more than just profoundly familiar with the technical and cultural nuances of the healthcare sector. Still, they are also more agile in adapting to its rapidly changing environment.
Their specialization ensures that the senior partners, who are often deeply involved in each search, bring expertise and up-to-date industry knowledge that can be critical in identifying and securing exemplary leadership talent. Ultimately, these firms can offer a more personalized and focused search process than their larger, more generalized counterparts.
Choosing the right search firm requires careful consideration of these factors to ensure the selected partner can identify a leader who fills the current role and drives the healthcare company forward in an ever-evolving industry.
Specialized Boutique Firm Considerations
Choosing between a small, specialized recruiting firm and a larger, more diverse firm depends on your organization’s specific needs, priorities, and circumstances.
Here are several scenarios where opting for a small specialized recruiting firm might be more advantageous:
For roles that require highly specialized skills or industry knowledge, such as recruiting a Chief Medical Officer in a medical device company, a specialized firm with deep expertise and networks in the healthcare or medical device sectors would likely be more effective than a more prominent generalist firm.
2. Deep Market Knowledge
Small, specialized firms often have in-depth knowledge of their niche market, including the available talent pool, compensation trends, and the industry’s specific challenges. This can be particularly valuable for roles where industry expertise is critical to the role’s success.
3. Personalized Service and Focus
Smaller firms typically handle fewer clients simultaneously, which can lead to a more customized service. They might offer more attention and a tailored approach to your organization’s needs, culture, and specific requirements for the role.
4. Quality of Candidates
Specialized firms often maintain close relationships with top talent within their niche, including passive candidates who may need to be actively looking but could be persuaded to accept the right opportunity. This can lead to a higher-quality shortlist of candidates.
5. Cultural Fit
Small, specialized firms may be more adept at understanding and integrating your company’s cultural and organizational values into the recruitment process, ensuring that candidates fit the job specifications and the company culture.
6. Efficiency in the Recruitment Process
Given their familiarity with the sector, specialized firms can often streamline the recruitment process, reducing hiring time by quickly identifying and engaging the most relevant candidates.
7. Long-term Relationships and Strategic Partnerships
Smaller firms might be more likely to invest in long-term relationships, understand your business, and become strategic partners rather than just service providers.
When to Choose a Small Specialized Firm
When the role is highly specialized: If the position requires niche skills or industry-specific experience, a specialized firm is likely better equipped to understand and fulfill these requirements.
When industry insight is crucial: In industries like healthcare, technology, or finance, where understanding the market is vital, specialized firms bring valuable insights.
When quality trumps quantity: A specialized firm can be more effective if the focus is on attracting a few highly qualified candidates rather than generating a large volume of resumes.
Choosing a recruiting firm should be based on how well the firm’s capabilities and approach align with the specific needs of the role and your organization’s strategic goals.
In cases where specialized knowledge, a focused strategy, and deep industry connections are crucial, a small, specialized recruiting firm is often the better choice.
https://i0.wp.com/lifesciencepartner.com/wp-content/uploads/2024/09/contract-signature.jpg?fit=1920%2C1080&ssl=110801920Tom Callawayhttps://lifesciencepartner.com/wp-content/uploads/2024/02/Life-Science-Partner-340-300x138.pngTom Callaway2024-09-23 13:24:542024-10-01 14:01:40How to Find the Right Retained Search Partner (Executive Recruiting Firm)