Full-Time

Senior Director Companion Diagnostics

Precision for Medicine

Precision for Medicine

1,001-5,000 employees

Global CRO for precision medicine trials

Compensation Overview

$203.2k - $304.8k/yr

+ Bonus

Frederick, MD, USA

In Person

PhD

Category
Biology & Biotech (1)
Required Skills
Google Cloud Platform

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Requirements
  • PhD in Immunology or related field
  • 18+ years of relevant experience
  • 12+ years of leadership experience
  • Prior supervisory experience
  • Demonstrated expertise in Companion Diagnostics related to Cell & Gene Therapy regulatory guidance and industry best practice
  • Direct experience and knowledge in cell based assays used for supporting regulated studies
  • Solid understanding of current GLP, GCP or GCLP standards
  • Working knowledge of CAP/CLIA, CLSI and ISO 13485
  • Excellent communication, interpersonal, organizational and multi-tasking skills
  • Proficiency with Microsoft Word, Excel, and PowerPoint
  • Ability to interact and function in a highly productive work environment
  • Ability to work independently and have good attention to detail
  • Must be able to read, write, speak fluently and comprehend the English language
Responsibilities
  • Mentor and lead all companion diagnostic teams to ensure high quality compliant data
  • Works with Lab Director to identify and provide continuing education to laboratory testing personnel that is relevant to laboratory practices
  • Direct staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects
  • Monitors and provides metrics, KPIs to senior leadership which includes but is not limited to: quality metrics, TAT, assay failure rate, volumes and revenue
  • Monitors inventory (client and precision inventory) and lab supplies; ensures staff perform regular inventory counts and updates the inventory software system
  • Ensure lab is run efficiently, reviews processes, SOPs and implements improvements regarding operational excellence
  • Is main contact for clients regarding scientific updates and manage client expectations for all projects within the team. Provides verbal or written updates as necessary
  • Participate actively in the companion diagnostics community to ensure Precision is fully aware of any and all relevant guidance with the Cell & Gene Therapy Industry
  • Participate in product (device) development, commercialization and life cycle management
  • Have good working knowledge of execution of assay according to ISO 13485 Design Control procedures, ISO 15189 Medical Laboratories as well as knowledge of CLIA and CLSI requirements for assay validation. Coordination of cross functional activities between Precision business units and among various subject matter experts to increase operational efficiencies and streamline deliverables to clients
  • Review and approve development and validation study protocols and reports to meet CAP/CLIA and CLSI requirements
  • Oversee the execution of all work to ensure the team understands and is meeting study compliance for all work performed, including study budget requirements
  • Responsible for trouble shooting and correcting all scientific issues/problems within the team
  • Prepare/review/writes critical documents including protocols, reports, and SOPs
  • Work collaboratively with other technical teams in resource sharing and providing technical expertise
  • Maintain and support safe lab practices and environment
  • Carry out other duties/projects as assigned
Desired Qualifications
  • Direct experience working at a CRO, Biotechnology or Pharmaceutical company
  • Expertise in ELISA, MSD, Luminex, Quanterix and SPR technologies
Precision for Medicine

Precision for Medicine

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Precision For Medicine is a global clinical research organization (CRO) that helps life sciences companies run clinical trials from early to regulatory approval. It specializes in precision medicine, focusing on oncology, cell and gene therapy, and rare diseases. The company combines clinical trial services with specialty laboratory work and data sciences to improve speed, reduce costs, and increase the likelihood of success in bringing therapies to patients. It differentiates itself by integrating advanced technologies and data-driven biostatistics with specialized labs to support end-to-end trials across all stages. Its goal is to enable faster, more cost-efficient development of targeted therapies that meet regulatory requirements and reach patients in need.

Company Size

1,001-5,000

Company Stage

Growth Equity (Venture Capital)

Total Funding

$225M

Headquarters

Chevy Chase, Maryland

Founded

2012

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Simplify Jobs

Simplify's Take

What believers are saying

  • Amanda Owens joined August 2026 to scale high-demand biospecimen solutions.
  • Chris Clendening joined to push AI-driven specialty labs and biomarker workflows.
  • Japan office and Singapore office expand access to Asia-Pacific trials and patients.

What critics are saying

  • Blackstone is shopping Precision Medicine Group CRO assets in 2026, disrupting retention.
  • S&P kept Precision at B- in August 2025, signaling heavy sponsor leverage.
  • Trade-secret litigation with Blue Matter persists through March 2026, draining management attention.

What makes Precision for Medicine unique

  • Triple former FDA oncology leaders give Precision rare regulatory muscle.
  • Tokyo and Singapore offices deepen APAC trial execution in regulated markets.
  • Biospecimen biobanks with 10 million specimens anchor integrated lab-clinical services.

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Benefits

Health Insurance

Life Insurance

Disability Insurance

Parental Leave

Paid Sick Leave

Paid Vacation

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

1%

2 year growth

6%
PR Newswire
Aug 20th, 2026
Amanda Owens joins Precision for Medicine to expand biospecimen access for drug research

Precision for Medicine has appointed Amanda Owens as General Manager, Biospecimen Solutions. She will lead the business's commercial and operational strategy as demand grows for deeply annotated biospecimens rich in genetic and molecular data. Owens brings extensive life sciences experience across biospecimen services, genomics, gene editing and advanced therapies. She previously held senior commercial leadership roles at Landmark Bio and Discovery Life Sciences. Precision for Medicine maintains biorepositories containing over one million biofluid specimens and three million tissue specimens. The company integrates clinical trial design and execution with laboratory expertise and data intelligence. Owens holds an MBA from the University of Alabama in Huntsville and advanced degrees in biological sciences. She is based in Nashville, Tennessee.

Investors Hangout
Aug 20th, 2026
Amanda Owens leads Precision Medicine's biospecimen expansion.

Amanda Owens leads Precision Medicine's biospecimen expansion. Shaking up the biospecimen game. Amanda Owens, a seasoned pro in the life sciences sector, is now in the driver's seat at Precision for Medicine, taking charge as General Manager of Biospecimen Solutions. This ain't just a fancy title; she's stepping into a role that's shaking up how biopharma taps into biospecimens for drug development. It's a bustling field, folks, because the demands are soaring - everyone wants more data, more accuracy, and more bang for their buck in research. The new frontier in drug development. What's the big fuss about biospecimens, you ask? Well, they're not your average samples snagged off a shelf. Investors Hangout, LLC is talking about specimens that pack a punch with genetic and molecular profiles, the very things pushing forward next-gen therapies. This is a scientific gold rush, and Owens is the guide who knows where to dig. Her track record spans from landmark roles at Discovery Life Sciences to steering commercial ships at Landmark Bio. If there's one thing this industry needs, it's someone who knows how to marry science with strategy - precisely what Owens brings to the table. Unpacking the leadship strategy. Owens steers toward strategic partnerships. If you think it's all about the samples, think again. Sofia Baig, the president over at Precision for Medicine, made it clear: matching the right sample to the right project is an art, not a mere transaction. That means diving deep into what the sponsors need and predicting how those needs morph over time. Precision has these massive stash houses of over a million biofluid specimens and three million tissue samples, so Owens gets to play with a helluva repertoire. "Quality and speed are not negotiable. It's about a comprehensive understanding," said Owens, emphasizing the teardown of transactional barriers. Consultative partnerships over transactions. This isn't just delivering goods. Precision's suite of lab capabilities enables them to dig plenty deeper than the surface level, crafting partnerships instead of simple hand-offs. It's a pivot toward consultative relationships rather than mere supplier-buyer exchanges. This is where the biz smarts meet scientific vigor, and Owens is poised to harness those dual strengths. The broader impact. Why investors should take notice. Here's the investor angle: what Owens' appointment means for the sector is a steady trajectory towards more integrated, technically sophisticated biospecimen solutions. It's a nod toward adding value in the pipeline - accelerating drug discovery translates into quicker revenue streams and perhaps lucrative partnerships or buyouts down the road. Stay tuned to the playbook Owens rolls out because it could be a game-changer in how the industry views biospecimen sourcing. Precision for Medicine's backing, with over 3,500 people spread internationally, serves as both an engine and a shield. Whether you're looking from the perspective of a startup in biotech or a solid player in pharma, these are the kinds of developments that shape strategic pivots and can push market momentum. Play your cards right, and Owens' blueprint might just become the one everyone else tries to imitate. Investors ought to watch how this strategic rolodex grows under her leadership.

PR Newswire
Jul 14th, 2026
Laboratory veteran Chris Clendening joins Precision for Medicine to lead global specialty labs

Precision for Medicine has appointed laboratory industry veteran Chris Clendening as General Manager, Labs Translational Sciences. Reporting to President Sofia Baig, Clendening will oversee Precision's global specialty labs business, including operational delivery, growth strategy, and AI-driven approaches to accelerate biomarker research. Clendening most recently served as Senior Vice President of Biotechnology Operations and Product Development at Clario. He previously spent over a decade in executive leadership at PPD Central Labs, where he developed an evolutionary central laboratory platform that earned him the CenterWatch Award for Innovation. In his new role, Clendening will focus on global operational delivery and developing integrated scientific solutions for Precision's clients worldwide. He holds a Bachelor of Science in biology and chemistry from Muskingum University and is based in Cincinnati, Ohio.

PR Newswire
May 21st, 2026
Former FDA oncology leader Paz Vellanki joins Precision for Medicine as third ex-regulator on team

Precision for Medicine has appointed Paz Vellanki, MD, PhD, as Vice President of Clinical Development, Oncology. Dr Vellanki previously served as Associate Director of the Division of Oncology 2 at the FDA, overseeing drug development for lung cancer, head and neck cancer and rare tumours. Her appointment completes a trio of former FDA oncology leaders at the company, joining Chief Medical Officer Harpreet Singh and Vice President Nicholas Richardson. During nearly seven years at the FDA, Dr Vellanki led the technical guidance on circulating tumour DNA for early-stage solid tumours and served on the Project Endpoint Working Group. The biomarker-driven clinical research organisation, part of Precision Medicine Group, operates across 40 locations globally with 3,500 staff.

El Referente
Mar 26th, 2026
RETECH-Madrid Community helps connect innovation with the real needs of the healthcare system.

RETECH-Madrid Community helps connect innovation with the real needs of the healthcare system. We interviewed the co-founders of eB2, best solution in the RETECH-Madrid Community health challenge. eB2 is a health startup that develops tools and solutions for patient care and monitoring using Artificial Intelligence and mobile technologies. eB2 is a platform applied to mental health, certified as a medical device, that allows continuous monitoring of patient behavior and transforms it into objective clinical indicators. The company has been recognized as the best solution for the health challenge defined by the company Precision for Medicine, at the II Innovation Forum of the RETECH-Madrid Community project. The meeting brought together over 50 ecosystem actors including startups, scaleups, and leading companies in Greentech, Health, and Aerospace at the SID building in Tres Cantos, with the aim of fostering business collaboration and addressing the real challenges of these three strategic sectors through technological solutions. We spoke with Ana Hernando Abascal, co-founder and CEO, and Antonio Artés Rodríguez, co-founder and CSO of Evidence-Based Behavior (eB2) about their startup's goals and their experience in the Digital Entrepreneurship Networks project in the Madrid Community. How would you define your solution in the health field and what needs does it address? eB2 (Evidence-Based Behavior) is an artificial intelligence platform applied to mental health, certified as a medical device, that allows continuous monitoring of patient behavior and transforms it into objective clinical indicators. It addresses a key need of the healthcare system: moving from a reactive model, based on occasional visits, to a preventive model capable of early detection of clinical deterioration. Today, professionals lack continuous and objective tools to anticipate relapses or crises. Our solution acts as a clinical co-pilot, helping professionals make more informed decisions and intervene earlier, improving care quality and system efficiency. Additionally, the platform is also used in clinical and academic research, enabling the generation of scientific evidence and development of new digital biomarkers based on longitudinal data. What does it mean for you to have been selected as the winner among the health startups participating in the II Innovation Forum? It is a very important recognition, especially because it comes from the public-private ecosystem and leading companies in the sector. For us, it validates three things: the relevance of the problem we address, the maturity of our solution, and its real applicability in both clinical and research settings. Furthermore, it represents an opportunity to accelerate collaborations with organizations and advance towards broader implementation in the health system. What are your main business objectives in the short and medium term? In the short term, our goal is to consolidate deployments in hospitals and mental health provider centers and expand the use of the platform in different clinical cases, strengthening impact evidence. We also want to continue promoting its use in clinical and academic research, generating new predictive models and scientific evidence. In the medium term, we aim to scale in Europe, advance in certification as a higher-level medical device, and position ourselves as a standard in mental health monitoring and prediction. What learnings would you highlight from your participation in the innovation forum? The main learning has been the importance of the real fit between problem and solution from the perspective of leading companies. The forum allows rapid validation of what is a priority for the healthcare system: integration, scalability, clinical evidence, and real implementation capacity. I would also highlight the value of the open innovation format, which facilitates very concrete conversations aimed at collaboration in both care and research. What do you consider being part of the startup and innovation ecosystem of the Madrid Community has contributed to you? The Madrid Community has a very strong ecosystem in health, research, and technology, and for us it has been key in our development. eB2 was born as a spin-off from Carlos III University of Madrid, and growing within this environment has allowed us to combine high-level research with real clinical application. Being part of this ecosystem has facilitated collaboration with hospitals, research centers, and other key actors, accelerating both development and clinical and scientific validation of the technology. Additionally, initiatives like RETECH-Madrid Community help connect innovation with real needs of the healthcare system, which is essential for bringing solutions like ours to market. Looking ahead, what milestones or key developments do you expect to achieve? Our next milestones are focused on three areas: First, expanding deployments in health systems and demonstrating impact at large scale. Second, advancing regulatory certification and clinical validation in new use cases. And third, continuing to develop artificial intelligence capabilities and evidence generation through clinical research. Our goal is to contribute to a paradigm shift: a more preventive, personalized, and data-driven mental health. Digital Entrepreneurship Networks. Digital Entrepreneurship Networks in the Madrid Community is a project led by the Madrid Community, through the Ministry of Digitalization, within the framework of the RETECH project (Territorial Networks of Technological Specialization) and funded by European NextGenerationEU funds under the Recovery, Transformation, and Resilience Plan. Investment Guide 2025 National report on tech and innovative companies.