<p> </p><p><strong>Position Summary:</strong></p><p>The Executive Director / Site Head of Precision for Medicine<strong> (located onsite in Frederick, MD)</strong> will be responsible to oversee the laboratory operations across 3 different functional groups in Frederick, Maryland. This role is responsible for ensuring that lab environments, processes, and systems are optimized to enable scientific and operational excellence while maintain regulatory compliance. A critical requirement is deep current knowledge of FDA guidance documents and requirements, along with the ability to put these requirements into practice developing robust assays that easily pass FDA scrutiny. Experience with developing and managing programs following FDA/IVDR,. ISO 13485 and 15189 principles of design control, understanding of both CLIA and CLSI validation requirements, and assay execution of both cell-based and non-cell-based assays is required. </p><p><strong>Essential functions of the job include but are not limited to: </strong></p><ul><li>Full responsibility of operational aspects for all laboratories in Frederick MD; including Bioanalysis, Flow Cytometry and Companion Diagnostic.</li><li>Support, hire, coach and mentor laboratory lab heads in Bioanalytical, Flow and CDx</li><li>Collaborate with site supporting departments: Facilities, Biorepository, Quality Assurance, Finance, as well as other global site heads.</li><li>Monitor and report site KPIs including quality events, turnaround time, capacity, revenue delivery and budget adherence.</li><li>Is fully responsible for improving operations and enhancing operational excellence in each laboratory.</li><li>Responsible for weekly and monthly revenue reporting, cost tracking and margin expansion.</li><li>Provide operational excellence leadership ensuring that the team is efficient and has appropriate resourcing.</li><li>Mentor and lead laboratory head for all applicable laboratories.</li><li>Direct staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects</li><li>Ensure all work is completed to the appropriate regulatory guidelines, CAP/ CLIA/ GxP.. etc..</li><li>Work closely with QA and our regulatory team to ensure compliance to industry standards.</li><li>Attend and actively participate in FDA calls regarding assay development and compliance.</li><li>Ensures all development and validation study protocols and reports meet CAP/CLIA and CLSI requirements</li><li>Establish and implement a communication strategy to ensure timely and consistent dissemination of information to engage key stakeholders across the site and within Precision.</li><li>Communicate clearly with clients and manage client expectations for all projects within the teams</li><li>Is responsible for establishing best practices for company business operations processes and systems to support growth and efficiencies.</li><li>Prepare/review critical documents including protocols, reports, and SOPs as applicable: Oversee the establishing and improving of all procedures and required SOP documentation</li><li>Oversee the team in relation to trouble shooting and correcting all scientific issues/problems within the teams</li><li>Support all leaders in the review of data and provide written and verbal technical updates to clients as needed; be an escalation point for clients.</li><li>Work collaboratively with other technical teams in resource sharing and providing technical expertise</li><li>Act as a scientific resource externally to clients and internally on Product and Services/ R&D related projects</li><li>Assist with writing, reviewing and editing contracts and scope of works, change orders.</li><li>Maintain and support safe lab practices and environment</li><li>Carry out other duties/projects as assigned</li></ul><p><strong>Qualifications:</strong></p><p>Minimum Required</p><p></p><ul><li>PhD in Immunology or related field</li><li>20+ years’ relevant experience</li><li>15+ year leadership experience</li></ul><p></p><p>Other Required:</p><ul><li>Prior supervisory experience</li><li><strong>Direct working experience and knowledge in cell based assays / bioanalysis of large or small molecule used for supporting clinical studies</strong></li><li>A solid understanding of current GLP, GCP or GCLP standards</li><li>Working knowledge of CAP/CLIA, CLSI and ISO 13485</li><li>Experience hosting and participating in regulatory audits</li><li>Excellent communication, interpersonal, organizational and multi-tasking skills</li><li>Must be proficient with Microsoft Word, Excel, and PowerPoint</li><li>Ability to interact and function in a highly productive work environment</li><li>Ability to work independently and have good attention to detail</li><li>Must be able to read, write, speak fluently and comprehend the English language</li></ul><p>Preferred:</p><ul><li>Direct experience working at a CRO, Biotechnology or Pharmaceutical company.</li><li>Expertise across multiple technology platforms, including ECL, ligand-binding assays (LBA). Cell-based plate assays, flow cytometry and enzymatic activity assays,</li></ul><p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="description">Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.</div><div class="title">Reasonable estimate of the current range</div><div class="pay-range"><span>$203,200</span><span class="divider">—</span><span>$304,800 USD</span></div></div></div><div class="content-conclusion"><hr><p>Any data provided as a part of this application will be stored in accordance with our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&reserved=0">Privacy Policy.</a> For CA applicants, please also refer to our <a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&reserved=0">CA Privacy Notice</a>.</p><p>Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.</p><p>If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at <a href="mailto:myHR@precisionmedicinegrp.com">myHR@precisionmedicinegrp.com</a>.</p><p><span data-teams="true"><strong>Recruitment Fraud Warning: </strong>Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at <a id="menur2oq" class="fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn" href="mailto:myHR@precisionmedicinegrp.com" target="_blank">myHR@precisionmedicinegrp.com</a> so we can investigate and take appropriate action.</span></p></div>