Vice President Regulatory Affairs (Sioux Falls)

The Vice President Regulatory Affairs (RA) is responsible for ensuring that compliance is being upheld for Regulatory Affairs at SAB Biotherapeutics (SAB). This role will lead preparation, review and submission of documents to FDA and ex-US health authorities to support product development of new biologics and regulatory and compliance aspects through the drug product lifecycle. The incumbent must be able to combine knowledge of scientific, regulatory, and business issues to ensure products are developed and manufactured according to regulations related to the manufacturing and distribution of biologics. This position manages and prioritizes RA team work on all required interim and final BLA and MAA submissions. The incumbent will regularly work cross-functionally with Clinical Development/Pharmacovigilance, Manufacturing/CMC, Quality, Medical Affairs and Commercial Readiness teams to ensure regulatory objectives align with corporate strategy and deliverables. Key Responsibilities (include but are not limited to): Provide efficient and effective regulatory representation across the organization and act as the liaison in interactions and communications (meetings, phone calls, etc.) with the Food and Drug Administration (FDA) as needed. Prepare summaries of meetings for inclusion in regulatory archives. Provide guidance for, and actively contribute to, the development of regulatory submissions, which may include Investigational New Drug (INDs) applications, briefing documents, orphan drug applications, breakthrough designations, Emergency Use Authorization requests and Biologics License Applications (BLAs), ensuring that they meet current regulatory requirements and industry standards. Assess acceptability of quality, preclinical and clinical documentation for regulatory submissions. Identify and develop new company regulatory policies, procedures and SOPs and general trainings for Executives and Upper Management and more specific trainings for regulatory staff. Develop regulatory strategy plans with specific deliverables and timelines and integrate business and clinical objectives with regulatory requirements. Manage inspections and audits by regulatory authorities and accompany inspection team(s) as required. Provide input for follow-up to inspections and audits to minimize potential findings of non-compliance. Oversee labeling, advertising, and promotional material review to ensure regulatory compliance. Develop, implement, and manage appropriate SOPs and systems to track and manage product-associated events including reporting of adverse events and providing input for product recalls and recall communications. Review change controls to determine the level of change and consequent regulatory submission requirements. Ensure compliance with all regulatory reporting requirements, including annual and periodic reports and maintain annual licenses, registrations, and listings through active and hands‑on management. Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory impact and risk and identify filing strategies. Regular cross‑functional collaboration to ensure regulatory strategy, filings and compliance activities are aligned with corporate objectives and development timelines. Independently provide phase‑appropriate strategic guidance/input related to current regulatory requirements and expectations for INDs and BLAs for development projects. Provide regulatory leadership for regulatory risk assessments, scenario planning, and decision‑support to guide development strategy, program prioritization, and corporate milestones. Participate in due diligence activities, as required. Partner with the SVP RA/QA to develop and implement the infrastructure needed to grow for Regulatory Affairs and Quality Assurance. Collaborate with Quality Assurance to define, assess, and strengthen process controls across GxP operations, ensuring that manufacturing, testing, and quality system processes meet regulatory expectations and support inspection readiness. Regular travel to SAB location and other sites/locations as needed. Travel to the Sioux Falls facility projected at 1-2 weeks onsite per month initially followed by a regular cadence to the facility as needed. Supervisory Responsibilities This position has supervisory responsibilities. Education/Experience/Skills Bachelors’ degree in scientific field/healthcare/regulatory discipline required. Advanced degree in relevant field is preferred. 15 years of RA roles with increasing responsibility within regulatory affairs at one or more biopharmaceutical/pharmaceutical companies. Must have experience interacting with FDA, EMA, and MHRA. Proven leadership experience in the establishment of INDs and approvals of BLAs. Must have NDA, BLA, and MAA filing and approval experience. Demonstrated knowledge of biologic manufacturing processes, GMP principles, and related FDA and ICH regulatory requirements. Demonstrated experience in chemistry and manufacturing controls (CMC) and clinical issues and filings. Management expertise and proven experience leading and developing high performance teams. Ability to work effectively across teams, functions and with outside partners. Familiar with US and International regulatory markets. A strong team player with a passion for science and helping discover and develop novel therapies for unmet medical needs. Excellent written and verbal communication skills. Must be proficient in Microsoft Office software (Word, Excel, PowerPoint, and Outlook). Ability to effectively present information in one‑on‑one, small groups and lab meetings. Physical Demands While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must regularly lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus. Working Environment and Travel Normal home office environment as well as on‑site in SAB office location in Sioux Falls, SD. Regular travel to SAB location and other sites/locations as needed. Travel to the Sioux Falls facility projected at 1-2 weeks onsite per month initially followed by a regular cadence to the facility as needed. ADA The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non‑disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets J-18808-Ljbffr

Regional Director, Sales (Arlington)

Regional Director, Law Firms, Small and NationalApplylocations: Arlington, VA - 1801 S Bell (INDG)time type: Full timeposted on: Posted Yesterdayjob requisition id: 142949You are responsible for managing, coaching, and directing a team of sales and service professionals in one of four enterprise regions. You will work with your team to manage full renewal and new sales cycles in order achieve business, sales, and renewal goals working with clients primarily in the AmLaw 200 Law firm market. You will be a critical member of our Law Firm leadership team contributing and helping to shape our overall team strategy What You Will Do : * Achieve revenue and retention goals associated with your region.* Create and execute growth and retention strategies for your region, ensuring a sales and service process rigor.* Drive collaboration within your team, ensuring they work together to achieve success by creating strong engagement/adoption strategies, minimizing downgrades, and maximizing “land and expand” upsell strategies.* Drive a client first mentality within the organization.* Hire, coach, develop and mentor a strong team, including spending time in the field with sales and service reps.* Develop relationships with key stakeholders with current and prospective clients as well as gaining insights into their business and related needs.* Provide weekly forecasting for sales and renewals as well as sales pipeline analysis.* Participate in special projects beyond region to benefit Law Firm/Law School team.* Job Requirements : Proven experience with full customer lifecycle - strategic selling knowledge, sales methodology, process. Ability to write a business plan. Business mindset Clients-First mindset. Strong communication skills. Strategic thinking ability. Ability to take accountability for driving a successful team. Ability to drives Bloomberg Industry Group Values. Proven ability to inspire and motivates a team. Excellent collaboration and interpersonal skills. Ability to nurture and develop talent. Ability to use office productivity tools and technology in use at our organization. Ability to travel out of town on a frequent basis. Education and Experience : Bachelor’s degree with coursework in business, marketing, sales, related field, or equivalent experience. Minimum 5 years of successful sales experience, preferably in the legal/tax information industry, electronic information industry, or with Bloomberg Industry Group. Minimum 3 Years of Sales Management experience, preferably in the legal/tax information industry, electronic information industry, or with Bloomberg Industry Group. Compensation Range: $135,000.00-$175,000.00 Placement in the salary range will be decided upon completion of the interview process. Salary determination will be determined based on factors including but not limited to relevant experience, demonstrated skills related to the requirements of the role, education, certifications, and geographic location. Equal Opportunity Bloomberg Industry Group maintains a continuing policy of non-discrimination in employment. It is Bloomberg Industry Group’s policy to provide equal opportunity and access for all persons, and the Company is committed to attracting, retaining, developing, and promoting the most qualified individuals without regard to age, ancestry, color, gender identity or expression, genetic predisposition or carrier status, marital status, national or ethnic origin, race, religion or belief, sex, sexual orientation, sexual and other reproductive health decisions, parental or caring status, physical or mental disability, pregnancy or maternity/parental leave, protected veteran status, status as a victim of domestic violence, or any other classification protected by applicable law (“Protected Characteristic”). Bloomberg prohibits treating applicants or employees less favorably in connection with the terms and conditions of employment, in all phases of the employment process, because of one or more Protected Characteristics (“Discrimination”). J-18808-Ljbffr

Neurosurgery APP (NP/PA) - Burlington (Burlington)

When you join the growing BILH team, you’re not just taking a job, you’re making a difference in people’s lives. Job Description Lahey Neurosurgery: APP Opportunity (NP/PA) Join our dynamic team as a skilled PA/NP for inpatient neurosurgery care. Your Role Pre/post‑op patient management. Daily inpatient service & emergency response. Assist in advanced neurosurgical procedures. Patient/family education. Utilize advanced imaging. Why Lahey? Collaborate with top neurosurgeons. Career growth & training. State‑of‑the‑art facility. Flexible shift coverage. Competitive salary based on experience Comprehensive benefits package Free, on‑site parking Requirements Neurosurgery/related experience (preferred). Strong clinical & communication skills. Team player & autonomous worker. Epic/Microsoft proficiency. License/Certifications MA APP license. Graduate of an accredited PA or NP program (AGACNP or ACNP only MA prescriptive authority & DEA. Beth Israel Lahey Health, including all of its employing entities, are a purpose‑driven, values‑based organization that unites our workforce of people who provide exceptional health care to everyone we serve. All of the employing entities of Beth Israel Lahey Health maintain policies of equal employment opportunity and non‑discrimination in employment. Please see here for more information about our purpose and values (https://bilh.org/about/purpose-values) and here for more information about our Equal Employment Opportunity Policy (https://bilh.org/careers/eeo-policy). Pay Range $133,120.00 USD – $215,000.00 USD. The pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) as a condition of employment. More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients’ lives. Your skill and compassion can make us even stronger. Equal Opportunity Employer/Veterans/Disabled J-18808-Ljbffr

Director, Product Management - Connectivity-Led Experiences (Hybrid - Oak Brook, IL) (Oak Brook)

Director, Product Management - Connectivity-Led ExperiencesSkip to main contentBy clicking Accept Cookies” or continuing to browse our website, you agree to the use and storing of cookies on your device. We use cookies to offer you a better experience, analyze website usage, and serve targeted advertisements. You can manage your cookies settings by selecting Cookie Preferences. To learn more, view our Privacy Policy: https://chamberlaingroup.com/privacy-policy/ CareersDirector, Product Management - Connectivity-Led Experiences page is loaded Director, Product Management - Connectivity-Led ExperiencesApplylocations: Oak Brook, ILtime type: Full timeposted on: Posted 2 Days Agojob requisition id: JR31112Chamberlain Group (CG) is a global leader in intelligent access and Blackstone portfolio company. Powered by our myQ technology, we make access simple and secure for millions of homeowners, businesses, and communities worldwide. Our flagship brands, LiftMaster and Chamberlain , are found in 51 million homes, and 14 million people rely on the myQ app daily.* Develop, evangelize and execute the connectivity-led experiences strategy for the Chamberlain Group product portfolio, aligned to our broader business objectives — driving profitable growth for Core Products by building deeper affinity with channel partners and increasing attach of service-revenue-generating products to consumers* Shape what “connected” means for Chamberlain — the principles, the platform decisions, the partnership posture, and the experience standards every product delivers* Make ease of use measurable. Define and instrument the metrics that tell us, honestly, whether each release is making the experience simpler for consumers, technicians, dealers and distributors* Own the end-to-end product surface — hardware design choices, cloud platform capabilities, dealer and technician tools, and the services — and bring them together as one experience* Set a 3-year vision for the role of connectivity across the portfolio and the broader myQ ecosystem* Engage regularly with homeowners, dealers, technicians and distributors — through ride-alongs, field visits, advisory boards and trade events — and translate what you learn into clear product priorities* Partner with sales and channel leadership to design dealer programs, training, tooling and merchandising that make the connected portfolio easy to sell, install and service profitably* Lead and grow a team of Product Managers; set the bar for product rigor, customer obsession and cross-functional discipline* Run roadmap governance across multiple workstreams; oversee backlog prioritization, release sequencing and stage-gate decisions across hardware, firmware, cloud and app* Drive cross-functional alignment across Engineering, Product Design, Sales, Channel, Marketing, Customer Care, Supply Chain and Operations* Advise senior leaders on adjacent moves: M&A, licensing, ecosystem partnerships and other inorganic levers that accelerate the strategy.* Represent Chamberlain Group externally with major channel partners, OEM partners, industry associations and trade press.* Comply with health and safety guidelines and rules; managers should also ensure compliance across their teams.* Protect Chamberlain Group’s reputation by keeping information confidential.* Maintain professional and technical knowledge by attending educational workshops, reading professional publications, establishing personal networks, and participating in professional societies.* Contribute to the team effort by accomplishing related results and participating on projects as needed. Education/Certifications: * Bachelor's Degree in Business, Marketing, Computer Science, Engineering or related field Experience: * 8-10 years in Engineering, Marketing and/or Product Management; experience managing product portfolio with multiple categories Knowledge, Skills, and Abilities: * Ability to work in Matrix and Agile software development environment* Understand and have experience with Agile Scrum methodologies or other commonly used tools Other: * Able to travel up to 25% - domestically and internationally Preferred Qualifications Education/Certifications: * Master's in Business Administration Experience: * Prior experience managing hardware and software offerings; experience with P&L management* Experience withVoice of Customer program* Experience with End-to-end ownership of at least one connected product* Built or upgraded PM team Knowledge, Skills, and Abilities: * Comfortable interacting with highly technical development teamsThe pay range for this position is $167,500.00 - $269,875.00; base pay offered may vary depending on a number of factors including, but not limited to, the position offered, location, education, training, and/or experience. In addition to base pay, also offered is a comprehensive benefits package and 401k contribution (all benefits are subject to eligibility requirements). This position is eligible for participation in a short-term incentive plan subject to the terms of the applicable plans and policies.Chamberlain Group wants all of its employees to succeed and encourages people of all backgrounds to apply. We’re proud to be an Equal Opportunity Employer, and you’ll be considered for this role regardless of race, color, religion, sex, national origin, age, sexual orientation, ancestry; marital, disabled or veteran status. We’re committed to fostering an environment where people of all lived experiences feel welcome.Persons with disabilities who anticipate needing accommodations for any part of the application process may contact, in confidence [email protected]. J-18808-Ljbffr

Director Product Marketing (El Segundo)

Key Responsibilities Analyze the market to gain an extensive understanding of the business environment and drive competitor analyses within the AI/Datacenter/Server application spaces Engaged and build relationships with key customers Drive, define and ensure execution of the future product roadmap based on market trends and strategic importance of products Develop business cases for new products that are synchronized with Infineon vision and market needs. Act as project owner for R&D projects, steer the organization and orchestrate marketing efforts and deliverables (business case development, requirements gathering) during the development milestone process Develop comprehensive pricing strategy to ensure maximum profitability and scaling of existing business. Ability to create technical Features Requirement List (FRL) and communicate with R&D team to define hardware and firmware solutions, with clear value propositions for our protection solutions Keep track of running projects and constantly update customers on progress Intensively collaborate with Sales, Application Marketing, Technical Marketing, R&D, Quality, Operations, among other functions Collaborate with Sales, application marketing and R&D to synthesize market requirements into development of a winning/leading product roadmap Manage and develop a business strategy for the product portfolio to ensure the best positioning in the marketplace, drive revenue growth and increase profitability Influence profit/loss of the product segment/portfolio and oversee the Budget assigned to that product group. Deliver product launches and training to a wide internal and external audiences Represent the Product Line to internal and external partners worldwide Qualifications A university degree in electrical engineering, microelectronics with a strong familiarity of the semiconductor market and understanding of power systems. 8 years of experience in product development, product marketing or application engineering related tasks with a strong emphasis on roadmap execution, winning projects and driving revenue Knowledge of Computing / AI Power architectures, relevant products, value chain and customer base preferred. Knowledge of protection solutions, Hot-swap, eFuses, OR-ing and redundant power supplies preferred. Prior knowledge of AI/Server/Telecom related products and their applications is a strong plus Strong team player with high energy level and international networking skills Strong ability to communicate effectively and across functional and hierarchical boundaries and experience in operating in a highly matrixed organization. Possess excellent presentation skills & communication with senior management Willingness to travel Fluent English skills Compensation El Segundo, CA & Austin, TX Minimum of $182,300 salary per year / Maximum of $250,700 salary per year In addition, all employees will be eligible to participate in an incentive plan. Equal Opportunity Employer Infineon Technologies Americas Corp., is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, national origin, ancestry, citizenship, age, physical or mental disability, legally protected medical condition, family care status, military or veteran status, marital status, domestic partner status, sexual orientation, or any other basis protected by local, state, or federal laws. J-18808-Ljbffr

Principal Data Scientist (Austin)

The Principal Data Scientist is a senior leader and technical authority responsible for advancing Central Health System’s data science capabilities in support of population health, care management, and organizational decisionmaking. Operating under the general guidance of the VP of Data Insights & Innovation, this role leads and manages the organization’s Data Science team while serving as the primary data science authority within the organization, providing expert guidance on scientific rigor, validity, and equity of analytical and AI solutions. Working in close partnership with the Sr. Director of AI & Digital Innovation, the Principal Data Scientist provides critical technical input to the AI governance process, including risk assessments, model validation, efficacy adjudication, and alignment with frameworks such as the NIST AI Risk Management Framework (AI RMF). This role also establishes and enforces data science standards governing data quality, feature engineering, model documentation, and analytical reproducibility, ensuring that all data assets and methodologies used in AI and advanced analytics meet the organization's scientific and regulatory expectations. While the Sr. Director leads overall AI strategy, implementation and deployment, this role ensures that the underlying data science is sound, reproducible, ethical, and clinically meaningful. This individual will leverage the organization’s enterprise data environment, including Epic (EHR), VBA (TPA), Microsoft Azure (cloud infrastructure), Snowflake (cloud data platform), and numerous other data sources including clinical and business applications and our local health data utility (HDU formerly HIE), to develop and operationalize scalable, high-impact data science solutions. The Principal Data Scientist also serves as a senior technical advisor to Data Analyst teams, helping to oversee advanced analytics and ensuring advanced analytical deliverables meet the standards required to drive actionable insights across the organization. This position is considered Hybrid. Individuals in this position may work both at an approved off-site location and onsite at a primary location or multiple locations based on business needs. Essential Functions Data Science Team Leadership & People Management Lead, manage, and develop a team of data scientists, providing day-to-day supervision, performance management, coaching, and professional growth planning. Set clear team goals, priorities, and performance expectations aligned with organizational objectives, and hold team members accountable for quality, timeliness, and scientific rigor. Recruit, onboard, and retain top data science talent, building a high-performing team with complementary skills across modeling, analytics, and MLOps. Foster a collaborative, inclusive, and psychologically safe team culture that encourages innovation, intellectual curiosity, and continuous improvement. Serve as the organization’s foremost technical expert in applied data science, statistical modeling, and machine learning as they relate to healthcare and population health. Establish and maintain data science standards, methodologies, and best practices for model development, validation, documentation, and lifecycle management across the team. Provide technical mentorship and direction to team members and data analysts, fostering a culture of scientific rigor and continuous learning. Champion reproducible research practices, including version control of models, datasets, and analytical pipelines. Population Health & Care Management Modeling Design, develop, and maintain predictive models and forecasting solutions that directly support population health management, care coordination, and chronic disease management programs. Build and operationalize risk stratification models to identify high-risk patients and populations for proactive intervention by clinical and care management teams. Develop disease progression models, readmission risk models, utilization forecasting, and other advanced analytics that inform care management and resource allocation strategies. Leverage Epic clinical and operational data, including ADT events, clinical documentation, orders, and registry data, as primary source inputs for model development and validation. Partner with the Clinical Informatics team to guide and inform predictive modeling efforts, ensuring models are grounded in clinical workflow context, aligned with care delivery priorities, and practically implementable at the point of care. Collaborate with clinical, population health, and care management stakeholders to translate operational needs into well-defined data science problems with measurable outcomes. Ensure all models are validated for accuracy, reliability, fairness, and clinical relevance before deployment, with ongoing monitoring for model drift and performance degradation. AI Governance & Risk Advisory Partner with the Sr. Director of AI & Digital Innovation to provide expert data science input into the organization’s AI governance processes, policies, and committee structures. Conduct technical evaluations of AI and machine learning tools under consideration for enterprise adoption, assessing scientific validity, algorithmic bias, data quality requirements, and clinical appropriateness. Adjudicate the efficacy of AI solutions by reviewing vendor‑provided evidence, internal pilot results, and published literature to inform go/no‑go recommendations. Apply knowledge of the NIST AI Risk Management Framework (AI RMF) and related frameworks (e.g., ISO/IEC 42001) to assess and document AI risk relative to organizational tolerance and regulatory requirements. Identify and communicate potential risks associated with AI models, including bias, data drift, explainability gaps, and failure modes, ensuring the Sr. Director and governance committees have the scientific context needed for informed decision‑making. Support the development and maintenance of model documentation, including model cards, data lineage, and fairness assessments, ensuring transparency and auditability. Leverage deep data science expertise to actively contribute to the design and development of AI solutions, translating governance insights, model evaluation findings, and clinical data patterns into actionable recommendations that shape how AI tools are built, refined, and validated for use across the organization. Predictive Analytics & Advanced Statistical Analysis Lead the design and execution of advanced analytics projects, including predictive modeling, machine learning, natural language processing (NLP) for clinical text, and time‑series forecasting. Apply sophisticated statistical methods, including survival analysis, mixed‐effects models, Bayesian approaches, and ensemble methods, to complex healthcare data environments. Develop forecasting models to support operational planning, including patient volume projections, staffing optimization, and financial performance indicators. Ensure analyses account for the complexities of healthcare data, including missingness, selection bias, confounding, and longitudinal follow‑up. Translate analytical findings into clear, actionable insights communicated effectively to both technical and non‑technical audiences. Advanced Analytics Oversight & Data Analyst Collaboration Serve as the senior technical reviewer for advanced analytics work produced by Data Analyst teams, ensuring methodological soundness and alignment with organizational standards. Define and maintain the boundary between standard reporting/analytics and advanced data science work, guiding appropriate escalation and consultation. Collaborate with Data Analyst teams to build their statistical and analytical capabilities through mentorship, code reviews, and the development of reusable analytical frameworks and tools. Contribute to the development of a shared analytics environment built on Azure and Snowflake, including reusable data pipelines, feature stores, and model deployment infrastructure, in collaboration with Data Engineering. Data Quality, Governance & Ethics Partner with data governance and data engineering teams to ensure that data assets used for modeling and analytics are accurate, complete, well‑documented, and governed appropriately. Actively identify and mitigate sources of bias in data and models, ensuring that analytical and AI solutions promote health equity and do not exacerbate disparate outcomes. Adhere to all applicable data privacy and security standards (HIPAA, etc.) in the collection, use, and storage of data for analytical purposes. Contribute to the development of the organization’s responsible AI and ethical data use policies, ensuring scientific perspectives are well‑represented. Minimum Education Doctoral or Professional Degree in Statistics, Biostatistics, Data Science, Epidemiology, Public Health Informatics, Computer Science, or related quantitative field. Required Experience 5 years of experience with applied data science, statistical modeling, or quantitative research experience post‑PhD, with increasing responsibility and complexity. 3 years of experience in healthcare, public health, population health, or a similarly regulated and complex data environment. 2 years of demonstrated expertise in building, validating, and monitoring predictive models and machine learning solutions in a production or near‑production environment. 3 years of experience dev