Regional Director Salary in Santa Clara, CA

Director, CMC Regulatory AffairsDirect Hire Fulltime RoleSalary Range: $208,000 - $235,000 per yearLocation: Redwood City, CA - Hybrid RoleJob Summary:The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of pipeline compounds/products.Duties and Responsibilities:Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products.Lead the preparation and maintenance of the CMC/quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met.Work with the corporate regulatory team, CMC SMEs, and CROs to identify regional/country-specific CMC requirements to support global applications and to drive the CMC submission timelines to meet business objectives.Participate in the interactions with FDA and other global regulatory authorities as appropriate.Provide regulatory assessment and guidance on CMC-related change controls, deviations, and investigations throughout the product life cycle.Participate in the regulatory process initiatives and improvement activities.Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders.Requirements and Qualifications:An advanced degree (MSc or PhD) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field is preferred.15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small moleculesExperience leading CMC-related global submissions (IND, IMPD/CTA, NDA, MAA, etc.)Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issuesDemonstrated experience in effective collaboration with internal and external stakeholdersAble to prioritize and manage multiple projects simultaneously in a dynamic company environmentEffective written and verbal communication skills and good interpersonal skillsDesired Skills and ExperienceCMC Regulatory Affairs, oncology, small molecule, drug development, clinical developmentBayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.

WHO ARE WE?We are global leaders in the Data-Centric Security space. Right from protecting nuclear submarine designs to new drug formulations to customer data of Fortune 100 organizations - we guard every kind of confidential information.HOW DO WE DO IT?Seclore's patent-granted, award-winning technology allows users to control how their information is used - even after it is shared with people within or outside the enterprise. This requires stretching the technology boundaries beyond what might seem possible.At Seclore, you get to be part of the front lines - defending today's data against tomorrow's threats. 2Bn Documents | 3.5 Mn Users | 470+ Enterprises | 29 Countries THE ROLEVP ProductExperience: 10+ yrsLocation: USRole reports to : CEOResponsibilities:As the VP Products, you will report to the CEO and help drive the product vision for the company. The product management leader, you will be responsible for defining, communicating and executing on the product strategy for Seclore. This will include:Lead the product management team to define and deliver best-in-class cybersecurity software solutions with a deep understanding of customer needs and preferences, while defining product roadmaps and direction to delight and retain customers.Develop and implement the roadmap for Seclore to continue to be the leader in the Data Centric Security in ever expanding geographical and vertical marketsPlan and communicate the product strategy to the entire stakeholder group in different time horizons i.e. 6 months, 2 years and 5 years.Attract and retain the best talent in the business and mentor each team member to become a leader.Drive the culture of performance, innovation and entrepreneurship across the companyManage active dialogs with external stakeholders and influencers to the product direction i.e. Customers, prospects, competitors, partners, competitors, regulators, and analysts.Collaborate with the Engineering, Marketing and Revenue leaders to drive technology leadership and market perception of Seclore.Manage all elements of user centric product UX and design from conceptualization and field validation to customer adoption.Establish leading indicators of success and also success metrics and track them through the lifecycle of any initiative.Develop, monitor, and manage the development and implementation of annual operating budgets, forecasts, and metrics. Ensure risks are identified and managed and that resources are utilized judiciously.Work with the marketing team in product launches and other product marketing initiatives.Celebrate individual, team and company successes and acknowledge failures early and gracefully.Skills & Experience that we value:A short list of skills, traits and experiences that you bring are listed below. We understand that there is never a perfect fit here...demonstrated experience of product leadership in an enterprise software / SaaS company ideally in cybersecurityin growth companies in the $10M to $100M revenue ranges since this stage presents unique challenges for product leadership..experience in managing product teams across geographies in North America, Asia and Europewith engineering teams in different time zones requiring appreciation of diverse culturesteams and setting up systems and processes to deliver outcomes to customers.portfolio showcases successful projects and valuable lessons learned from less successful endeavors. You have experience guiding design, product management, product operations and content teams. Your collaborative spirit shines in coordinating the efforts of diverse, cross-functional, multi-disciplinary teams, expertly managing conflicting demands for time and resources.bring M&A experience of identifying targets, conducting product and technology due diligence, supporting the investment thesis and product lines and capabilities.in working with PE/VC investor base and leveraging their expertise and connections.experience throughout the entire product lifecycle, from conception through launch to continuous improvement while ensuring that growth investments are aligned to sales strategy.written and verbal communication skills, with an enthusiasm for engaging a variety of audiences, including clients, partners, and investors.understanding of cybersecurity principles, threats, and industry best practices.knowledge of cloud-native technologies, architectures, and service delivery modelsskill of setting up success metrics and early indicators for failure within the product management teamto travel extensively across the world to meet internal and external stakeholders.Note: Kindly reach out on [email protected]

NVIDIA has been redefining computer graphics, PC gaming, and accelerated computing for more than 25 years. Today, we're tapping into the potential of AI and Omniverse to define the next era of computing. An era in which our platforms act as the brains of computers, robots, and self-driving cars that can understand the world. The Auto BD team is looking for a high-impact, well-rounded leader who thinks strategically, and is hands on with leading complex global sales / channel opportunities. Prior experience in global, cross-functional, matrixed and collaborative environments will be valuable in this role.The NVIDIA Auto BD leader for Cloud partners will build programs and implement sales strategies that grow NVIDIA's business with our Cloud Service Provider (CSP) partners. In this role, you will partner with NVIDIA's co-sell account manager and CSP partner business manager(s) to operationalize and mature the co-sell partnership. Success will be measured by the growth of NVIDIA's influence and direct revenue on the cloud. We seek a high-energy sales channel professional to enable CSP account teams to sell NVIDIA solutions in the cloud. It is an exciting opportunity to be a leader with a vision in AI, building a go-to-market motion with our CSPs, and growing NVIDIA's cloud business!What you'll be doing:Work closely with CSP partner business manager(s) to build and operationalize a partnership plan, with success metrics, that drive engagement on deal registration, pipeline management, and global alignmentDesign NVIDIA into CSP co-sell programs to enhance partner focus and benefitCollaborating with NVIDIA sales operations and account teams to align and run CSP's co-sell deal registrationCollaborate closely with the CSP marketplace(s) and NVIDIA teams to promote solutions (private offers, etc.) that generate growth and scale NVIDIA cloud solutions - most importantly DGX Cloud for AI and Omniverse Cloud for Digital TwinsCreate sales plays with corresponding incentive programs to engage CSP sellers to position NVIDIA solutions and activate lighthouse customers to broaden market reach.Continuously enable NVIDIA sellers on the CSP partner strategy, co-selling motion, and the better together value proposition; Empower the field and partners with comprehensive knowledge of NVIDIA products, its unique value proposition, and its competitive positioning.Partner with the regional sales team to establish a robust monthly forecast and 4 quarter pipelineCollaborate with CSP, GSI/SDP and Agency partners to help close and deliver on jointly developed pipelineShape the Automotive growth strategy, working with the Automotive Enterprise BD leadership team and collaborate with Automotive Embedded BD leadersWhat we need to see:BA degree or equivalent experience10+ years of proven success with partner alliance management, ideally experience working directly with cloud service providersSpecific experience and relationships with Cloud Service Providers (ideally experience working at or selling to/with major cloud providers)A passion for getting things done in a sales and technology environmentDemonstrated ability to provide thought leadership, think strategically, and effectively communicate vision (both written and verbal)Understanding of data science workflows, machine learning, and AI trendsA strong interest in understanding new technologies and adept at conveying their value to business executives and software development leadersProven track record working in a matrix-managed team. Shown ability to collaborate and influence cross-functional teams without formal authority with external partners and internal cross-functional teams at all levels.Ways to stand out from the crowd:Excellent interpersonal skills and ability to persuade -- using simple communication that conveys sophisticated concepts in a compelling, concise, and creative way.Experience working with ISVs and Global System Integrators (GSIs) to accelerate solution deployment.Master's degree (or equivalent experience) in Business or Engineering is a plusNVIDIA is widely considered to be one of the technology world's most desirable employers. We have some of the most forward-thinking and hardworking people in the world working for us. If you're creative and autonomous, we want to hear from you!The cash compensation range is 196,000 USD - 345,000 USD, with 85% paid through base salary and 15% variable compensation. Your cash compensation will be determined based on your location, experience and the pay of employees in similar positions.You will also be eligible for equity and benefits. NVIDIA accepts applications on an ongoing basis. NVIDIA is committed to fostering a diverse work environment and proud to be an equal opportunity employer. As we highly value diversity in our current and future employees, we do not discriminate (including in our hiring and promotion practices) on the basis of race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status or any other characteristic protected by law.

Full job descriptionOpportunity:Vice President of ManufacturingJob Summary:Are you ready for your next challenge? If so, the family office owner of this dynamic company is seeking an experienced, highly technical, Vice President of Manufacturing who is a very 'hands-on' leader to assume the day-to-day operations with full P & L responsibility.The company, located in the Bay Area / Silicon Valley, is a small, high-growth business employing approximately 30+ individuals. The organization provides mission critical manufacturing, assembly and design services to customers in the semi-conductor, biotech, environmental and other industries.The role will be responsible for overall strategy and day-to-day management and leadership of all manufacturing operations, including overseeing engineering and manufacturing processes to ensure on-time delivery of our products, best-in-class quality, and controlling of costs. This position will engage, lead, train, and mentor others within the overall manufacturing operations to achieve best practices that drive improvements in our business. The position requires a leader capable of facilitating and driving change in a fast-paced environment, knowledge and understanding of lean manufacturing principles, the fundamentals of product, processes, manufacturing, engineering, and quality assurance.The successful candidate will be intellectually curious and have an entrepreneurial spirit backed with an extensive background in small company marketing, engineering, manufacturing, and financial practices and procedures. A hands-on management style and mechanical inclination are prerequisites. Successful performance in this position will lead to promotion to President after a 6-12 month transition period, as well as other growth opportunities within the family office portfolio, including transferring to a leadership position in other owned businesses across various industries and geographies if desired. Job Type: Full-timePay: $250,000.00 per year + annual performance bonusResponsibilities:Hands-on day-to-day management and execution of manufacturing operations.Work closely with the family office CFO to ascertain performance and establish company-wide budgets for required operating needs and capital expenditures.Lead the team in setting the strategic direction of the business using short and long term financial and operational goals, and facilitate and implement specific initiatives to support that strategic plan / company direction. Enable strategic vision through the development of process designs and requirements needed to ensure success for operations and customer support.Develop and maintain key supplier and customer relationships.Develop and implement manufacturing-wide lean manufacturing practices and cost reduction activities.Develop, approve, and present operational key performance indicators (KPIs).Oversee maintenance of all machinery and equipment.Analyze processes for sub-optimal performance, collect data, communicate findings, and effectively make recommendations for improvement.Oversee capacity planning and facility layout in support of day-to-day production and alignment with continued business growth. Develop and manage production schedules, capacity parameters, and labor adjustments to align with order demands.Responsible for directing the selection and training of personnel and overseeing performance management for subordinates. Drive accountability while empowering individuals to assume greater levels of responsibility and personal contribution. Develop and maintain a highly motivated and enthusiastic workforce in the development and implementation of programs that will attract, retain, and motivate employees.Lead reduction of waste in processes (scrap, rework, attrition)Ensure a healthy and safe working environment, and compliance with federal and state regulations, through collaboration with outside counsel.Background:Educational requirements are an engineering degree, preferably accompanied by an MBA and/or equivalent experience.Experience in the semiconductor industry required.8+ years in a manufacturing environment.Extensive knowledge and experience in manufacturing and process improvement/optimizations.Demonstrated background in sales and marketing.Strong leadership & problem-solving skills with innovative solutions and creativity in a fast-paced environment.Demonstrated strong organizational, collaboration, project management, and communication skills.Proven ability to work under pressure, organize, plan, manage, and prioritize multiple deliverables.Excellent lean manufacturing and quality assurance methodologies knowledge.Proficient in Microsoft Suite and experience with ERP and CRM systems.Working Conditions & Physical Requirements:Prolonged periods sitting at a desk and working on a computer on occasion.Must be able to lift up to 30 pounds at times.Must be able to quickly traverse manufacturing areas.Must be able to stand, bend, crawl, stretch, lay, and squat in order to maintain/inspect equipment.Benefits:401(k)Dental insuranceHealth insurancePaid time offTuition reimbursementVision insuranceWork Location: In personWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.