Job Closed

This listing is no longer active.

Entersekt

Entersekt is a leader in digital banking fraud prevention and payment security, including mobile authentication, mobile app security, and 3-D Secure authentication for issuers, acquirers, and payment networks. Founded over 16 years ago. Protects the digital transactions of over 210 million active users. Holds 120 active patents in digital security, payments, and user experience. Focus on North America and European markets for global expansion.

VP Sales Engineering

Vice PresidentVice PresidentOtherRemoteMid LevelTeam 201-500

Location

United States

Posted

90 days ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

VP Sales Engineering

Entersekt

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The VP of Sales Engineering is a pivotal role responsible for leading and managing a team of sales engineers who provide technical expertise and support to the sales department. This role combines the need for strong sales abilities, technical acumen, leadership, and effective communication skills to drive successful collaborations with prospects and partners. The end goal is to ensure the delivery of effective solutions to prospects and partners while meeting our organizational sales targets. This role will require leading a team that serves as trusted technical advisors to help the prospects make key technical decisions. The Sales Engineering group works closely with the Entersekt sales team to effectively position the technical platforms and assist with closing deals as the technical expert. This group will also assist, where needed, in managing technical relationships with partners and resellers, by ensuring the value proposition is well understood, and that the partners are appropriately skilled and equipped. The Sales Engineering group will be responsible for effective handoff to the Solution Delivery teams for the solution design and go-live phases. Additionally, post go-live engagement will be required to confirm that our solution works as expected and identify any upsell opportunities. Responsibilities - Engage with prospects’ technical stakeholders to understand pain points, identify use cases, articulate key differentiators of our solution, and address technical objections. - Analyse customer requirements to make sure that their needs are met by the solution proposed. - Produce white papers to both demonstrate industry leadership as well as to address pertinent questions from prospective customers. - Host technical deep-dive workshops and training sessions with customers’/partners’ technical resources, providing them with an in-depth understanding of the operation of the product and how best to utilize it within their organization. - Work with the Sales Engineering team to make a significant contribution to the customer’s overall solution design through review and consultation (network design, enterprise service design, mobile application design, and business process design). - Join the project manager in partaking in customer project progress meetings to provide risk mitigation support and best practice guidance. - Engage with Entersekt Product leadership to discuss required features and functionality to continue driving effective value proposition into the market. - Own the development of user assistance material to accelerate the adoption of new features. - Work with the Sales Engineering team to produce solution designs and specifications detailing product configuration, integration points, custom interfaces and technical risks and complexities. Qualifications - Engineering, Computer Science or relevant IT degree. - 15+ years’ experience in a software development environment, preferably in a customer-facing role. - Experience leading Sales Engineering teams, as well as successful partnership with sales teams to assist with quota attainment and market expansion. - Hands-on technical expertise: the ability to engage at a technical level with developers and system analysts on subjects such as networking, system-to-system API, mobile application development and business process design. - Experience in financial services, authentication, payments and fraud prevention industry beneficial. - North America experience as an added advantage. - Ability to understand and lead presales engagements. - Systems engineering and/or requirements management exposure will be an advantage. - The ability to understand technology and business strategy, with the keen interest to move between both worlds. - Strong customer focus and push for value & improvement. - Successfully self-motivated and self-managed. - Ability to translate user requirements into technical solutions that drive up differentiation or quality of marketing. Personality Attributes - Team player, self-starter, having an entrepreneurial mindset, and the ability to work in a matrixed organisation. - Ability to work in a fast paced Fintech environment filled with ambiguity, thus flexibility and an adaptive approach is key. - Strong technical communication skills: the ability to articulate the key differentiators of our solution and engage in technical discussions with customers. - Ability to host workshops and training sessions. - Unwavering focus for enabling each prospect/customer to get the most from our solutions. Benefits - Exposure to cutting-edge technology. - Colleagues who are leaders in their fields. - Awesome working environment that includes flexible hours and remote work. - Plenty of growth opportunities. Company Description Entersekt is a leader in digital banking fraud prevention and payment security, including mobile authentication, mobile app security, and 3-D Secure authentication for issuers, acquirers and payment networks. We offer highly scalable products with a track record of success across multiple continents. We exist to create a world where everyone can transact digitally without fear or compromise. Currently, we protect the digital transactions of over 210 million active users on our platform and hold 120 active patents that recognize innovation in digital security, payments, and user experience. Entersekt offers customers secure authentication and digital payments experiences that remove unnecessary friction. We have a diverse product portfolio and aggressive roadmap that positions the company well to sustain competitive advantage as it expands globally with emphasis on North America and European markets.

Job Requirements

  • Engineering, Computer Science or relevant IT degree.
  • 15+ years’ experience in a software development environment, preferably in a customer-facing role.
  • Experience leading Sales Engineering teams, as well as successful partnership with sales teams to assist with quota attainment and market expansion.
  • Hands-on technical expertise: the ability to engage at a technical level with developers and system analysts on subjects such as networking, system-to-system API, mobile application development and business process design.
  • Experience in financial services, authentication, payments and fraud prevention industry beneficial.
  • North America experience as an added advantage.
  • Ability to understand and lead presales engagements.
  • Systems engineering and/or requirements management exposure will be an advantage.
  • The ability to understand technology and business strategy, with the keen interest to move between both worlds.
  • Strong customer focus and push for value & improvement.
  • Successfully self-motivated and self-managed.
  • Ability to translate user requirements into technical solutions that drive up differentiation or quality of marketing.
  • Personality Attributes
  • Team player, self-starter, having an entrepreneurial mindset, and the ability to work in a matrixed organisation.
  • Ability to work in a fast paced Fintech environment filled with ambiguity, thus flexibility and an adaptive approach is key.
  • Strong technical communication skills: the ability to articulate the key differentiators of our solution and engage in technical discussions with customers.
  • Ability to host workshops and training sessions.
  • Unwavering focus for enabling each prospect/customer to get the most from our solutions.

Benefits

  • Exposure to cutting-edge technology.
  • Colleagues who are leaders in their fields.
  • Awesome working environment that includes flexible hours and remote work.
  • Plenty of growth opportunities.

Related Categories

Related Job Pages

More Vice President Jobs

The Vice President/Senior Vice President is responsible for generating new business and expanding existing accounts through a consultative sales approach. During the interview process, we will determine the appropriate title based on years of experience and other qualifications. This role requires a deep understanding of the nonprofit philanthropy sector and the ability to effectively communicate the value of Graham-Pelton's services to prospective clients. The VP/SVP will work closely with Sales and Marketing teams to develop and execute strategies that drive revenue growth. Responsibilities: - Commitment to the firm's core values, our mission, and Our Why - Serving as a model for Graham-Pelton's "responsible sales" and "responsible consulting" approach - Lead and participate in all sales activities including but not limited to identifying opportunities for service, discovery and qualification outreach, meet and greets, proposal generation, pitches, and relationship management - Serve as an active and collaborative member of the team, partnering with colleagues on strategy and implementation. - Consistently utilize the firm's sophisticated systems and technology to monitor and guide sales activity. - Plan and oversee seminars and other small gatherings of clients and potential clients and represent Graham-Pelton at conferences. - Collaborate with the marketing team to meet firm-wide strategies and business development objectives. - Work with Graham-Pelton professional staff to provide communication to potential clients including personal emails, group electronic/social media communication, direct mail, and surveys. Client Service/Account Management - Provide high-level leadership to project teams. - Work closely and effectively with consulting teams to deliver service and ensure service renewals - As the supervisor of accounts, provide and ensure the highest quality client service while also providing leadership and mentorship to Graham-Pelton colleagues - Work closely with managing consultants to support accounts to meet the firm's key performance indicators and ensure strong, ongoing client relationships and satisfaction Requirements: - Bachelor's degree in a relevant field - Previous experience with a demonstrated track record of success in sales, fundraising, and development, and/or transferrable professional services experience - Demonstrated record of meeting or exceeding fundraising or sales targets - Entrepreneurial, self-starter spirit and optimistic attitude with the ability to keep up with a fast-paced, ever-changing environment - Emotional intelligence, sound judgment, and superb critical thinking and communication skills - Ability to work remotely and travel (driver's license required) Preferred skills and experience: - Proficiency with Microsoft Office Suite - Proficiency with Salesforce CRM or other similar tools - Strong preference for candidates with experience in selling fundraising professional services

United States
OtherRemoteTeam 11-50

ROLE: Vice President Regulatory Affairs DEPARTMENT: Regulatory Affairs REPORTING TO: Chief Medical Officer LOCATION: The Ambros corporate office or remote from the Employee’s home office SALARY BAND: $275,000 to $335,000 with a 30% target bonus. Final compensation will be commensurate with the candidate’s experience, education, skills, and overall alignment with the role’s requirements. EQUITY GRANT ELIGIBLE: Yes POSITION SUMMARY: Reporting to the Chief Medical Officer (“CMO”), the Vice President Regulatory Affairs will play a critical strategic, leadership, and contributor role in developing and executing regulatory strategies and tactics to support Ambros Therapeutics, Inc.’s (“Ambros” or the “Company”) clinical development programs and future commercial success. This leader will oversee all regulatory activities including submissions, interactions with health authorities, and compliance with applicable regulations in the US, and, as applicable, globally. This role will serve as the Company’s primary liaison to the U.S. Food and Drug Administration (“FDA”) and other regulatory bodies as needed and will provide cross-functional leadership to ensure that all development and registration activities align with the Company’s strategic objectives and regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES - Lead the development and implementation of comprehensive regulatory strategies for Ambros’ clinical and manufacturing programs, promotional review, and regulatory filings. - Play a leadership role, along with the VP Clinical and other functions in the preparation, review, and submission of all regulatory filings including Investigational New Drug (“IND”), New Drug Application (“NDA”), and Annual Reports,” and briefing packages for Health Authority meetings. Participate in the development and review of Investigator’s Brochures (“IB”), Development Safety Update Report (“DSUR’”) and similar documents. - Serve as the company’s primary liaison with the FDA and other global health authorities; coordinate and lead key regulatory interactions and negotiations. - Direct and ensure regulatory compliance across all development stages and geographies. - Develop and update, with cross functional team input, target product profile(s) - Assess existing data from legacy companies that contribute to an NDA and assess for actions needed to gain alignment with the FDA. - Partner with cross-functional leadership (Clinical Sciences, Clinical Operations, CMC, toxicology, Safety, Medical Writing, and Quality) to ensure robust and compliant regulatory documentation and submissions. - Provide strategic input to senior management on regulatory pathways, risk assessment, and mitigation plans for global development programs. - Lead preparation for and execution of regulatory meetings - Oversee regulatory intelligence and proactively assess evolving US regulations (and global, as relevant), guidelines, and policies that impact Ambros’ programs. - Guide the development of internal regulatory procedures, Standard Operating Procedures (“SOPs”), and documentation standards in partnership with Quality. - Manage relationships with external consultants, Contract Research Organizations (“CROs”), and publishing vendors to ensure timely and accurate submission delivery. - Contribute to due diligence and regulatory strategy assessments for potential business development or partnership opportunities. - Recruit, develop, lead and mentor a high-performing Regulatory Affairs team as Ambros progresses towards an NDA. - Partner with Legal, Quality, and Clinical functions to maintain inspection readiness and ensure compliance with GXP standards. - Provide regular regulatory updates to executive management and the Board of Directors. - Other duties as assigned. MINIMUM EXPERIENCE, EDUCATION, CERTIFICATIONS, & LICENSES: - Advanced degree (PharmD, PhD, MD, or MS) in a scientific or regulatory discipline required. - Minimum of 8 to 10 years of progressively increasing responsible regulatory experience in the biotechnology or pharmaceutical industry. - Extensive experience leading IND and other regulatory submissions relevant to a medicine in late-stage development through filing, approval and commercialization. - Experience in orphan diseases and FDA-related regulations, policies and approaches on pediatric written requests is a plus. - Extensive experience with successfully interacting with FDA; experience the Division of Anesthesia, Addiction Medicine and Pain Medicine (DAAP) or General Endocrinology is a plus; experience with other global regulatory authorities is a plus. - Deep knowledge of US regulatory requirements, including FDA and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) guidelines. - Proven ability to design and implement regulatory strategies for small molecules; sterile injectable experience is a plus. - Strong leadership background with experience building and managing regulatory teams in a fast-paced, matrixed environment. SKILLS & QUALIFICATIONS: - Strategic thinker with demonstrated ability to anticipate regulatory trends and shape development strategies accordingly. - Exceptional leadership, collaboration, and communication skills with ability to influence across all levels of the organization. - Strong project management capabilities and proven ability to manage multiple complex priorities simultaneously. - Expert-level knowledge of regulatory submission processes, including Electronic Common Technical Document (“eCTD”) and electronic publishing. - Excellent analytical and problem-solving skills; adept at making sound judgments under pressure. - Highly skilled at the translation of complex data into clear, credible narratives. - Superior verbal, written, and presentation communication skills in English, with the ability to engage effectively across all levels of the Company and with external stakeholders (e.g. Health Authorities, regulators, and medical and scientific experts). - Upholds high ethical standards and maintains scientific and regulatory integrity in all activities. - High degree of professionalism and commitment to operational excellence. - Must have knowledge of and be willing to comply with all regulatory requirements, compliance standards and regulations, Ambros’ SOPs and polices, and industry best practices consistent with the role and Company policies. - Ability to read and comprehend complex materials, including medical, scientific, and regulatory literature, policies, procedures, and instructions in English; write reports and memos; use logic and data to solve problems; assess needs and take appropriate actions; all with reasonable independence, business judgment, and professional discretion. - Proficiency in Microsoft Office Suite and document management systems (e.g., Veeva). WORK LOCATION AND TRAVEL REQUIREMENTS: This position is based from an Ambros corporate office or remote from the Employee’s home office, subject to Company policy and business needs. If remote, a dedicated home office space that is professional in appearance, quiet, and secure where confidential conversations can occur and a high-quality high-speed internet connection are required. Regardless of primary work location, the role requires in-person presence approximately once per month for multi-day meetings at the corporate headquarters or other designated locations, as determined by business or department priorities. Regular domestic and international travel is required, including overnight stays. Travel expectations may reach up to 20%, depending on operational priorities and Company needs. PHYSICAL REQUIREMENTS & ENVIRONMENTAL CONDITIONS This position is primarily performed in a professional office or home-office setting. With or without reasonable accommodation, the employee must be able to: - Operate a computer and standard office equipment. - Communicate effectively in person, via telephone, and through video conferencing platforms. - Travel independently, including overnight and international trips, and travel by personal vehicle and transit systems. - Navigate office environments and other professional settings. Additional requirements include: - Prolonged periods of sitting, standing, and walking. - Occasional lifting or carrying of items up to 20 pounds. - Ability to read, comprehend, and apply policies, procedures, and regulations written in English. - Ability to write clear, factual, and grammatically correct communications and reports in English. - Ability to use logic and data for problem-solving and to exercise sound judgment. EQUAL EMPLOYMENT OPPORTUNITY As an equal opportunity employer, Ambros is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation, transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by applicable law. All employees, officers, and representatives of Ambros are expressly prohibited from engaging in unlawful discrimination, harassment, or retaliation. Consistent with all applicable requirements, Ambros will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless doing so would create an undue hardship on the Company. Ambros also follows all applicable federal, state, and local laws governing work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and Immigration Reform and Control Act. Ambros is an E-Verify employer. REASSIGNMENT OF DUTIES AND AT-WILL EMPLOYMENT Nothing in this job description restricts Ambros’ right to assign or reassign duties, responsibilities, and work locations of this role at any time in its sole discretion. While this job description generally reflects Ambros’ current assessment of the essential functions for this role, it is not intended to be a complete list of the duties and responsibilities of this role, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time. Employment with Ambros is “at-will,” meaning that either the Company or the employee may terminate the employment relationship at any time, with or without cause or notice, reason, or justification, subject to applicable law.

United States
$275K - $335K / year
OtherRemoteTeam 51-200

Vice President, Biostatistics Remote Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn. Uniquely Differentiated. Rapid. Elegant. At Cabaletta, we are driven by the shared mission of developing cures, where a patient’s own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work® Position Description: This role can be based out of our Philadelphia, PA headquarters, hybrid, or remote (strong preference for candidates based in the Northeast). The Vice President, Biostatistics is a key enterprise leader responsible for setting the strategic direction, vision, and executional rigor of the company’s biostatistics and data management capabilities. Reporting to the VP, Clinical Development, this leader will serve as the principal statistical authority across the organization—guiding program strategy, influencing portfolio decisions, and ensuring statistical excellence from early development through registration-stage programs. This role requires deep expertise in statistical methodologies, strong scientific judgment, and the ability to anticipate what is required to advance complex clinical programs in a dynamic environment. The ideal candidate will balance scientific rigor with operational pragmatism, provide leadership across functions, and communicate effectively with executive leaders, scientific teams, regulators, and external partners. As a senior leader in a fast-paced, growing company, the VP will also be instrumental in building organizational capability, advancing operational excellence, and fostering a high-performing, collaborative culture aligned with our values. Key Responsibilities: - Lead and develop the Biostatistics and Data Management functions, developing a long-term vision, operating model, and high-performance culture. - Recruit, mentor, and inspire the team to ensure organizational capability scales with the company’s clinical portfolio. - Serve as a strategic advisor to executive leadership on statistical risk, trial feasibility, portfolio trade-offs, and data-driven decision making. - Provide expert statistical input into clinical development strategy, protocol concepts, study design, and endpoint selection to optimize probability of technical and regulatory success. - Drive innovative statistical approaches, adaptive designs, and data-driven methodologies to accelerate development timelines and enhance the robustness of clinical findings. - Ensure all statistical strategies align with regulatory expectations and meet the needs of future submissions, inspections, and commercial planning. - Oversee development and execution of statistical analysis plans, data review strategies, and inferential methodologies for all clinical studies. - Ensure the integrity, quality, reproducibility, and validation of statistical analyses, including submission-ready documentation. - Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and other teams to ensure seamless execution and data-driven decision making. - Provide statistical leadership for regulatory interactions and submissions, including authoring and reviewing statistical components of BLAs, briefing packages, responses, and advisory committee materials. Late stage development experience is strongly preferred. - Represent the company in regulatory meetings as needed and ensure alignment with global regulatory standards and evolving guidance. - Oversee CROs, data vendors, and technology platforms to ensure high-quality deliverables, on-time execution, and compliance with regulatory and industry standards. - Champion modern data management and statistical computing practices, ensuring infrastructure supports scale, audit readiness, and efficiency. - Stay abreast of emerging statistical methodologies, regulatory trends, and industry best practices to ensure the organization remains at the forefront of scientific and statistical innovation. Qualifications: - PhD or Master’s degree in Biostatistics, Statistics, or related field. - 10+ years of relevant experience in biotech/pharmaceutical R&D, including leadership of statistical strategy for early and late-stage clinical programs. Leadership & Strategic Impact - At least 7 years leading Biostatistics teams, including management of statisticians, programmers, and/or data management groups. - Demonstrated success in shaping statistical strategy for pivotal trials and regulatory submissions. - Proven ability to influence senior stakeholders, navigate ambiguity, and drive alignment across cross-functional teams. - Strong track record of contributing to late-stage development/regulatory submissions with BLA experience strongly preferred. - Deep understanding of global regulatory guidelines, data requirements, clinical operations interfaces, and inspection readiness. - Exceptional communication skills with ability to translate complex statistical concepts into clear, actionable insights for diverse audiences. - Experience managing departmental budgets, vendor relationships, and technical infrastructure. - Highly collaborative, with strong interpersonal skills and the ability to build trust across teams. - Strategic thinker with strong scientific rigor and operational pragmatism. - Thrives in a fast-paced, evolving environment; able to manage multiple priorities with clarity and focus. - Demonstrates integrity, accountability, and a commitment to continuous learning and team development. - Comfortable with hands-on leadership in a small-company environment. Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression. For more information, please visit https://www.cabalettabio.com/join-our-crew Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans. Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation. And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm. #LI-REMOTE

United States
OtherRemoteTeam 51-200

Vice President, Regulatory Affairs Remote Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn. Uniquely Differentiated. Rapid. Elegant. At Cabaletta, we are driven by the shared mission of developing cures, where a patient’s own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work® Position Description: This role can be remote or based out of our Philadelphia, PA headquarters. Reporting to the Chief Medical Officer, the Vice President of Regulatory Affairs is responsible for driving success and will lead the global regulatory strategy and execution for an advanced cell therapy product development program. This role is responsible for ensuring compliance with all applicable regulations, guiding interactions with health authorities (FDA, EMA, and other global agencies), and driving successful regulatory submissions and approvals. The VP will serve as a key member of the product development team, influencing development strategy and lifecycle management for autologous cell therapy products. Key Responsibilities: Strategic Leadership - Develop and implement global regulatory strategies for cell therapy programs across clinical development, manufacturing, and commercialization. - Serve as the primary regulatory advisor to executive leadership, ensuring alignment with corporate objectives and regulatory requirements. - Anticipate and interpret evolving regulatory trends in cell and gene therapy, including FDA CBER guidance and EMA ATMP frameworks. - Assess and communicate potential regulatory risks and propose mitigation plans. Regulatory Submissions & Compliance - Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development. - Oversee content preparation and submission of INDs, CTAS, and BLAs/MAAs, and other relevant submissions to regulatory agencies. - Lead strategy for global expedited pathways (e.g. RMAT, Priority Review, PRIME), orphan designation, and pediatric study plans (US and EU), where applicable. - Ensure compliance of programs and submission documentation for adherence to GxP, ICH, and regional regulatory requirements throughout development and manufacturing. Regulatory Interactions - Build and maintain strong relationships with FDA CBER and other regulatory agencies and represent the company in key regulatory meetings and negotiations. - Ensure timely and high-quality responses to health authority inquiries, including pre-BLA meetings, Type B/C/D meetings, and scientific advice. Team Leadership - Build and manage a high-performing regulatory affairs, operations, writing, and CMC regulatory with expertise in cell and gene therapy. - Foster a culture of compliance, innovation, and continuous improvement. - Coach team members on technical skills and leadership behaviors. Qualifications: - Advanced degree in life sciences, pharmacy, or related field (PhD, PharmD, or equivalent preferred). - 15+ years of regulatory affairs experience in biopharmaceuticals from pre-clinical to commercialization, with at least 8 years in leadership roles. - Experience in cell and gene therapy field is preferred - Proven track record of successful IND and BLA submissions (prior BLA experience required) - Deep knowledge of FDA CBER regulations, EMA ATMP guidelines, GxPs, and global regulatory frameworks. - Strong leadership, strategic thinking, and negotiation skills. - Excellent communication and stakeholder management abilities. - Strong team orientation and passion for continuous self-development Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression. For more information, please visit https://www.cabalettabio.com/join-our-crew Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans. Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation. And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm. #LI-REMOTE

United States