Serves as a senior regulatory authority and trusted strategic partner to pharmaceutical and biotech C-suite executives, influencing enterprise-wide regulatory strategies.
Partners with the SVP & Practice Lead to shape the future direction of the Clinical & Regulatory practice, driving practice growth and translating regulatory landscape evolution into opportunities.
Proactively supports the practice's P&L, achieving annual revenue targets, leading pursuit strategies for high-value engagements, and setting delivery quality standards across the regulatory team.
Works collaboratively within CMC regulatory and technical operation teams on writing projects for early, late-stage development, and commercial programs.
Contributes to drafting, reviewing, and finalizing CMC content and regulatory documents such as Module 3 sections for INDs, BLAs, and MAAs.
Plans and manages writing projects, ensuring documents meet quality standards and adhere to corporate SOPs and evolving global regulations.
Iovance Biotherapeutics aims to be the global leader in developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are an innovative biotechnology company pioneering a transformational approach to treating cancer by harnessing the human immune system.
Provide strategic leadership for biometrics across all clinical development programs.
Define and implement an integrated biometrics strategy supporting clinical trial design and data quality.
Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team and a strong financial foundation, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Serve as embedded regulatory thought partner to Clinical and Operations teams, providing real-time guidance.
Partner with Clinical and Compliance team on policy development, audit response, and remediation strategies.
Translate complex healthcare regulations into practical guidance and tools.
Headway is building a new mental healthcare system everyone can access by solving the biggest barrier to care: insurance. They have over 75,000 providers across all 50 states run their practice on their software, serving over 1 million patients.
Strategically orchestrate the end-to-end journey for complex key account customers globally.
Partner with Marketing, Sales, and Product Management to ensure CX strategy supports objectives and product launches.
Ensure all customer touchpoints comply with global healthcare regulations and cGMP.
LGC delivers Science for a Safer World through research and impactful disease diagnosis. They foster an environment that encourages scientific advancement, cultivating passion for discoveries and role development.
Develop and execute medical affairs strategies aligned with company goals.
Build and maintain strong relationships with HCPs, KOLs, and patient advocacy organizations.
Collaborate with the CMO to establish high-integrity, compliant processes for HCP and KOL engagement.
Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. Every program reflects their commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
Analyze & identify the optimal positioning to successfully deploy our science, models and products.
Identify, negotiate, and manage strategic partnerships with key stakeholders in biopharma.
Drive revenue growth by meeting or exceeding business development targets.
Bioptimus is building the first universal AI foundation model for biology to fuel breakthrough discoveries and accelerate innovation in biomedicine. With more than $75M in funding, our fast-growing start-up is headquartered in Paris and backed by leading international venture capitalists.
Partner with Regulatory leads to manage regulatory filing subteams and subteam operations.
Develop and maintain high level and detailed regulatory timelines that utilize project management software tools.
Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays.
Ultragenyx is a biopharmaceutical company committed to addressing unmet medical needs in the field of rare diseases. With a focus on innovation and patient-centricity, they strive to develop life-changing treatments and improve the lives of patients and caregivers.
Own the end-to-end lifecycle of FDA premarket applications, with an immediate focus on authoring and steering 510(k) submissions to clearance.
Operationalize and maintain compliance across diverse and intersecting jurisdictions, including FDA (Device, Drug & Compounding) and CMS (CLIA/CAP).
Build and scale the "Technical Playbook" for medical product operations, ensuring the company stays ahead of shifting state, federal, and international regulations.
Hims & Hers is a health and wellness platform committed to better health by offering affordable and personalized care. As a public company traded on the NYSE, they are normalizing health & wellness challenges and innovating on their solutions to make better health outcomes easier to achieve.
Provide technical and strategic leadership for late-stage CMC activities.
Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports.
Lead CMC meetings and ensure teams are aligned with overall CMC and program strategy.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. They aim to offer patients suffering from chronic skin diseases the greatest possible freedom from their condition. The company seeks passionate individuals eager to contribute to an engaged, inclusive, and positive company culture.
Define and execute the scientific vision and R&D roadmap aligned with company milestones.
Oversee lead preclinical programs in focus indications, such as tRNA elevation in neuromuscular diseases.
Drive IND-enabling studies, including biodistribution, toxicology, and dose-finding.
XtRNA Bio is a pioneering biotechnology company developing a proprietary tRNA therapeutic platform for underserved patients with rare genetic diseases and high unmet medical needs. They are advancing a novel approach to correct translational defects at their root, from discovery through to the clinic — with a focus on meaningful, durable benefit for patients who currently have no options.
Lead and develop regional sales and account management teams to deliver strong performance and achieve commercial objectives.
Drive execution of a unified commercial strategy across geographies in alignment with enterprise priorities.
Build scalable processes, infrastructure, and performance management systems to support growth.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. The company's core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business and are exemplified by each and every one of their team members.
Define and own KIPP's enterprise-wide growth and scale strategy, including multi-year targets and portfolio priorities.
Lead the Foundation's partnership with regions pursuing growth, driving strategy, ensuring accountability, and managing a team.
Set vision and standards for network growth, ensuring every scale decision is evidence-based, equity-centered, and aligned with strategy.
KIPP Foundation is a nonprofit organization that supports a national network of public charter schools focused on preparing students for college, career, and beyond. The organization fosters a mission-driven culture with nearly 210,000 students and alumni across 279 schools and employs nearly 16,500 educators.
Cultivate relationships with C-Suite executives and maintain a strong executive presence.
Lead the implementation and delivery of the Strategic Services portfolio.
Create and manage customer Success Plans that align with each institutions’ goals.
Civitas Learning helps colleges and universities apply their student data to maximize institutional impact and improve student outcomes. Their flexible Student Impact Platform creates actionable insights, enabling higher education institutions to pinpoint students at risk.
Serve as the primary analytics executive responsible for driving client success through advanced modeling and real-time marketing optimization.
Define the analytics strategy within a compliant framework, establish and manage priorities across the team.
Ensure projects are executed on time, within scope, and at a consistently high standard of quality.
Zeta Global is an AI-Powered Marketing Cloud that leverages AI and consumer signals to help marketers acquire, grow, and retain customers efficiently. They have offices around the world and aim to make sophisticated marketing simple by unifying identity, intelligence, and omnichannel activation into a single platform.
Lead regional regulatory strategy for electric transmission projects.
Foster trust and relationships with regulatory agencies and government officials.
Advocate for policies that support the development of efficient infrastructure.
Grid United aims to solve the largest barrier to a more reliable, resilient and affordable grid by developing new long-haul electric transmission lines in the United States. Established in 2021 by proven industry leaders, Grid United is developing utility-scale, multi-state electric transmission projects that will provide long-term economic benefits to communities across the country.
Develop advocacy with key stakeholders and KOLs within the head and neck cancer space, to support the continued success of LOQTORZI.
Lead external engagements and support in-line brand marketing initiatives for LOQTORZI.
Develop a strategic Regional engagement plan in coordination with cross functional partners.
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of novel immuno-oncology therapies. At Coherus, they provide equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment.
Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program.
Develop policies and procedures that provide appropriate guidance and instruction to Company employees.
Lead the development and delivery of compliance training programs for employees at all levels.
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. They aim to provide significantly better survival rates with dramatically fewer risks. They have a start-up culture of camaraderie and leadership by example.
Own and lead zerohash’s licensing and registration strategy across North America and other Americas jurisdictions.
Design, implement, and continuously improve risk-based compliance programs that are operable across multiple jurisdictions.
Maintain deep working knowledge of zerohash’s AML/BSA regulations, current money laundering typologies, and investigative techniques.
Zerohash is the leading crypto and stablecoin infrastructure platform and the operating system for digital money, powering the next generation of financial services. Founded in 2017, zerohash enables banks, brokerages, fintechs, and payment companies to offer crypto trading, stablecoin payments, and tokenized assets without having to build or manage complex blockchain infrastructure on their own.
Conducts risk assessments and internal/external partner reviews.
Develops and implements risk mitigation strategies.
Advises leadership on risk-related decisions.
Pathward is a financial empowerment company that collaborates with innovators to broaden financial availability, choice, and opportunity. They are dedicated to removing traditional barriers to financial access and fostering economic mobility, with a team of problem solvers who celebrate differences and value diverse perspectives.
Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s).
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, they are developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.