If you are interested in any of the open positions below, please contact us at careers@inozyme.com.
Position Overview:
As the Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscape and ensuring compliance with regulatory requirements.
You will develop and implement US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. You will collaborate closely with cross-functional teams, including Clinical Development, Medical Affairs, Quality Assurance, and Commercial, to achieve regulatory milestones and support successful product development and commercialization.
Reporting Relationship: This position will report to the VP of Regulatory Affairs, Medical Writing & Pharmacovigilance
About Inozyme Pharma:
Inozyme Pharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases that affect bone health and blood vessel function. We are experts in the PPi-Adenosine Pathway, where the ENPP1 enzyme generates inorganic pyrophosphate (PPi), which regulates mineralization, and adenosine, which controls intimal proliferation (the overgrowth of smooth muscle cells inside blood vessels). Disruptions in this pathway impact the levels of these molecules, leading to severe musculoskeletal, cardiovascular, and neurological conditions, including ENPP1 Deficiency, ABCC6 Deficiency, calciphylaxis, and ossification of the posterior longitudinal ligament (OPLL).
Our lead candidate, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to increase PPi and adenosine, enabling the potential treatment of multiple diseases caused by deficiencies in these molecules. It is currently in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. By targeting the PPi-Adenosine Pathway, INZ-701 aims to correct pathological mineralization and intimal proliferation, addressing the significant morbidity and mortality in these devastating diseases.
Essential Duties and Responsibilities:
Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
- Develop and implement global regulatory strategies for rare disease therapeutic programs, ensuring alignment with corporate objectives and regulatory requirements.
- Accountable for preparation and execution of regional aspects of the regulatory global strategy. Can include setting direction for junior staff to execute regional regulatory tasks according to strategy.
- Provide strategic guidance and leadership to cross-functional teams on regulatory requirements, agency interactions, and submission strategies throughout the product lifecycle.
- Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, BLAs, NDAs, and other relevant filings, ensuring compliance with applicable regulations and guidelines.
- Monitors the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs
- Proactively monitor and analyze regulatory trends, guidelines, and developments related to rare disease therapies, and provide strategic recommendations to senior management.
- Serve as the primary point of contact for regulatory agencies (FDA, EMA, etc.), representing the company in interactions, meetings, and negotiations.
- Collaborate with cross-functional teams to develop and execute regulatory communication plans, including scientific advice meetings, pre-submission meetings, and regulatory authority interactions.
- Build and maintain effective relationships with key stakeholders, including regulatory agencies, key opinion leaders, and external consultants.
- Stay current with evolving regulatory requirements and best practices, and ensure compliance with all applicable regulations, guidelines, and industry standards.
- Provide regulatory guidance and support to internal teams to ensure compliance with regulatory obligations throughout the organization.
- Mentor and develop regulatory team members, fostering a culture of excellence, collaboration, and continuous learning.
Educational Qualifications: Advanced degree (Ph.D., Pharm.D., or equivalent) in life sciences or a related field.
Additional Qualifications:
- Minimum of 10 years of regulatory affairs experience in the biopharmaceutical industry, with a focus on rare diseases and orphan drug development.
- Strong knowledge of global regulatory requirements and guidelines for drug development and registration, including FDA and EMA regulations.
- Proven track record of successfully leading regulatory strategy and submissions for rare disease therapeutic programs.
- Experience with regulatory interactions, including FDA meetings (pre-IND, end-of-Phase 2, pre-NDA, etc.) and EMA scientific advice procedures.
- Demonstrated ability to provide strategic regulatory guidance and effectively communicate complex regulatory information to cross-functional teams and senior management.
- Strong leadership and people management skills, with the ability to motivate and develop high-performance teams.
- Excellent written and verbal communication skills, with the ability to influence and negotiate with internal and external stakeholders.
- Ability to work effectively in a fast-paced, dynamic environment with a high degree of flexibility and adaptability.
Position Overview:
The Clinical Project Manager / Sr. Clinical Project Manager (CPM) provides operational leadership of one or more clinical trials from protocol development through clinical study report, and ensure activities are executed in accordance with the protocol, ICH/GCP guidelines, applicable regulations, and company's policies and procedures and corporate goals. Responsibilities may include leading cross-functional study team(s) and/or the oversight of Contract Research Organizations (CRO) and vendors. The CPM will have a command of assigned studies, the ability to flex and adapt to dynamic situations, and will utilize critical thinking skills to facilitate risk mitigation analyses and problem solving.
Reporting Relationship: The position will report to the Vice President, Worldwide Clinical Operations & Site Strategy
About Inozyme Pharma:
Inozyme Pharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases that affect bone health and blood vessel function. We are experts in the PPi-Adenosine Pathway, where the ENPP1 enzyme generates inorganic pyrophosphate (PPi), which regulates mineralization, and adenosine, which controls intimal proliferation (the overgrowth of smooth muscle cells inside blood vessels). Disruptions in this pathway impact the levels of these molecules, leading to severe musculoskeletal, cardiovascular, and neurological conditions, including ENPP1 Deficiency, ABCC6 Deficiency, calciphylaxis, and ossification of the posterior longitudinal ligament (OPLL).
Our lead candidate, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to increase PPi and adenosine, enabling the potential treatment of multiple diseases caused by deficiencies in these molecules. It is currently in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. By targeting the PPi-Adenosine Pathway, INZ-701 aims to correct pathological mineralization and intimal proliferation, addressing the significant morbidity and mortality in these devastating diseases.
Essential Duties and Responsibilities:
- Lead cross-functional teams to ensure studies are conducted one time, with quality and within budget
- Develop and maintain study timelines through collaboration with internal and external stakeholders; ensure timelines remain on track through ongoing communication, collaboration and risk-mitigation strategies
- Drive study start-up activities, including site and vendor identification, feasibility and selection
- Effectively model and manage patient enrollment forecasts; implement risk mitigation strategies to ensure enrollment remains on track
- Develop oversight plans for outsourced services; oversee vendors, including CROs, third-party vendors and consultants to ensure the timeliness and quality of services performed
- Partner with CMC/clinical supplies to calculate drug projections and contribute to design and packaging of study supplies
- Oversees monitoring and monitor performance, including adherence to the monitoring plan and applicable SOPs
- Conduct monitoring oversight visits and site engagement visits to ensure the quality of vendor and site performance
- Ensure effective and timely contract and budget negotiations with clinical sites and vendors
- Lead and/or contribute to study risk assessment and risk mitigation. Proactively communicate risks to study members and senior staff.
- Oversee the management of the electronic Trial Master File (TMF); ensure the TMF is created, maintained, monitored and closed out in accordance with the TMF plan and study timelines
- Facilitate and manage cross-functional interactions with internal and external stakeholders to ensure relevant and timely communication of information and materials for decision making purposes as well as ensure adherence to study timeline.
- Collaborate with medical research, data management, biostatistics, pharmacovigilance, and other functions to ensure data is processed in a timely manner for ongoing data review, interim analyses and final database lock.
- Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, DSURs, monitoring plans and reports.
- Review and approve corrective action plans, participate in study-related audits.
- Actively contribute to and implement best practices and standards for study management; participate in the development of initiatives and process improvement within Clinical Operations
- Approach problem solving with a strategic, action oriented and positive attitude.
- Manage/mento/train junior staff by actively participating in documentation, sharing industry standards, implementation of trial conduct best practices, and lessons learned
- Assist with the development of policies, procedures and best practices in support of operational excellence
- Other duties as assigned.
Educational Qualifications: A Bachelor's degree or higher degree (scientific discipline preferred)
Additional Qualifications:
- 4-7 years in trial management with a sponsor company managing various phases of clinical trials.
- Experience overseeing vendors, including identification and mitigation of risks.
- Experience leading cross-functional teams and meetings.
- In-depth understanding of ICH/GCP guidelines and FDA regulations.
- Understanding/working knowledge of Microsoft Word and Excel and Microsoft Project.
- Critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive study(ies) and understand implications of decisions that affect study outcomes and timelines.
- Strong interpersonal and negotiation skills.
