Opportunities - Inozyme

If you are interested in any of the open positions below, please contact us at careers@inozyme.com.

Position Overview:

We are seeking a highly motivated and experienced Associate, Benefits and HR Compliance, (Compensation experience a+) to join our dynamic organization. The ideal candidate will have a strong background in benefits administration, data analysis, and compliance management, with specific experience in life biotechnology, or other areas of the pharmaceutical sector. This role will be essential in ensuring our metrics are credible and our benefits programs are competitive, compliant with regulations, and aligned with organizational goals.

Reporting Relationship: This person will report to the SVP & Chief People Officer

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:

Benefits Administration:

Oversee the design, implementation, and management of employee benefits programs, including health, dental, retirement plans, and other employee perks.
Evaluate and recommend enhancements to benefit offerings based on industry trends, employee feedback, and budget considerations.
Ensure benefits programs comply with applicable laws and regulations.

Compliance Oversight:

Ensure compliance with federal, state, and local labor laws and regulations related to compensation and benefits.
Stay updated on legal and regulatory changes affecting employee benefits and compensation, and communicate implications to management.
Prepare and submit required reports and documentation to relevant regulatory agencies.

Policy Development and Implementation (own the EE Handbook):

Develop, update, and implement HR policies and procedures related to compensation and benefits.
Provide guidance and support to HR staff and management regarding compliance and benefits-related inquiries.

Cross-Departmental Collaboration:

Work closely with finance, legal, and other departments to analyze trends and ensure alignment with organizational financial goals.
Collaborate with recruiting and talent management teams to integrate benefits (and compensation) strategies into talent acquisition and retention efforts.

Employee Engagement and Communication:

Develop communication strategies to inform employees of benefits programs +.
Conduct training sessions and workshops on key compliance and benefits changes to enhance employee understanding and engagement.

Educational Qualifications: Bachelor’s degree in Human Resources, Business Administration, or related field; Master’s degree or HR certification (e.g., SHRM-CP, CCP) a +.

Additional Qualifications:

Minimum of 5 years of experience in benefits/compensation, and compliance roles, preferably within the life sciences, biotech, or pharmaceutical industries.
Expert knowledge of federal and state labor laws, benefits regulations, and compensation best practices, with a willingness to research and stay abreast of changes and trends.
Exceptional analytical and problem-solving skills, with the ability to interpret complex data and make sound recommendations and informed decisions.
Excellent communication and interpersonal skills, with the ability to develop positive relationships at all levels of the organization.
Proficient in HRIS and compensation management software; advanced Excel skills preferred.

Associate Director, Sterile Drug Products & Vendor Management

Position Overview:

We are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. You will play a key role in vendor management and act as the subject matter expert for sterile drug products.

Reporting Relationship: This person will report to the Senior Director, Drug Product

About Inozyme Pharma:

Essential Duties and Responsibilities:

Strategic Leadership:

Execute strategic plans for drug product manufacturing, process validation, and BLA preparation, aligning with company goals.
Collaborate with cross-functional teams and CDMOs to identify risks and opportunities for process optimization, manage quality and regulatory risks, and develop solutions.
Drive cGMP manufacturing timelines and product release milestones.

Sterile Drug Product Expertise:

Oversee the production of sterile drug products, ensuring their quality, efficacy, and stability.
Implement best practices and stay updated on industry trends in sterile drug product manufacturing.

Vendor Management:

Act as primary point of contact for CDMOs and manage vendors for sterile drug product manufacturing day to day activities.
Ensure effective communication and collaboration with vendors to achieve project goals and timelines.
Act as person in plant during manufacturing campaigns. Travel to CDMOs for new project kick- off meetings and regular business review meetings.

Database Management:

Develop and maintain comprehensive databases for sterile drug product development and manufacturing data.
Ensure data integrity and compliance with regulatory requirements.

Process Optimization:

Collaborate with CDMOs to design and implement scalable drug product manufacturing processes.
Identify and implement efficiency improvements to maximize yields and cost-saving initiatives reduce DP cost of goods.

Quality Assurance & Regulatory Compliance:

Collaborate with the Quality Assurance department to guarantee product quality and regulatory compliance.
Prepare for and participate in regulatory inspections and audits, providing required documentation and support.
Ensure all drug product activities adhere to GMP guidelines and regulatory requirements.

Documentation & Reporting:

Maintain comprehensive and accurate documentation of all drug product manufacturing processes and development history/data.
Prepare/compile/assemble technical reports and source documents for regulatory authorities as needed.
Collaborate with cross-functional teams, Quality and Regulatory functions, and CDMOs to ensure compliance, science-based decisions, accuracy, and completeness of technical documents and submissions.

Travel Requirements:

Ability to travel 10-20% of time to support external vendor activities.

Educational Qualifications: PhD in Pharmaceutical Sciences, Biotechnology, or related fields preferred

Additional Qualifications:

Minimum 8 years of experience in GMP-regulated sterile drug product manufacturing and validation, with a focus on biologics, lyophilization, and fill/finish operations in CMC late-stage development within the biotech/pharmaceutical industry.
Experience in MBRs, EBRs, SOPs, GMP documents review and authoring relevant technical documents and CMC sections for IND/BLA submission.
Strong understanding of cGMP, ICH, USP guidance and standards, and FDA/EMA regulations relating to CMC and manufacturing for biologics.
Proven experience in vendor management for sterile drug products.
Experience with database management systems for scientific data.
Strong leadership skills and a track record of successfully leading teams.
In-depth knowledge of regulatory requirements and quality systems in the biotech/pharmaceutical industry.
Excellent problem-solving abilities and the capacity to drive process improvements.
Outstanding communication (oral, written, and presentation) and interpersonal skills.
Experience with regulatory inspections and audits is a plus.

Director of Regulatory Strategy

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:

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.

Clinical Project Manager / Senior Clinical Project Manager

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:

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.