Larimar Therapeutics

Description: The Company: This publicly held clinical-stage biotechnology company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, nomlabofusp, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. The company has between 60 and 70 employees and has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. The management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, commercialization, and the development of manufacturing processes utilizing good manufacturing practices (GMPs). The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how and expertise to the development of CTI-1601 and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position Summary: The Vice President, Medical will serve as a key leader in shaping and executing all aspects of clinical development within the organization. This executive role is responsible for guiding and supporting clinical research activities, optimizing the safety of study participants and the integrity of clinical data, and representing the Medical leadership in all internal and external interactions. The individual in this role must be able to exercise superior intellectual prowess, judgement, creativity, and flexibility, moving fluidly from providing definitive leadership and direction to cross-functional collaboration with colleagues to performance of everyday tasks. This role will include participation as a member of the company's management team and will require occasional domestic and international travel. Specific responsibilities include: Lead the medical guidance and support of clinical development programs, ensuring prompt, facilitative, and high value collaboration with Clinical Operations and the cross-functional study teams; In coordination with Statistics and Quantitative Sciences, review data and assist with interpretation of data from clinical studies; Partner with Safety and Pharmacovigilance to ensure provision of medical input as needed; Support Medical Affairs activities; Review and approve documents related to the clinical development program; Represent Medical at internal meetings and provide definitive guidance and direction; Supervise direct reports and external contractors; Ensure compliance with relevant regulatory law and guidance; Present medical and scientific information at study site visits and congresses; Represent Larimar Medical in engaging with external partners, regulatory bodies, and other external stakeholders; Perform other duties as appropriate at the direction of the Chief Medical Officer. Requirements: Education, Experience, Skills, and Knowledge: Medical degree (M.D., D.O.) required; neurology or cardiology background preferred; 10+ years of pharmaceutical industry experience with demonstrated progressive increase in management responsibilities; Prior experience in neurology and/or rare disease preferred; Experience with activities related to Medical Affairs a plus but not required; Track record of meaningful and substantial support of Phase 2 and Phase 3 studies, such as medical monitoring activities (data, coding, and protocol deviation review), contribution to and review of documents (protocols, informed consent forms, clinical study reports), and interactions with relevant external stakeholders (key opinion leaders, investigators, data monitoring committee); Proven excellent writing, presentation, communication, leadership, organization, and problem-solving skills; Established understanding of good clinical practices (GCP) and best practices related to evidence generation and scientific communications; Demonstrated appreciation of the needs and culture of a small company environment; Robust knowledge of clinical development, regulatory requirements, and healthcare compliance. Benefits: Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI4f01d5b4b6-

Description: Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to genetic abnormality. The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you! Position Summary: Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions. The Regulatory Affairs Director will be a key member of project teams. The role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: The Director of Regulatory Affairs ex-US will be a key member of project teams to define, develop and lead strategies to maximize global regulatory success towards achievement of program objectives for complex development projects Provide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings Develop internal regulatory procedures and practices Work closely with RA Sr. Director and serve as backup to other global region regulatory activity Requirements: Key Experience, Skills and Knowledge: Minimum of 4-year undergraduate degree 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Can do attitude, flexibility, and mental agility Equal Opportunity Employment We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the employment relationship with all employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI5ddf9fbd83a5-1144

Position Summary The Senior Director, Safety & Pharmacovigilance will provide strategic and operational leadership for Larimar's global drug safety and pharmacovigilance activities across the product lifecycle, from clinical development through commercialization and post-marketing surveillance. This role will have overall responsibility for maintaining, and continuously improving a robust, scalable, and inspection-ready pharmacovigilance system that meets applicable global regulatory requirements and supports the company's clinical, regulatory, and commercial objectives. As the company's senior pharmacovigilance subject matter expert, the Senior Director will provide relevant strategic guidance to executive management and cross-functional teams; oversee safety surveillance, signal detection and evaluation, aggregate safety reporting, safety and pharmacovigilance systems, and pharmacovigilance vendor performance; and ensure appropriate identification, assessment, escalation, and mitigation of emerging safety risks. The successful candidate will be a highly collaborative strategic leader who can operate effectively in a growing biotech environment, build fit-for-purpose capabilities, and translate complex safety information into clear recommendations and decisions for senior leadership. Key Responsibilities: Serve as the senior subject matter expert and strategic leader for safety and pharmacovigilance, executing pharmacovigilance-related and associated tasks in support of multi-disciplinary department activities. Execute and refine the company's global pharmacovigilance strategy in alignment with clinical development, regulatory, medical, quality, and commercial objectives. Maintain and improve a comprehensive, scalable pharmacovigilance system and safety operating model consistent with applicable global laws, regulations, and industry guidance. Support and maintain appropriate safety governance, processes, standards, and procedures to support a compliant, effective, and inspection-ready pharmacovigilance function. Provide day to day oversight of pharmacovigilance vendors and perform review and assessment of individual case safety reports, aggregate safety data, and queries. Lead signal detection, validation, evaluation, and management activities and ensure timely escalation of significant safety findings. Conduct and oversee clinical safety and benefit-risk assessments and recommend appropriate risk mitigation strategies. Partner with Clinical Development, Biostatistics/Statistics, Data Management, Medical, Regulatory, and other functions to ensure integrated evaluation of clinical safety data. Ensure appropriate maintenance and oversight of the clinical safety database and associated safety data processes. Ensure compliance of the global pharmacovigilance system with applicable FDA, EMA, ICH, and other relevant international regulatory requirements and guidance. Provide relevant content for regulatory submissions, agency interactions, and other regulatory activities. Support regulatory inspections and ensure ongoing inspection readiness for pharmacovigilance activities, systems, processes, and vendors. Monitor evolving regulatory requirements and industry standards and proactively assess their impact on the company's safety strategy and operations. Partner with Quality, as appropriate, on vendor qualification, audits, performance management, and issue resolution. Provide safety input into clinical development strategy, protocols, informed consent materials, study plans, and other relevant development activities. Represent Safety & Pharmacovigilance in corporate due diligence activities, including potential acquisitions, licensing opportunities, partnerships, and other strategic transactions. Oversee the development, execution, and maintenance of Safety Data Exchange Agreements and other pharmacovigilance agreements associated with development, licensing, commercialization, and distribution partnerships. Provide strategic safety input into preparation for FDA Advisory Committee meetings and other significant regulatory milestones, as applicable. Foster a culture of proactive risk identification, scientific rigor, regulatory compliance, and patient safety. Perform other duties and strategic initiatives as appropriate to support the company's objectives. Required Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related scientific discipline. 10+ years of progressive experience in pharmacovigilance and drug safety within the biotechnology or pharmaceutical industry. Significant experience leading global pharmacovigilance programs across clinical development and/or post-marketing environments. Demonstrated expertise in safety surveillance, signal detection and management, aggregate safety reporting, benefit-risk assessment, and clinical risk management. Strong knowledge of applicable global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, and other relevant health authorities. Working knowledge of electronic data capture systems and pharmacovigilance software Experience developing, implementing, and maintaining pharmacovigilance systems, processes, and quality standards. Experience managing CROs and other external pharmacovigilance service providers. Demonstrated ability to provide strategic safety advice and influence decisions at the senior leadership level. Experience working effectively in cross-functional teams within a complex, fast-paced biotech or pharmaceutical environment. Strong written, verbal, analytical, organizational, and interpersonal skills. Demonstrated ability to balance strategic leadership with hands-on execution in a growing organization. Preferred Advanced degree (M.S., Pharm.D., M.D., Ph.D., or equivalent) in a relevant scientific or clinical discipline. Experience supporting a product through regulatory approval and into commercialization. Experience establishing or significantly scaling a pharmacovigilance function within a growing biotech organization. Experience supporting FDA Advisory Committee meetings or other significant regulatory milestones. Experience with due diligence, licensing, business development, or strategic partnerships. Experience with combination products, biologics, medical devices, or other complex product modalities. Relevant pharmacovigilance certifications or specialized training. PIfdca976a95f0-3708

Description: The Company: Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia(FA). Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Location: This position is field based with approximately 50-60% travel. Position Overview: The Medical Science Liaison (MSL) is part of the field-based medical affairs teams that plays an important role establishing, cultivating, and maintaining relationships with strategic external stakeholders, specifically key opinion leaders (KOLs) and healthcare professionals (HCPs) in relevant therapeutic areas. The primary responsibilities of the Larimar MSLs will be to provide high quality two-way medical and scientific communication, delivering nonclinical, medical, and pharmacoeconomic information that is consistent and aligns with published and proprietary knowledge of therapeutic areas of interest and Larimar products that are marketed or under development. MSLs will be expected to leverage his or her medical and scientific background, industry knowledge, and business acumen to engage in appropriate, fair and balanced communication with KOLs and HCPs. In addition, MSLs will also provide support for research initiatives, medical education, presentations and publications, congresses, meetings, advisory boards, and other Medical Affairs activities. MSLs may also, from time to time, serve as a subject matter expert for internal stakeholders if appropriate. While MSLs will be expected to operate independently in the field, the execution of day-to-day duties will be an extension of the MSL team, the Medical Affairs function, and the Larimar organization. Larimar MSLs must fit well within Larimar's culture of excellence, collaboration, and respect, and conduct themselves professionally in a manner that is compliant with law, regulation, and Larimar's internal policies. Key Responsibilities: Build and foster scientific relationships with healthcare professionals, investigators, and key opinion leaders including Centers of Excellence In support of the Medical Affairs team, establish goals, objectives, and metrics Participate in and contribute to strategic and tactical discussions regarding Medical Affairs activities Identify relevant thought leaders, professional groups, organizations, decision-makers and other key external stakeholders Engage in scientific exchange with identified key stakeholders Support utilization of tools utilized for key insights, monthly updates, and outcomes driven goals Share and discuss evidence-based scientific data with stakeholders in accordance with all relevant regulatory requirements and company compliance guidance Capture and report scientific insights obtained via appropriate scientific interactions Respond to unsolicited questions regarding pipeline products and Larimar clinical studies and document these requests and responses through appropriate process Participate and support pre-launch medical education within various disease states, product and landscape to internal & external stakeholders as appropriate Collaborate to capture field insights on diagnostic challenges, unmet needs, and standard of care to inform strategy Represent Larimar Medical Affairs at scientific meetings and conferences Contribute to the development of scientific materials Conduct field activities within company policies, industry standards, and compliance as set by regulatory requirements. Requirements: Advanced scientific degree in a relevant clinical/scientific discipline 3-5 years MSL experience in the pharmaceutical or biotechnology industries, with additional experience in rare disease Experience in Neurology, Cardiology, Genetics, and/or rare disease preferred Strong communication and collaboration Prior payer/HEOR experience is a plus Experience working in a clinical or scientific role within the pharmaceutical, healthcare, or medical research industries Thorough understanding of pharmaceutical industry compliance, preferably experience in supporting cross functional teams. Experience using Microsoft Office programs (PowerPoint, Word, Excel, and Outlook) Self-starter who can work effectively within teams Ability to effectively present scientific information to diverse audiences Exemplary interpersonal and communication skills with ability to communicate to a wide variety of audiences Comfortable operating independently and managing unique, unusual, and ambiguous situations by using good judgment and sound decision-making PI9fa1c3de5df0-3705