Vice President Of Pharmacovigilance

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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. Their 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 a genetic abnormality.

The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has about 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 and expertise to the development of nomlabofusp and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

Position Purpose and Description:

The Vice President of Pharmacovigilance (PV) will be responsible for the global, strategic, and operational oversight of the quality and compliance of pharmacovigilance, drug safety, and clinical risk management activities in support of Larimar worldwide and in fulfillment of global legislation and regulations.

Reports to: Chief Medical Officer

Primary Responsibilities:

• As the established senior subject matter expert, advise relevant stakeholders in matters pertaining to safety and pharmacovigilance

• Design, develop, and implement a pharmacovigilance system in conformance with global regulatory law and guidance

• In collaboration with Statistics and Quantitative Sciences, develop and maintain a comprehensive clinical safety database

• Monitor clinical safety data, identify potential safety signals, perform risk assessments, and take appropriate action to ensure patient safety

• Inform company leadership regarding potential safety signals and advise appropriate actions

• Support submissions to regulatory regarding safety reporting

• Oversee management of global safety and pharmacovigilance systems, including maintenance of business aspect of the systems; identify need for system upgrades or alternative technologies to meet business needs and to ensure compliance and scalability and recommend and implement a course of action to address these needs

• Identify and manage vendors for all outsourced safety and pharmacovigilance activities

• Ensure functional representation of safety and pharmacovigilance as a member of relevant project teams

• Represent pharmacovigilance for due diligence activities; oversee development, execution and maintenance of Safety Data Exchange Agreements for all development, licensing, commercialization, and distribution partnerships to meet regulatory requirements and protect assets

• Participate in strategy and content for FDA Advisory Committee for new indication for an FDA approved product

• Optimize department organization, resources, processes and plans in accordance with the corporate strategy and business needs

• Perform other duties related to safety and pharmacovigilance as directed by the Chief Medical Officer

Requirements

Required

• Bachelor's Degree

• 12-15 years of experience in pharmacovigilance in biotech/pharma companies

• Expertise in investigational and post marketing safety and pharmacovigilance programs for drugs, biologics devices and combination products

Preferred

• Master's Degree and/or trainings/certifications in a relevant area

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.