Director, Medical

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

Director, Medical

Position Summary

The Director, Medical, will fulfill a meaningful leadership role, providing medical input and oversight regarding all aspects of the clinical development program. As a key contributor in a multi-disciplinary team, the Director will ensure that the safety of study participants and the scientific integrity of clinical studies are maintained. The Director will represent the company’s medical function and collaborate with internal and external stakeholders as a key scientific and medical resource. Specific responsibilities include:

• As an integral member of a cross-functional team, provide day-to-day support for clinical development activities;
• Participate in study team, safety, data review, protocol deviation, and other relevant meetings;
• Contribute to the development of clinical study designs and analysis plans;
• Review study protocols and amendments, applicable study plans, informed consent forms, investigator brochure updates, clinical study reports, regulatory submissions, and other relevant documents;
• In coordination with Pharmacovigilance and Product Safety, review safety data from clinical studies and conduct follow up inquiries as needed;
• Supervise the medical monitors for the company’s clinical studies;
• Communicate with external advisors, key opinion leaders, study investigators, and patient advocacy group representatives to facilitate meaningful exchange of scientific and medical information;
• In coordination with Statistics and Quantitative Sciences, review data and assist with interpretation of data from clinical studies;
• Ensure compliance with ethical, legal, and regulatory guidelines for all medical activities;
• 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
• Minimum 3 years of pharmaceutical/biologics industry experience in interventional clinical trial research; 5-7 years of experience preferred
• Proven background and experience in clinical drug development
• Prior experience in neurology, pediatric, and/or rare disease a plus, but not required
• Ability to lead technical and business discussions internally and externally and explain scientific/medical concepts to all levels
• Ability to cultivate and maintain relationships with leading medical and scientific experts in the relevant fields
• Strong knowledge of clinical trial design, regulatory requirements, and healthcare compliance.
• Exemplary writing, presentation, communication, and problem-solving skills
• Flexibility and adaptability to adjust to changing priorities and deadlines

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.