Senior Director, Medical Affairs

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. 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 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.

Position:

Senior Director, Medical Affairs

Reports to: Chief Medical Officer

Job Responsibilities:

Position Overview:

The senior director, Medical Affairs, contributes to the development of the Medical Affairs strategy, in collaboration with the chief medical officer (CMO) and key internal stakeholders, and oversees the tactical execution of Medical Affairs activities. As a key aspect of this role, the senior director, Medical Affairs represents Larimar and specifically the CMO when interacting with external stakeholders such as health care providers, scientists, third party payors, patient advocacy organizations, and patients and their families to provide relevant medical and scientific information in a manner that is wholly compliant with applicable laws and regulations. Initially, the senior director, Medical Affairs will be expected to spend a significant amount of time in the field in advance of directing the recruitment, training, and deployment of a medical science liaison (MSL) team.

In addition to overseeing and directly contributing to field-based external interactions, the senior director, Medical Affairs is responsible for the development of Medical Affairs functions, direction of internal and external Medical Affairs resources, and management of internal cross-functional collaboration involving Medical Affairs projects as well as supporting Larimar initiatives as appropriate. Accordingly, the individual in this role must consistently demonstrate exemplary leadership, communication, collaboration, and mastery of the relevant medical and scientific information.

Key Responsibilities:

• •Develop and lead the Medical Affairs strategy and design the evolving structure necessary to support Medical Affairs functions such as medical information, medical communications, and congress and publication planning across the continuum of pre-, peri-, and post-product launch;
• •Build, train, and deploy an MSL team and develop the systems needed to support MSL field activities and manage the two-way flow of information;
• •Design and implement a key opinion leader (KOL) outreach program that will establish and maintain strong relationships with relevant key opinion leaders, academic institutions, and medical societies through both direct participation as well as the activities of the MSL team;
• •Manage the relationship between Larimar and patient advocacy organizations, serve as the lead point of contact, and ensure appropriate presence at relevant patient advocacy organization events and delivery patient-focused educational content;
• •Contribute to publication and congress planning and manage internal and external stakeholders supporting publication and congress activities;
• •Facilitate communication of medical and scientific information to support market access interactions;
• •Establish policies and procedures for key medical affairs activities and partner with Legal and Regulatory Affairs to ensure Medical Affairs activities are conducted according to Larimar’s policies and procedures and in a manner compliant with all external laws and regulations;
• •Collaborate with internal stakeholders to ensure timely development of externally facing materials that are accurate and compliant with applicable law, regulation, and guidance;
• •Provide medical and scientific training to internal and external stakeholders as appropriate;
• •Other duties as assigned by the CMO.

Requirements

Qualifications:

• •Education: Degree in life sciences with either significant clinical experience or a relevant advanced degree (MSN, PhD, PharmD, MD/DO)
• •Experience: At least 7-10 years of Medical Affairs experience that includes prior experience working in a rare disease therapeutic area, pre-, peri-, and post-launch experience, and a demonstrated track record of successfully building and leading a Medical Affairs function
• •Attributes: Proven ability to operate in a small company environment with an enthusiasm for “building it from the ground up” and a strong drive to “get it done”

Note: This position may be headquarters-based or field-based but will require approximately 50% travel on average as well as regular presence at company headquarters.

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.