Scientific writer Jobs in Philadelphia, PA

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.

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