Description:
About Us:
Larimar Therapeutics Inc. 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 Summary:
Job Title: Associate Director, Clinical Operations
This position reports to the Vice President, Clinical Operations and will be responsible for the execution and reporting of global clinical trial activities, ensuring adherence to study timelines, budgets, quality plans, and relevant ICH/GCP Guidelines.
Responsibilities:
Will include but are not limited to:
- Writes and/or reviews protocols, protocol amendments, informed consent forms, annual reports, and submission documents.
- Participates in the development of outsourcing strategies, including the evaluation and selection of CRO's and vendors.
- Manages/monitors global clinical study activities and execution by the CRO's/vendors through adherence to study timelines and established metrics.
- Participates in the review and/or generation of all relevant study documents, tools, plans, guidelines, and specifications, including but not limited to EDC, monitoring plans, study management and oversight plans, IWRS specifications, etc.
- Understands and tracks study monitoring/management metrics and understands core concepts of Risk Based Monitoring.
- Development and management of clinical trial finances including study budgets, service contracts, investigator grants, accruals, and forecasting.
- Accountable for ensuring that all studies are carried out according to the study protocol, SOPs and applicable ICH/GCP guidelines.
- Participates in inspection readiness activities and audit activities; works with the quality department to ensure that all corrective and preventative actions are implemented.
- Participates in quality and process improvement initiatives as necessary.
Requirements:
Education, Experience, Skills and Knowledge:
Requires a B.A./B.S. in life sciences or healthcare (advanced degree preferred) and a minimum of 7 years of relevant drug development experience in the pharmaceutical/biotechnology industry. Experience in clinical trials (Phase 1 through 3) required, with experience in rare diseases, oncology, or neuroscience drug development preferred. The successful candidate will have the ability to partner with Patient Advocacy Groups and thorough knowledge of ICH/GCP guidelines, clinical trial design, and regulatory processes. If you have demonstrated vendor and project management experience and are able to apply analytical and problem-solving skills in the identification of emerging risks and to collaboratively champion solutions, this may be the opportunity for you.
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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