Head, GCP/GLP Quality Assurance_

Boston

Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview

The Head, GCP Quality Assurance provides strategic leadership and direction for clinical quality assurance operations and other prioritized needs, ensuring Rhythm’s drug development programs comply with regulatory standards and driving continuous improvement of Good Clinical Practices (GCPs). The role collaborates with cross functional leaders and stakeholders to develop, implement, and leads global quality strategies that align with Rhythm’s goals and objectives, setting the overall vision and long-term priorities for the Clinical Quality Assurance organization.  This role reports into the SVP, Global Regulatory Affairs and GCP/GLP QA.

Responsibilities and Duties

+ Lead the clinical quality function ensuring compliance with applicable regulations, industry standards, and company polices across tactical and strategic initiatives.

+ Drive a culture of continuous improvement by identifying areas for enhancement, implementing process improvements, and promoting best practices to enhance an overall culture of quality, efficiency, and compliance.

+ Drive the strategic planning process for the Clinical Quality Assurance organization through ongoing assessment of regulatory, industry, technological, and internal trends/best practices, determining impact to the business.

+ Develop strategies to identify and mitigate related risks across clinical activities.

+ Establish and maintain robust clinical quality standards. Develop and implement standard operating procedures (SOPs), quality manuals, and other related quality documents.

+ Develop and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical programs. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.

+ Consult and partner with the clinical program team to provide compliance guidance across investigator sites, vendors, and internal processes. Lead regulatory inspections, ensuring preparedness and appropriate responses to findings and observations.

+ Provide leadership and oversight for training programs related to clinical quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.

+ Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical quality assurance activities.  Prepare regular reports and presentations for executive management highlighting quality performance, trends, and areas for improvement.

+ Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities. Build and maintain effective relationships with internal and external stakeholders.

+ Lead, develop, and mentor the clinical quality assurance team, responsible for the execution and sustainability of GCP across the portfolio. Set clear expectations, manage performance, and foster a positive collaborative working environment for a diverse team.  Develop talent and build a skilled motivated team.

Qualifications and Skills

+ Bachelor's degree required, preferably in Nursing, Pharmacy, Public Health or other biological/medical science degree combined with equivalent technical experience.

+ 12+ years industry experience in any combination of pharmaceutical, device, combo/device, research, development, clinical research, quality systems, or a combination of those or comparable experiences.

+ Thorough understanding of global and local clinical trial/study regulatory requirements and processes.

+ 5+ years’ leadership experience and exemplary tactics in motivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive information and situations.

+ 5+ years’ people management experience in motivating and developing high-performing teams (direct and indirect reports) with challenging goals that foster growth, learning and engagement.

+ Excellent communication skills, including superior negotiation and influencing skills. Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference. Ability to manage difficult conversations and seek alignment and target messages to key stakeholders effectively.

+ Ability to be hands on and direct and coach all aspects of work projects (strategic and tactical) effectively.

+ Comfortable prioritizing and balancing multiple tasks simultaneously within evolving and at times, rapidly changing priorities and deadlines.

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.

More about Rhythm

Our lead asset, IMCIVREE® (setmelanotide), is a precision medicine designed to treat hyperphagia, an insatiable, pathological hunger characterized by abnormal food-seeking behaviors, and early- or rapid-onset severe obesity caused by an impairment of a pathway in the hypothalamus called the melanocortin-4 receptor (MC4R) pathway. IMCIVREE® is the first and only approved therapy for certain rare MC4R pathway diseases in the United States, Europe, Great Britain and several other countries. In collaboration with leading experts across the world, Rhythm is advancing the most comprehensive clinical research program ever initiated in MC4R pathway diseases, including a Phase 3 trial for acquired hypothalamic obesity. In addition, we are leveraging our extensive genetic database, global network of researchers, a track record of regulatory successes and global commercial infrastructure to develop a full portfolio of treatment options to patients struggling with hyperphagia and severe obesity and ensuring they get the treatment that is right for them.

We continue to advance care and precision medicines that address rare diseases. We are focused on expanding access to IMCIVREE® to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.

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