Rezolute

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI). The Senior Medical Science Liaison (Sr.MSL) will join a newly developed Medical Affairs Department. Sr.MSLs are responsible for developing and enhancing professional relationships with medical thought leaders within the metabolic and oncologic space. MSLs provide medical information through scientific exchange, and clinical/scientific support for Rezolute and the Medical Affairs department. This is a work position requires professionals with established personal and scientific credibility to interact with global thought leaders and academic centers of excellence. Essential Functions KOL Development and Field Engagement: - Identify and develop peer-to-peer relationships with key opinion leaders (KOLs) and healthcare providers within relevant Metabolic and Oncology therapeutic areas - Identify new, up and coming thought leaders within target therapeutic areas - Develop and execute projects and program material in alignment with evolving launch readiness plans - Identify and communicate key clinical and research issues and insights from KOLs to appropriate departments - Participate in medical education for healthcare professionals (HCPs) through virtual/on-site presentations at healthcare institutions, investigator meetings, national/international conferences, advisory boards, or regional meetings - Provide scientific support for additional activities such as medical congress staffing, advisory boards, and internal and external training initiatives Positions self as Scientific Expert - Maintains an up to date and high-level knowledge of the therapy area, Rezolute products, new and emerging areas of research, therapeutic issues and trends, and competitive landscape. - Establishes reputation as a trustworthy and knowledgeable source of scientific and medical information for the healthcare community. - Supports development of Rezolute positioning as the scientific authority in Metabolism & Oncology therapeutic space. Attends appropriate scientific congresses to stay abreast of developments and to support International, National, Regional and local KOL activities and Rezolute interests. - Acquires a broad understanding of local, national and international protocols and standards of clinical practice and trends in disease management. - Provide clinical presentations and information in response to unsolicited questions (as appropriate) in academic, community, and healthcare provider settings in both group and one-on-one situations - Communicates emerging data and the clinical experience with our products through scientific exchange and peer-to-peer interactions discussing benefits and risks in an objective manner. - Provide support for data generation activities (company-sponsored studies, collaboration studies, ISTs and Rezolute’s Expanded Access Program) - Provide scientific support for additional activities such as medical congress staffing, advisory boards, and sales training initiatives Medical Affairs Planning and Plan Execution - Contributes to the development of the launch readiness plans and provides input into strategies and tactics. - Where needed, manages relevant budget to enable execution of Medical Affairs tactics as part of the wider launch readiness team. - Works in a collaborative manner with cross-functional colleagues to meet defined strategic imperatives and critical success factors. - Interacts with HCPs as a scientific resource to support activities aligned with launch readiness plans including advisory boards, speaker development, publication plans and clinical trials, as appropriate. Evidence Generation and Life Cycle Management: Strategic development and execution of data generation plans to support pipeline assets. - Collaborate cross-functionally with Clinical Development, Medical Affairs, Regulatory, and HEOR teams to align data strategies. - Identify, assess, and prioritize data gaps across the product lifecycle in alignment with clinical, medical, and future commercial objectives. - Facilitate advisory boards and expert consultations to validate data gaps and ensure scientific and clinical relevance. - Help in the development of key processes/SOPs that delineate the IIST/RWE process from proposal and protocol to contracting and publication. - Leverage KOL insights, congress findings, and emerging literature to refine evidence generation strategies. - Align data activities with regulatory submission requirements, payer evidence needs, and competitive differentiation strategies. - Monitor competitive landscape and scientific trends to proactively adjust product strategies and sustain market differentiation. Responsible for maintaining Company standards and values - Consistently acts to enhance Rezolute’s image as an advocate of medical advancement by using knowledge of product, disease state and pipeline products to engage healthcare providers in meaningful scientific exchange of information. - Document and forward reports of adverse events and product complaints according to Rezolute's policy to ensure safe and effective use of Rezolute’s products. - Adheres to the relevant international, national and local Codes of Practice. - Behaves ethically and with integrity at all times. - Acts as an ambassador for Rezolute following company mission and values. - Keeps own written development plan and implements. - Prepares timely reporting according to the company needs. Required Knowledge, Skills, and Abilities - Ability to research, critically analyze and communicate complex scientific/medical information and data. - Clear and concise communication and presentation skills. - Excellent planning and organization skills, with high-level attention to detail and accuracy. - Strong strategic mindset. - Highly self-motivated and ability to work autonomously. - Ability to learn quickly, be flexible and results-focused in a rapidly changing environment. - Demonstrated skills in inter-personal relationship building, networking, collaboration and teamwork. - Strong capabilities working with Microsoft suite of products and other digital platforms and tools are required - Excellent command of spoken and written English. - Ability and willingness to travel. Driving may be required. - Knowledge of healthcare environment and external experts in academia and medical community. - Demonstrated ability to develop trust and relationships with opinion leaders in disease states of interest. - Understanding of regulatory requirements for field-based personnel - Experience as a Medical Science Liaison with a strong track record of success is strongly preferred Required Education and Licenses - Advanced medical, clinical, nursing or similar degree (such as MD, PhD, PharmD, NP, PA or equivalent) - A minimum of 5 years' experience as a MSL or comparable industry or clinical role is required, with a minimum of 2 years’ experience in rare disease. - This position will require field activities, and applicants must be willing to travel 60-75% time - Valid driver's license and live within 60 miles of an airport services by at least one major airline. Description of Physical Demands - Frequent travel (domestic and international) with potential extended time away from home. - Frequently operating a computer, printer, telephone and other similar office machinery. - Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands. - Frequent public contact requiring appropriate business apparel. Preferred Experience, Special Skills and Knowledge - We are looking for a candidate that has: - Strong leadership skills and ability to effectively communicate up, down and across the organization - Ability to effectively prioritize and deliver high-quality results on tight timelines - Excellent written, verbal communication and presentation skills - Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues - Act with HONOR: Honesty, Open with Direct Communication, Nimbleness, Open-minded, Respect Rezolute (RZLT) currently anticipates the base salary for the Senior Medical Science Liaison role could range from $170,000 to $220,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate. Qualifying employees are eligible to participate in benefit programs such as: · Health Insurance (Medical / Dental / Vision) · Disability, Life & Long-Term Care Insurance · Holiday Pay · Tracking Free Vacation Program · 401(k) Plan Match · Educational Assistance Benefit · Fitness Center Reimbursement We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.

Company Description Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI). Rezolute has received orphan drug designation in the United States and European Union as well as a rare pediatric disease designation, for ersodetug, enabling eligibility for a priority review voucher. More information can be found at rezolutebio.com Position Description Overview: The Manager, Quality Assurance at Rezolute is a dedicated Quality professional responsible for managing GxP quality requirements supporting product development, phase appropriate and proportionate lifecycle management of clinical products, and the commercialization, launch, and ongoing commercial supply of ersodetug. The Manager, Quality Assurance is a hands-on core member of the Quality team and plays a critical role across the product lifecycle from clinical development through post approval commercialization. In partnership with other functional areas (including MSAT, Supply Chain, R&D, Regulatory Affairs, Pharmacovigilance, Sales, and Marketing), the Manager, Quality Assurance will develop and execute quality deliverables supporting CMC and commercial strategies, including the identification, assessment, and escalation of quality and compliance risks. This includes, but is not limited to, partnering with CMC and Commercial Operations to ensure that product is manufactured, released, distributed, promoted, and monitored in compliance with internal standards and applicable global regulatory requirements. The Manager, Quality Assurance is a key contributor within Rezolute’s Quality organization and supports Quality Assurance processes for clinical stage programs, validation and qualification of commercial processes, product disposition, and post approval lifecycle management. This role also provides quality oversight for commercial activities, including support of sales and marketing materials, vendor and distributor oversight, product complaints investigations, and regulatory agency commitments following product approval. Principle Duties and Responsibilities: - Review and approval of Master Production Records from Contract Manufacturing Organizations to include Drug Substance manufacturing, Drug Product manufacturing, Finished Drug Product labeling and packaging operations, and External Laboratory Oversight. - Review of executed records and final Product Disposition of product intended for supply of clinical trials, extended access programs, and commercial supply. - Provides the Quality oversight to ensure product is manufactured, tested, stored, and distributed according to cGMPs and other applicable regulations. - Responsible for ensuring drug substance, drug product, and finished drug product, is dispositioned to meet Rezolute’s timelines, including labeling and packaging records. Interacts with CMOs and Qualified Persons to ensure timely release of product in ex-US territories - Attends, participates in, and contributes to CMC team meetings - Reviews and/or approves methods, procedures, master records, executed records, reports and protocols employed in the conduct of cGMP activities - Authors new or revisions to quality systems SOPs and work instructions to support quality functional activities. - Reviews and approves production batch records, certificates of analysis, client notifications, specifications, qualifications, investigations, deviations, CAPA, certificates of origin, and certificates of conformance - Provide Quality assessments and approvals for Change Controls impacting clinical or commercial products, processes, labeling, or distribution. - Provide Quality review/approval of clinical and commercial Labeling & Artwork - Provides technical quality and/or strategic support to sites during product service provider qualification audits, pre-approval inspections, and routine GMP inspections as required. - Support post approval commitments, variations, and lifecycle management activities in collaboration with QA Compliance, Regulatory Affairs and CMC. - Support Continuous Process Verification/Validation and ongoing commercial process monitoring activities. - Contribute to inspection readiness activities and responses to regulatory agency questions, commitments, and post‑marketing requirements. Qualifications/Requirements: Minimum of Bachelor’s degree in a scientific discipline with five to seven years’ experience in a cGMP regulated pharmaceutical/biotech environment - Strong knowledge of appropriate Quality Systems and cGMPs (FDA, EU, ICH) with the ability to assess compliance risks - Demonstrated ability to work independently and remotely, prioritize, problem-solve and complete activities in a timely manner without daily direction from the Head of Quality or others. - Strong verbal skills, technical writing skills and ability to work with others in a collaborative manner. - Ability to anticipate and mitigate challenges and apply a flexible risk-based approach to problem solving - Experience with Microsoft Office is preferred Preferred Experience, Special Skills and Knowledge - - Expertise and hands-on knowledge of GMPs - Entrepreneurial, innovative, analytical, and solution-minded - Proficiency in SharePoint, MS-Word, Excel, PowerPoint, Adobe Acrobat, and Veeva Rezolute (RZLT) currently anticipates the base salary for the Manager Quality Assurance ole could range from $140,000 to $165,000 and will depend in part on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate. Qualifying employees are eligible to participate in benefit programs such as: - Health Insurance (Medical / Dental / Vision) - Disability, Life & Long-Term Care Insurance - Holiday Pay - Tracking Free Vacation Program - 401(k) Plan Match - Educational Assistance Benefit - Fitness Center Reimbursement We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.