Nuvalent, Inc. - Associate Director, Quality Control
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT
Requirements
• BS or equivalent in chemistry or related discipline with 10 – 15 years of relevant industry experience (or MS/PhD with 3 – 5 years of experience) with at least 3 of those years at the QC Senior Manager level or above. • A strong understanding and knowledge of cGMP/ICH regulations and USP Guidelines with the ability to apply them to analytical drug substance and drug product development and manufacturing is required. • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. • Proven ability to lead, mentor, and develop QC staff while driving continuous improvement and phase-appropriate analytical strategies. To influence cross functionally, and make clear, timely decisions. • Knowledge of analytical testing concepts in small-molecule Drug Substance and Drug Product including laboratory controls and good documentation practices. • Ability to author and review relevant documentation (methods, protocols, reports) as well as regulatory sections. • Ability to work with all levels of organization and external contract service providers to ensure compliance with current regulations. • Good understanding of product process and development, from discovery to commercialization • Strong knowledge in CGMP regulations and ICH or other industry guidance. • Proven track record solving analytical and QC challenges with a focus on small molecules. • Proficiency with JMP and application of statistical analysis concepts is preferred. • Additional Information: • Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages. • The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change. • Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.
Responsibilities
• Strategic Pricing Operations • Assist in the development and lead implementation and optimization of pricing strategies for in-line and pipeline oncology products • Managing agenda, preparation and facilitating meetings • Aligning stakeholders and driving strategic input • Documenting decisions and actions • Contracting Execution & Management • Design and manage contracting strategies across key segments: Commercial, Medicare, GPOs, Medicaid, 340B, VA, Payers/PBMs, and IDNs • Manage day-to-day contract execution and issue resolution • Submit new contracts and updates to contract terms • Maintain GPO rosters, updating the 3PL as needed, and prepare quarterly business review (QBR) insights in collaborations with account director teams • Oversee 340B contract pharmacy vendor partnerships • Facilitate and resolve escalations from Patient Assistance Program (PAP) • Data & Insights Collaboration • Monitor competitive pricing intelligence and shifts in market dynamics • Partner with the Commercial Insights & Analytics team to ensure accurate data ingestion, analytics and delivery • Support Finance-led reporting with analytical and operational coordination • Access Optimization • Access Optimization • Partner with Finance, Payer National Accounts, Health Systems Strategic Engagement, Patient Services and Field Reimbursement Managers • Engage with Sales to proactively identify payer policy issues, product formulary status challenges, and denial trends • Support rebate dispute resolution and update internal teams on progress • VA/FSS Contract Administration • Collaborate with Finance and Vendor to facilitate and execute all Requests for Modification (RFM) • Support the 5-year Contract Solicitation and Interim Agreement • Collaborate with Finance and Vendor to complete Public Law 102-585 submission and documentation • Monitor the Tracking Customer and initiate a change if required • Complete the initial registration and annual renewals of SAM.gov • Competencies: • Competencies Include: • Demonstrated passion for improving patient access and outcomes. • Problem-Solving: Proactive approach to resolving complex access issues. • Analytical Skills: Ability to interpret coverage trends & payer policies to identify barriers and implement solution-oriented strategies to optimize patient access. • Business Acumen: In-depth understanding prior authorization, coding, billing, patient services, and specialty pharmacy processes. • Provider Engagement: Building strong relationships with healthcare providers and office Highly responsive; ability to support escalations outside of local time zone working hours, as needed. • Cross-Functional Collaboration: Partnering with sales, market access, patient services, and medical affairs. Foster a culture of empowerment, collaboration, and a focus on patient impact. • Team Leadership: Proven leadership and conflict resolution skills.Encourage collaboration, innovation, and new ideas while integrating information from various sources. • Clear Communication: Highly effective presentation, communication, emotional intelligence, and facilitation & interpersonal skills.Ability to explain complex reimbursement processes in simple terms. • Process Improvement: Identifying opportunities to streamline reimbursement workflows. • Adaptability: Managing evolving payer landscapes and policy changes.
Benefits
• $180,000—$205,000 USD • Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. • Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities. • Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “[email protected]” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person. • If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.
No credit card. Takes 10 seconds.