Director, Regulatory Strategy (Pediatrics) Location: Remote United States Job Description: Who we are: At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate. Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built. The impact you will make: Agios Pharmaceuticals is searching for a dynamic Director, Regulatory Strategy to join our growing Regulatory Strategy team. We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Director, Regulatory Strategy will be responsible for developing regulatory strategies to support pediatric clinical development plans, working cross-functionally across the organization. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities. What you will do: - Develop and execute global regulatory pediatric strategy including the potential to accommodate expedited development needs - Provide global regulatory expertise in support of the development, review, and approval of cross-functionally developed strategies and documents intended to enable clinical trials and marketing authorizations for pediatric programs. - Plan, lead, develop, and review regulatory submissions, such as clinical trial applications, marketing applications, and life-cycle management submissions for pediatric programs. - Plan and lead health authority interactions, as needed, including the development and/or review of associated documents - Engage with Regulatory Authorities on project-related matters - Ensure adherence to current regulations associated with regulatory activities What you bring: - Bachelor's degree in life-sciences or related scientific discipline required; advanced degree (PhD, PharmD, or MS) preferred - 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry - 7+ years of experience with pediatric plans (both in US and EU) - Experience leading preparations for health authority interactions and development of briefing documents - Strong knowledge of drug development, FDA, EMA and ICH guidelines and regulations - Excellent organizational and communication skills, both written and verbal - Ability to work independently as well as part of a team environment - Positive attitude, energetic and proactive - Proven ability to manage multiple projects, identify and resolve regulatory issues - Strong interpersonal skills and the ability to effectively work with others Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening! Work Location: Location Agnostic: Work location for this role is based on employee''s individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.. What we will give you: - Deliberate Development. Your professional growth as one of our top priorities. We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best. - Flexibility. We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best. - Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website. - Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance. - The current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. - Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries. - Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce. - Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked

Title: Associate Director, Pharmacology Location: New York, NY; Boston, MA Job Description: About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others. You can read more at the following links: - Our Vision for AI in Pharma - Our Current Drug Portfolio - Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position Formation Bio is seeking an Associate Director, Pharmacology to join our Development team. In this role, you will help shape and execute pharmacology strategy across development programs, applying broad pharmacology expertise, first-principles scientific thinking, and rigorous translational judgment to advance assets efficiently and credibly. You will contribute to preclinical pharmacology strategy, support drug development and business development activities, and help define the studies and evidence packages needed to make high-quality program decisions. This role is well suited for a scientifically rigorous, intellectually independent pharmacologist who can move fluidly across mechanisms, modalities, disease areas, and stages of development, with particular value placed on familiarity with immunology, animal models, and AI-enabled scientific workflows. The role reports to the Director of Pharmacology and you will be a key member of the Formation Bio Development team. Responsibilities - Execute and contribute to preclinical pharmacology strategy across development programs, with studies primarily executed through CROs - Design, oversee, and interpret pharmacology studies to characterize mechanism of action, target biology, in vivo proof of concept, dose-response, pharmacodynamic activity, exposure-response relationships, and asset progression - Develop integrated pharmacology plans covering efficacy, target engagement, receptor binding, selectivity, biomarkers, PK/PD, translational hypotheses, safety margins, therapeutic index, dose rationale, and key decision points - Apply first-principles scientific reasoning and broad pharmacology perspective to evaluate biological rationale, identify critical assumptions, pressure-test hypotheses, distinguish decision-critical data from interesting findings, and design focused studies to address key scientific, regulatory, or translational questions - Partner with DMPK, Toxicology, Clinical Pharmacology, Clinical Development, Regulatory, CROs, and external partners to integrate pharmacology into development strategy, regulatory materials, in-licensing evaluations, and interactions with regulators, partners, advisors, and internal leadership - Manage CRO-executed pharmacology studies and related workflows, including protocol review, vendor oversight, data quality, timelines, budgets, study conduct, interpretation, final reports, organizational tracking systems, and use of technology, modeling, data analytics, literature mining, and AI-enabled tools to improve speed, rigor, reproducibility, and decision-making About You - PhD in Pharmacology, Biology, Immunology, Translational Sciences, or a related field, with 4-6+ years of relevant post-PhD biopharma industry experience; level will be commensurate with experience - Broad, hands-on expertise in preclinical pharmacology, including mechanism of action, disease biology, in vivo efficacy models, dose-response, target engagement, biomarkers, selectivity, and PK/PD - Strong first-principles scientific judgment, with evidence of original thinking, rigorous hypothesis generation, incisive experimental design, and the ability to interpret complex or ambiguous data - Experience designing, overseeing, and interpreting animal studies, including model selection, endpoint strategy, dosing rationale, exposure-response relationships, and translational limitations - Experience developing pharmacology strategies that support candidate selection, IND-enabling work, clinical development, lifecycle management, regulatory submissions, or externally sourced assets - Strong understanding of how preclinical pharmacology informs translational hypotheses, dose rationale, safety margins, therapeutic index, biomarker strategy, and regulatory positioning; familiarity with immunology, immune-mediated disease biology, or immunomodulatory mechanisms preferred - Experience working cross-functionally with DMPK, Toxicology, Clinical Pharmacology, Clinical Development, Regulatory, CROs, and external partners, including management of CRO-executed studies, protocols, data quality, timelines, budgets, and reports - Highly organized, collaborative, and intellectually curious scientist with excellent communication skills, strong scientific rigor, comfort in fast-paced environments, and enthusiasm for using technology, modeling, data analytics, and AI-enabled approaches to improve pharmacology research and decision-making Compensation Range: $177,500 - $232,000 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate. Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.

Role Description Our client is looking for an experienced Director of Amazon to lead and scale their Amazon business. This is a high-impact leadership role with full ownership of the Amazon channel, including: - P&L management - Marketplace growth - Advertising strategy - Product expansion - Inventory planning - Supply chain coordination - Overall business performance The ideal candidate has a proven track record of growing consumer brands on Amazon, with deep expertise in: - Marketplace operations - Paid advertising - Inventory management - New product launches Beyond driving revenue, you’ll be responsible for: - Improving profitability - Increasing market share - Building scalable processes that support long-term growth This role is best suited for a strategic business leader who can balance big-picture planning with hands-on execution. You’ll work cross-functionally with: - Product - Marketing - Operations - Finance - Executive leadership to identify growth opportunities, optimize performance, and drive measurable business results across the Amazon marketplace. Qualifications - At least 5 years of experience leading Amazon businesses, preferably within the CPG, consumer goods, health, wellness, or related industries. - Demonstrated success owning Amazon P&L and scaling marketplace revenue while improving profitability. - Deep expertise in Amazon Seller Central, Amazon advertising, catalog management, inventory planning, forecasting, and marketplace optimization. - Proven experience launching and scaling new products or expanding product portfolios on Amazon. - Strong understanding of Amazon advertising metrics, profitability analysis, contribution margin, and business performance reporting. - Experience working cross-functionally with marketing, operations, supply chain, finance, and product teams. - Excellent analytical, strategic thinking, and leadership skills with a data-driven approach to decision-making. - Experience managing external agencies or leading high-performing teams is a plus. Requirements - Own the Amazon P&L, driving revenue growth, profitability, and overall marketplace performance. - Develop and execute the company’s Amazon growth strategy with measurable business objectives and KPIs. - Lead Amazon advertising across Sponsored Products, Sponsored Brands, Sponsored Display, DSP, and other relevant advertising channels to maximize return on investment. - Identify opportunities to expand market share through pricing, merchandising, competitive positioning, and catalog optimization. - Oversee the successful launch of new products, bundles, variations, and packaging formats while identifying opportunities for category expansion. - Partner with operations and supply chain teams to improve demand forecasting, inventory planning, and replenishment strategies while minimizing stockouts and excess inventory. - Optimize product listings, A+ Content, Brand Store, promotions, reviews, and customer experience to improve discoverability and conversion rates. - Monitor marketplace trends, competitor activity, and category performance to identify new growth opportunities. - Collaborate closely with product, marketing, finance, creative, operations, and executive leadership to align Amazon initiatives with broader business goals. - Manage external agencies, consultants, and strategic partners when required. Benefits - Competitive annual base salary based on experience. - Performance-based incentives and long-term growth opportunities for exceptional performance. - Fully remote opportunity with a US-based company. - Opportunity to lead and scale a key business channel with significant strategic impact.

• Owns projected clinical improvement savings, AWV completion, and telemedicine adoption outcomes for an assigned partner portfolio • Leads monthly performance reviews, quarterly JOCs, and performance remediation cycles • Holds partners accountable to participation agreement terms and coordinates with Legal and Contract Committee when variance requires escalation • Operates in a dyad model with the assigned Quality Improvement Nurse (QIN) • Operates as a strategic advisor across clinical partner groups and post-acute facility systems • Translates CCLF claims data, QEXPU quality files, quality registry outputs, and utilization reporting into partner-specific insight • Coordinates across Clinical (CMO, QINs), Telemedicine, Business Development, Legal, Revenue Cycle, and Operations to resolve partner needs and execute performance plans