Senior Director of Trade Operations

At Alumis Inc., we are at the forefront of precision medicine, dedicated to revolutionizing the lives of individuals suffering from autoimmune diseases. Despite significant advancements in treatment over the past two decades, many patients continue to experience hardships. Our mission is to fundamentally transform patient outcomes through innovative solution…

Join Alector as the Senior Director of CMC Technical Operations, where you will lead innovative efforts in the development of siRNA therapeutics. This pivotal role involves overseeing the entire lifecycle of CMC activities, ensuring regulatory compliance, and driving the strategic direction of our product pipeline. Your expertise will be instrumental in collaborating with cross-functional teams to advance our mission of harnessing the power of RNA therapeutics.

Lead and strategize all CMC regulatory initiatives to ensure adherence to global regulatory standards for the development of ORIC's innovative products.Deliver CMC regulatory support for both new and ongoing clinical trials, including the management and preparation of CMC documentation for INDs, CTAs, and amendments submitted to global regulatory agencies (RAs) and health authorities (HAs).Collaborate effectively with teams in Pharmaceutical Development, Drug Substance, GMP Quality Assurance, Project Management, Clinical Operations, Clinical Supply, and Regulatory Operations.Oversee the preparation and responses for CMC-related meetings with global RAs and HAs, aligning regulatory obligations with corporate goals.Stay updated with global CMC regulations and proactively identify and assess regulatory risks, formulating mitigation strategies.Plan, supervise, and manage all CMC components of regulatory submissions, including strategies for updating existing dossiers and submitting new INDs, CTAs, NDAs, MAAs, and more.Assess proposed manufacturing modifications for their global impact on existing filings and provide strategic regulatory guidance for effective implementation.Offer hands-on assistance in generating CMC documentation (e.g., Module 2 and Module 3 of eCTD, IMPD, etc.).

Join Maze Therapeutics as a Senior Director of Pharmaceutical Development, where you will lead innovative projects aimed at transforming the lives of patients. In this pivotal role, you will drive the strategy and execution of our pharmaceutical development initiatives, collaborating closely with cross-functional teams to advance our pipeline of therapies.

At Alumis Inc., we are dedicated to revolutionizing treatment for patients suffering from autoimmune diseases through precision medicine. Despite the advancements in treatment over the past twenty years, numerous patients with immunologic conditions still experience challenges. Our ambition is to fundamentally alter the outcomes for these individuals.We are on the lookout for a dynamic and results-driven Senior Director to strategically shape and implement our U.S. market access strategy for a late-stage immunology asset focused on dermatology. This pivotal role, reporting to the Senior Vice President of Market Access, is tailored for an individual who flourishes in a streamlined environment, takes initiative beyond their title, and propels strategy through effective execution.As a vital member of our compact senior team, you will be expected to deliver significant impact without the extensive infrastructure typical of larger organizations. This position is ideally suited for professionals who have thrived in complex dermatology markets and are eager to evaluate challenges, pinpoint viable solutions, make decisive choices, and work efficiently.

About Xaira Therapeutics Xaira Therapeutics is a biotech startup based in the San Francisco Bay Area, with offices in Seattle and London. The company develops generative AI models to advance drug discovery, focusing on protein and antibody therapeutics. By building foundational models for biology and disease, Xaira aims to uncover new therapies and improve the chances of success in drug development, especially for targets that have been difficult to address in the past. Role Overview The Senior Director of Project Management leads the execution of complex scientific and platform projects at Xaira. This position works closely with teams in biology, computational science, protein design, and engineering to keep projects moving forward with clear goals and strong alignment. The role translates high-level strategy into defined projects, setting out scope, milestones, responsibilities, and dependencies. What You Will Do Guide cross-functional teams through large-scale scientific and technical projects Collaborate to clarify objectives, ensure alignment, and maintain momentum Break down strategic priorities into actionable project plans Define project scope, milestones, ownership, and dependencies Help teams prioritize based on impact and set clear outcomes Bring structure to complex workflows while supporting fast-paced discovery work What We Look For Extensive project management experience, ideally in a scientific or technical setting Ability to work across scientific, technical, and organizational boundaries Comfort translating strategy into detailed project execution Strong organizational skills and a product-focused mindset Experience empowering teams to work efficiently in research-driven environments Location: South San Francisco, California, United States

Alumis Inc. is at the forefront of precision medicine, dedicated to revolutionizing the lives of individuals suffering from autoimmune diseases. Despite advancements in treatment over the past two decades, many patients with immunological disorders continue to endure challenges—our mission is to fundamentally improve their outcomes.We are in search of a seasoned Senior Medical Director of Clinical Development to oversee a broad spectrum of rheumatology and autoimmune clinical drug development, ranging from discovery research to first-in-human, proof-of-concept, and Phase 3 studies. This pivotal role will lead multiple studies within our portfolio and collaborate closely with the cross-functional asset team to leverage comprehensive clinical expertise and successfully enhance clinical programs and overall asset strategies.Key Responsibilities:Act as the physician lead for LUMUS, a Phase 2b clinical trial with 388 patients aimed at assessing the efficacy, safety, and pharmacokinetics of ESK-001 in adults with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).Lead in-stream data reviews and reconciliation processes.Author critical clinical documents, including Protocol Amendments and Regulatory Submissions.Oversee the LUMUS medical monitor and engage in external scientific collaborations, including peer interactions with physicians.Represent Alumis broadly as a leader, driving corporate initiatives across the rheumatology domain.Inspire, manage, and coach team members to achieve their objectives through a focused and collaborative approach.Uphold the highest standards of integrity and scientific inquiry in drug development.Initial Goals:Establish trust and respect with key internal and external stakeholders, building a reputation as a strategic and productive partner.Deliver hands-on leadership, contributing expertise, and collaborating effectively with the operations team to ensure the success of LUMUS.Enhance and maintain the quality of study data, particularly regarding the main efficacy endpoints.

About Kardigan Kardigan focuses on heart health, working to shift cardiovascular disease from a global threat to a manageable condition. The company develops multiple targeted therapies at once, aiming to provide effective treatments for people living with cardiovascular diseases. Kardigan was founded by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D. The team previously led MyoKardia, where they developed mavacamten, the first cardiac myosin inhibitor. Their work led to MyoKardia's acquisition by Bristol Myers Squibb in 2020. The company uses advanced discovery and translational research platforms and has a pipeline of late-stage candidates. The team is committed to improving patient outcomes. Our Values Prioritize the well-being of patients and their families Embrace authenticity and foster inclusion Encourage learning, curiosity, and adaptability Support each other in striving for excellence Work together to achieve ambitious goals for patients These values shape daily work at Kardigan and support a lasting impact in the field of cardiovascular health.

Role Overview Cellares is seeking a Senior Operational Technology Engineer in South San Francisco, CA. This role focuses on strengthening and improving operational technology systems across the company. What You Will Do Work closely with teams from different departments to improve operational systems. Apply technical knowledge to boost the efficiency and reliability of technology supporting operations. Help identify and implement solutions that improve overall performance and support operational goals.

Join Our Vision at insitroinsitro is on the hunt for a dynamic Senior Director of External Research & Development to spearhead all facets of our external R&D portfolio. This pivotal leadership role is accountable for crafting and executing the company’s external R&D strategy, defining and optimizing our collaborations with preclinical and research contract research organizations (CROs).In this strategic capacity, you will work closely with senior leaders across diverse functions, including Research, Drug Discovery, Technical Operations, Corporate Development & Strategy, Finance, and Project Management, ensuring a seamless approach to alliance and outsourcing management.Reporting directly to the Chief Technical Operations Officer, this position welcomes both remote and local candidates, offering flexibility to work onsite (3 days per week) at our South San Francisco office or a hybrid model (~1 week per month) with some travel (up to 25%) to oversee partnerships both domestically and internationally.Key ResponsibilitiesExternal R&D Strategy: Drive a comprehensive external research strategy, aligning with corporate objectives and supporting the research portfolio. Represent insitro in senior-level partnership discussions and negotiations, ensuring effective management of business partnerships.Partner Network Management: Cultivate and oversee innovative relationships with a strategic network of high-quality CROs and external partners, maintaining the highest scientific and ethical standards.Project Execution & Oversight: Ensure the successful planning, monitoring, and execution of externally sourced projects across the vendor network, adhering to project goals, budgets, and timelines. Foster strong communication and partnership with internal stakeholders.Governance & Compliance: Develop effective governance models and collaborate with Legal and Procurement on partner selection, negotiations, and agreement execution.Process & Team Leadership: Lead a team to implement industry-leading processes in vendor management, ensuring compliance with contractual obligations and standard operating procedures (SOPs).Operational Review & Improvement: Regularly assess the overall scope of outsourced services to ensure resource efficiency and effectiveness.

The OpportunityThe remarkable integration of multi-modal data, advanced disease modeling, and cutting-edge computational capabilities is transforming the landscape of drug discovery. At insitro, we are seizing this pivotal moment to revolutionize the development of treatments for complex diseases. Our AI and machine learning-driven platforms are designed to integrate and scale data swiftly, enabling the discovery of novel biological insights that redefine complex diseases and pinpoint new therapeutic targets and drugs.To realize this ambitious vision, we are in search of a Senior Director of Project & Portfolio Management (PPM) who will spearhead the creation of an AI-centric PPM organization. This role will collaborate closely with Therapeutic Area, Operations, Clinical, and Business Development teams to advance a high-impact portfolio of innovative drug candidates targeting neurological, ophthalmological, and metabolic conditions.Reporting to the Chief Scientific Officer, you will work alongside project team leaders to formulate tailored project strategies and cultivate a high-performance team environment that promotes rapid advancement. You will be responsible for developing and executing comprehensive integrated project plans with clearly defined timelines across research, discovery, clinical development, software engineering, and data science/machine learning. As the head of PPM, you will also collaborate with colleagues in Compute, Operations, and Finance to establish sophisticated AI-driven project management, decision-making, and resource allocation methodologies to support critical initiatives.This position is hybrid, requiring three days per week on-site at our South San Francisco headquarters.

Kardigan is dedicated to transforming heart health by developing treatments aimed at preventing and curing cardiovascular disease. The company’s mission is to end cardiovascular disease as the world’s leading cause of death. Multiple targeted therapies are in development, with a focus on delivering effective solutions for people affected by cardiovascular conditions. Kardigan’s leadership includes Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D. This team previously led MyoKardia, where their work resulted in the discovery of mavacamten, the first cardiac myosin inhibitor, and culminated in MyoKardia’s acquisition by Bristol Myers Squibb in 2020. With a modern research platform and a strong pipeline of late-stage candidates, Kardigan is positioned to improve outcomes for patients living with heart disease. Values Patient-centric: Every decision prioritizes patients and their families. Authenticity: The culture encourages acceptance and values each individual. Curiosity: Ongoing learning and openness to new perspectives are encouraged. Team success: Collaboration, urgency, and shared achievement are essential for results. Enable the impossible: Innovation and thoughtful risk-taking drive scientific advancement. These values shape daily work and support Kardigan’s efforts to make a lasting difference in heart health.

About Us: Calico Life Sciences LLC, a pioneering research and development entity backed by Alphabet, is dedicated to advancing the understanding of human aging through innovative technologies and modeling systems. Our mission is to leverage this knowledge to develop interventions that enhance health span, enabling individuals to live longer, healthier lives. With a commitment to curiosity-driven scientific discovery and collaborative partnerships in drug development, Calico offers an inspiring environment to foster significant medical breakthroughs. Position Overview: As a Medical Director/Senior Medical Director at Calico, you will report directly to the Head of Clinical Sciences. Your primary focus will be on providing strategic insights into the translational and clinical development of projects aimed at enhancing human health span through a better understanding of aging and age-related diseases, with a specific emphasis on neurologic and neuropsychiatric conditions. Key Responsibilities: Lead cross-functional teams to translate preclinical mechanistic data to clinical applications and develop translational biomarkers for innovative targets in neurologic and neuropsychiatric fields. Collaborate with research and drug development leaders both within and outside Calico to refine disease indication strategies for new targets. Utilize clinical expertise to guide the creation and application of preclinical models in partnership with discovery and biomarker scientists. Work closely with various drug development teams to shape new clinical programs throughout their lifecycle, particularly focusing on translational and early clinical development phases (Phase 0 through Phase 2). Design and implement experimental medicine studies to validate the mechanism of action for novel targets in neuropsychiatric disorders. Formulate and execute early clinical development strategies to establish proof of concept across various neuropsychiatric indications. Contribute scientific and medical knowledge for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions, and other vital documents.

At Structure Therapeutics, we are dedicated to developing transformative medicines for patients utilizing cutting-edge structure-based and computational drug discovery technologies. Our innovative platform merges the latest breakthroughs in molecular interaction visualization, computational chemistry, and data integration to create superior oral small molecule medicines that address the limitations of current biologic and peptide drugs. We are actively progressing a clinical-stage pipeline of unique treatments targeting chronic diseases with significant unmet needs, particularly in cardiovascular, metabolic, and pulmonary health.Our leadership team consists of renowned international drug innovators, supported by top-tier global life sciences investors. Having completed our IPO in February 2023, we operate offices in California and Shanghai, leveraging the strengths of both regions to be at the forefront of life science innovation.

Twist Bioscience is on the lookout for a strategic and innovative leader to spearhead our global marketing organization, shape our brand narrative, and foster sustainable growth across all business units. The Vice President/Senior Director of Global Marketing will report directly to the SVP of Product and Marketing, taking charge of establishing the global marketing vision, strategy, and its execution across various markets and regions. This pivotal role involves converting business objectives into impactful marketing strategies, managing brand and product positioning, orchestrating integrated global campaigns, driving growth marketing initiatives, leveraging digital channels, and enhancing executive-level customer engagement. Key Responsibilities: Lead Twist's global marketing efforts, encompassing global marketing programs, regional marketing, events, digital marketing, customer advocacy, creative design, and marketing operations. Define and take ownership of the overall global marketing strategy, aligning it with corporate objectives, product roadmap, and long-term market opportunities. Act as the executive leader for the global marketing function, nurturing and mentoring a top-tier team of marketing professionals while promoting a culture of innovation, accountability, and data-driven excellence. Translate market and customer needs into a cohesive program strategy, collaborating with executive leaders and diverse teams worldwide to solidify our strategic direction. Oversee the creation of high-quality thought-leadership content (including publications, blogs, white papers, and case studies), establishing Twist as a recognized authority in NGS applications, DNA Synthesis, and Protein Solutions. Formulate a comprehensive global event strategy, ensuring alignment with regional sales goals across AMER, EMEA, and APAC. Manage a multi-million dollar global marketing budget, ensuring strategic resource allocation and maximizing return on investment (ROI) across all channels. Direct the development and assessment of all global, integrated marketing programs and campaigns to achieve measurable customer acquisition and revenue growth across sales channels, including eCommerce. Work closely with Sales and other executive teams to develop integrated Go-to-Market (GTM) strategies and optimize lead generation and conversion globally. Establish and communicate executive-level Key Performance Indicators (KPIs) and metrics to the senior leadership team and Board of Directors, showcasing marketing’s impact on company growth. Define the global product marketing strategy and execution plan to enhance market penetration and customer engagement.

At Alumis Inc., we are dedicated to revolutionizing the lives of patients afflicted with autoimmune diseases through precision medicine. Despite advancements in treatment over the last 20 years, a significant number of individuals with immunologic conditions continue to endure hardships; our mission is to fundamentally alter these patients' outcomes.We are in search of a highly skilled Senior Clinical Development Medical Director to lead various aspects of our dermatology and autoimmune clinical drug development initiatives, encompassing discovery research, first-in-human trials, proof of concept, and Phase 3 studies. This role will include overseeing one or more studies within our portfolio and collaborating with all cross-functional team members to leverage comprehensive clinical knowledge in successfully advancing clinical programs and the overall asset strategy.

Join Alumis Inc., a pioneering precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Despite substantial advancements in treatment over the past two decades, many individuals with immunologic conditions continue to face challenges. Our mission is to fundamentally improve outcomes for these patients.The Senior Manager of Pharmacovigilance (PV) Safety Operations will report to the Director of PV Safety Operations. This pivotal position is essential for ensuring the timely reporting, processing, and submission of Individual Case Safety Reports (ICSRs) originating from ongoing clinical trials and post-marketing studies. The role encompasses oversight of case processing vendors, management of the ICSR process, collaboration with cross-functional teams during study execution, and support for inspection readiness activities, all while ensuring strict compliance with regulatory requirements.

About UsAt insitro, we are at the cutting edge of integrating machine learning into drug development, aiming to uncover clinically actionable insights that address significant unmet patient needs. Our mission is to expedite and enhance the drug development journey, ensuring a seamless transition from platform to pipeline and ultimately to patients.The RoleWe are seeking a (Senior) Director, Project Team Lead (PTL), also referred to as Asset Team Lead (ATL), to spearhead clinical development initiatives. This pivotal role involves leading cross-functional drug development teams from the nomination of preclinical development candidates through Phase 1 and Phase 2 clinical trials, including proof-of-mechanism (POM) and proof-of-concept (POC) studies. The PTL will be responsible for the comprehensive integration of the therapeutic molecule strategy, timeline management, and risk mitigation efforts.Our commitment is to enhance the clinical trial experience for both patients and drug developers. By prioritizing patient needs, we strive to improve the overall drug development process.In this role, you will design and implement innovative, accelerated strategies, leveraging insitro's machine learning capabilities to achieve excellence in drug development and clinical trials.You will report directly to the Chief Scientific Officer, with opportunities for either onsite work (3 days per week) at our South San Francisco office or a hybrid model (approximately 1 week per month). Some travel may be required to engage with relevant medical and health authorities.This is an outstanding opportunity for an experienced PTL who is eager to leverage their expertise in accelerating the drug development process and delivering better therapeutic options to patients in need.

About Us Kardigan is a pioneering company dedicated to transforming heart health by making cardiovascular diseases preventable and curable, striving to eliminate it as the leading cause of death globally.Our mission is to develop multiple targeted therapies in parallel, ensuring that individuals suffering from cardiovascular diseases have access to the cures they deserve. Founded by renowned experts Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan is backed by a legacy of success from their work at MyoKardia, where they played pivotal roles in the discovery and development of mavacamten, the first cardiac myosin inhibitor, which led to its acquisition by Bristol Myers Squibb in 2020. We boast an advanced discovery and translational research platform, a robust pipeline of late-stage candidates, and an exceptional team committed to enhancing patient lives. At Kardigan, our values shape our interactions and drive our success. We are patient-focused, prioritizing the needs of patients and their families. Our commitment to authenticity fosters an inclusive environment where everyone is valued. With an eagerness to learn, we encourage curiosity and adaptability. We believe in team success, striving for excellence, and supporting each other in our roles. Finally, we aim to enable the impossible, embracing risks to spur innovation and advance scientific breakthroughs. These guiding principles empower us to make a tangible difference every day.

Xaira Therapeutics develops protein and antibody therapeutics using generative AI models, with the goal of targeting difficult molecular challenges in drug discovery. The company’s foundation models support better identification of drug targets and patient groups, aiming to improve the success rate of new therapies. Xaira is headquartered in the San Francisco Bay Area, with offices in Seattle and London. Role overview The Senior Director of Supply Chain and Strategic Sourcing leads supply chain, procurement, and contract governance across Xaira. This position is responsible for ensuring reliable access to external partners, platforms, and services that support teams in Research, Biomedical AI, Platform Engineering, and Corporate operations. What you will do Build and implement a sourcing strategy that supports Xaira’s mission and growth plans Strengthen vendor management and relationships with key suppliers and service providers Develop and oversee a contract governance framework Maintain operational continuity with external partners Transform procurement and contracts into a unified, scalable supply chain function Focus areas This leadership role sits at the intersection of research, technology infrastructure, and external partnerships. The Senior Director will align sourcing, vendor, and contract decisions with Xaira’s long-term goals.