Senior Director of Project Management

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 t…

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.

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.

Join our dynamic team at 360 IT Professionals as a Senior Project Manager specializing in Quality Management Systems. In this role, you will lead critical projects, ensuring the highest standards of quality and compliance are met. Your expertise will drive continuous improvement initiatives and facilitate effective communication across teams.

We are seeking an innovative and strategic Operations Manager for Special Projects to join our dynamic team at Stripe. This exciting role involves overseeing a variety of special projects that drive operational excellence and promote the growth of our services. You will collaborate with cross-functional teams to identify opportunities for improvement, streamline processes, and implement effective solutions.The ideal candidate will possess exceptional leadership skills, a strong analytical mindset, and a passion for driving results in a fast-paced environment. If you thrive on challenges and have a track record of successful project management, we want to hear from you!

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.

Job Overview:The Clinical Project Manager (PM) is pivotal in steering asset teams towards the successful execution of research, development, medical, and commercial strategies. This role requires the PM to act as the operational leader, ensuring that all cross-functional deliverables are completed on time, within budget, and to the highest quality standards.Key Responsibilities:Lead comprehensive project management efforts for asset teams, aligning with strategic and operational objectives.Oversee asset strategic planning, program execution, resource allocation, and risk management.Manage alliance programs, contributing to budget forecasts and asset valuation assessments.Facilitate regulatory submission processes for initial market authorizations and supplemental applications.Collaborate with cross-functional teams to ensure successful submission preparations and outcomes.Collaboration and Reporting:The PM will report to the PM Group Lead or Senior Director and maintain key relationships with various internal and external stakeholders to support high-functioning asset teams.

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.).

Role overview Flyzipline is hiring a Design Manager / Projects Manager to lead design initiatives that advance logistics and healthcare delivery. Based in South San Francisco, this position manages the full lifecycle of design projects, from initial planning through completion. The role coordinates efforts across departments and ensures projects are delivered on time and within budget. What you will do Manage several design projects at once, maintaining quality and meeting deadlines Collaborate with engineers, designers, and other teams to achieve project objectives Track project budgets and make adjustments to keep projects aligned with financial goals Contribute to Flyzipline’s work in improving on-demand delivery systems Location This position is located in South San Francisco, California.

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.

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.

Join FlyZipline as a Development & Permitting Project Manager, where you will play a pivotal role in advancing our innovative logistics solutions. In this position, you will lead the development and permitting processes for our operational projects, ensuring compliance with regulations while driving efficiency and sustainability.

We are seeking a dynamic and results-driven Project Manager to join our team at Integrated Resources Inc. Located in the heart of South San Francisco, this role offers an exciting opportunity to lead various projects and ensure their successful delivery.As a Project Manager, you will be responsible for planning, executing, and closing projects while managing teams and resources efficiently. You will work closely with stakeholders to define project scope, objectives, and deliverables, ensuring alignment with organizational goals.

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 solutions.We are currently in search of a dynamic and results-oriented Senior Director of Trade Operations. This pivotal leader will be responsible for the vision, design, and execution of U.S. trade and distribution strategies specifically for our dermatology and immunology product lines. This position is essential in establishing efficient and scalable pathways that enhance product accessibility for patients and healthcare providers.Reporting directly to the Senior Vice President of Market Access, the successful candidate will join a dedicated commercialization team focused on impactful results. Ideal applicants will possess a strategic mindset, thrive in fast-paced environments, and have a demonstrated ability to develop and implement strategies while being deeply engaged in the execution process.

About ZiplineAre you ready to make a difference? Zipline is dedicated to revolutionizing the logistics of goods delivery. Our mission is to tackle the world's most pressing access issues by developing and operating the first universal instant delivery service that ensures equitable access for all, regardless of location. We've been pivotal in initiatives from Rwanda's national blood delivery to Ghana's COVID-19 vaccines, and even in Walmart's on-demand home delivery services. Our technology harnesses robotics and autonomy to create a sustainable delivery model, reducing road congestion, fossil fuel dependency, and air pollution while serving billions worldwide.Join Zipline and be part of our commitment to building a fair and resilient global supply chain.About the RoleWe are looking for a Program Manager focused on partner integration to enhance operational efficiency across our retail, restaurant, and healthcare sectors. This role will act as the operational liaison during the implementation of the Zipline Network, ensuring smooth integration with current workflows while optimizing performance for our partners.Your collaboration with Product, Customer Success, Flight Test, and Engineering teams will be crucial in refining and validating our solutions to meet partner expectations. Your expertise in system implementations will play a vital role in defining workflows, ensuring compliance, and facilitating successful integration. Your work will directly influence partner satisfaction and operational success.If you have a passion for system deployment and optimizing workflows, we encourage you to apply.Location: This position is an on-site opportunity based at our South San Francisco, CA headquarters. Relocation support is available!

The OpportunityBecome a pivotal member of Maze Therapeutics as the Director of Data Management. In this influential position, you will formulate and execute the data strategy that underpins our clinical development initiatives. Collaborating extensively with teams in Biostatistics, Statistical Programming, Clinical Operations, and Regulatory Affairs, you will also manage external vendors to ensure the delivery of high-quality, reliable clinical data across our studies.Reporting directly to the Vice President of Biometrics, you will provide strategic guidance and hands-on leadership for clinical data management across various clinical trials. Your contributions will ensure that data is delivered in a timely, compliant, and analysis-ready format, supporting regulatory submissions and critical program decisions.The Impact You’ll HaveLead data management efforts across multiple clinical studies and development phases.Shape and implement data management strategies, standards, and best practices.Mentor and support data management team members, fostering their growth and knowledge sharing.Serve as a subject matter expert for data management processes, systems, and regulatory expectations.Oversee critical study deliverables, including DMPs, CRFs/eCRFs, edit checks, and database locks.Guide accurate, consistent, and timely clinical data collection, cleaning, and reconciliation.Review and approve key study documentation to ensure readiness for analysis and reporting.Drive database lock planning and collaborate closely with Biostatistics and Medical Writing to support analyses and study reports.Manage CROs and external vendors, ensuring clarity regarding timelines, quality expectations, and contractual commitments.Support the evaluation, implementation, and optimization of EDC and data management technologies.Collaborate closely with Clinical Operations, Biostatistics, and other partners across the organization.Provide data management insights for protocols, study design, and operational planning, while proactively communicating risks and mitigation strategies to senior leadership.

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.