Senior/Executive Medical Director, Clinical Development (New Indications)

At Alumis Inc., we are dedicated to revolutionizing the treatment of autoimmune diseases through precision medicine. Despite advancements in treatment over the past two decades, many patients with immunologic conditions still experience significant challenges. Our mission is to fundamentally improve outcomes for these patients.Position SummaryWe are actively…

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 AbbVie as the Executive Medical Director for Immunology Clinical Development, focusing on Respiratory and Pulmonary health. In this pivotal role, you will lead innovative clinical strategies and ensure the successful development of therapies that will transform patient care.

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 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.

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 AbbVie as a Scientific Director / Medical Director in the field of Medical Affairs focusing on Oncology, specifically targeting Ovarian Solid Tumor. In this pivotal role, you will lead strategic initiatives and research efforts aimed at improving patient outcomes through innovative therapies. Collaborate with cross-functional teams to develop and implement comprehensive medical strategies that align with our commitment to advancing oncology care.

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, founded by Alphabet, is at the forefront of research and development, dedicated to unraveling the complexities of human aging through cutting-edge technologies and innovative model systems. Our mission is to leverage this understanding to create interventions that empower individuals to enjoy longer and healthier lives. With a dynamic drug-development pipeline, fueled by curiosity-driven discovery science and collaboration with academic and industry partners, Calico is a vibrant hub for catalyzing medical breakthroughs. Role Overview: We are looking for an experienced Associate Director of Medical Writing who will lead and oversee the creation and review of high-quality clinical and regulatory documents, ensuring compliance with relevant guidelines and regulations. The ideal candidate will excel in cross-functional collaboration, engaging effectively with various stakeholders while fostering a positive team dynamic. This role demands strong project management and technical leadership skills, accompanied by a focus on scientific excellence. Key Responsibilities: Document Leadership and Authoring: Lead medical writing efforts for clinical programs. Serve as a subject matter expert in medical writing, collaborating with the Clinical Science team to produce essential clinical documents such as study protocols, informed consent forms, clinical study reports, and regulatory submissions. Work closely with the regulatory team to ensure timely and high-quality completion of regulatory documents required for submissions, including health authority meeting requests and briefing packages. Vendor Management: Guide external writers in prioritizing tasks, developing content, and managing timelines to support clinical and regulatory activities. Process Improvement: Establish best practices for medical writing, including standard timelines and templates. Collaborate with the Quality Assurance team to create and update Standard Operating Procedures for medical writing processes to ensure compliance with ICH requirements.

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. Despite significant advancements in treatment over the last two decades, many individuals facing immunologic conditions still experience challenges. Our mission is to fundamentally alter the outcomes for these patients.We are currently seeking a Clinical Quality Assurance Director (Contractor) to join our team, reporting directly to the Executive Director of GCPQA. This pivotal role involves collaborating with Quality leadership and Study Execution Team members to provide expertise in ICH-GCP/GVP for our ongoing clinical studies. The position requires close interaction with Clinical Operations, Clinical Development, Clinical Supply Chain, Data Management, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and various other departments across Alumis.The Clinical QA Director is tasked with ensuring that quality is integrated throughout the entire lifecycle of our clinical programs through comprehensive oversight, evaluation, and monitoring. This includes utilizing risk assessment tools, conducting audits, and implementing risk mitigation strategies. The Director will also play a key role in establishing Key Performance Indicators and Metrics to track the health of our clinical trials.This position entails providing operational quality guidance for development teams and supporting the Executive Director of GCP Quality in shaping the strategy and vision for the Alumis Quality organization.The ideal candidate will possess extensive knowledge of Good Clinical and Pharmacovigilance Practices (ICH-GCP & GVP) along with relevant US and EU regulations. We seek a proactive leader who will champion a culture of ethics, integrity, and quality management. Your guidance will be vital in ensuring that our quality functions meet the rigorous standards set by global regulatory authorities.ESSENTIAL DUTIES & RESPONSIBILITIESEstablish and maintain ICH-GCP Clinical QA programs, policies, and procedures.Ensure compliance of ongoing clinical programs with health authority regulations, guidelines, and internal Standard Operating Procedures.Serve as the primary ICH-GCP Clinical QA expert and point of contact for all related matters and initiatives.Create and maintain study-specific audit plans; conduct audits and lead external quality auditors as necessary.Represent the Quality team on project teams, during Health Authority Inspections, and in operational meetings with service providers and CROs.Provide quality oversight and review of critical Clinical and IND/NDA enabling documents.Review clinical trial documentation to ensure data integrity and compliance.

About AKASAAt AKASA, we are on a mission to revolutionize the healthcare sector through the power of artificial intelligence. As pioneers of generative AI solutions tailored for the healthcare revenue cycle, our goal is to assist health systems in effectively capturing and conveying the comprehensive clinical journey of patients. By streamlining operations, we enable healthcare providers to concentrate on their primary objective—delivering exceptional patient care. Our innovative approach has garnered over $205 million in funding from prestigious investors like Andreessen Horowitz, BOND, and Costanoa Ventures.This is an exhilarating time to join AKASA, as revenue bookings for our new AI-native product suite have surged over 20 times since its launch in 2024. We have consistently shattered records, achieving the largest deal in our company's history three times in a row. This remarkable growth is fueled by the significant enhancements we are providing our customers in clinical quality and documentation accuracy—key priorities for health system leaders.Our deployments have gained national recognition as "one of the most comprehensive real-world applications of GenAI in healthcare finance to date" (link). Our clientele represents over $120 billion in net patient revenue and includes some of the most innovative health systems across the nation, such as Cleveland Clinic, Duke, Stanford, and Johns Hopkins.Recent accolades include being recognized as the #1 most promising healthcare RCM startup of 2025 by Black Book Market Research and one of the fastest-growing GenAI startups to watch by AIM Research. Our CEO has been honored as one of the “Top 50 Healthcare Technology CEOs” by the Healthcare Technology Report, and for five consecutive years, we have been certified as a “Great Place to Work.”We are harnessing this momentum to redefine the possibilities within healthcare and are seeking exceptional individuals to help us accelerate this vision.About the RoleAs a Senior Product Manager, you will be responsible for overseeing one of AKASA's flagship products within our Clinical Documentation and Medical Coding suite.This suite enhances physician documentation quality, aids clinicians in identifying overlooked diagnoses, transforms documentation into medical codes, and ensures financial accuracy, thereby improving the overall efficiency of healthcare delivery.

About Us: Calico Life Sciences LLC, founded by Alphabet, is a pioneering research and development organization dedicated to leveraging cutting-edge technologies and innovative model systems. Our goal is to deepen our understanding of the biological processes governing human aging. By harnessing this knowledge, we aim to create interventions that empower individuals to enjoy longer, healthier lives. With our state-of-the-art technology labs and a dedicated commitment to curiosity-driven scientific exploration, alongside vibrant collaborations with academic and industry partners, we are at the forefront of groundbreaking medical advancements. Position Overview: The Associate Director of Clinical Science will play a crucial role in the strategic planning and implementation of translational and clinical development protocols across multiple therapeutic areas, aligning with Calico's mission to enhance human healthspan by exploring aging and age-related conditions. The ideal candidate will lead the development of innovative clinical strategies for designated programs, fostering a positive and collaborative team atmosphere. Key Responsibilities: Collaborate with the Head of Clinical Science and Medical Directors to lead or represent the Clinical Science function in cross-functional teams focused on executing clinical development plans that translate preclinical data into human studies targeting novel aging-related therapies. Draft and refine clinical sections of protocols from Phase 0 to Phase 2, working closely with interdisciplinary teams including Research, Biomarkers, Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Biometrics, Pharmacovigilance, Toxicology, and Medical Writing. Contribute to the design and execution of experimental medicine studies aimed at demonstrating proof-of-mechanism for innovative targets in aging and related diseases. Engage with academic investigators to support the execution of Investigator-initiated trials. Review and contribute to critical study documents, such as Investigational Brochures, Clinical Study Reports, Statistical Analysis Plans, and IND/CTAs. Provide training to CROs and study site personnel on assigned protocols, addressing queries as they arise. Participate in the assessment and selection of CROs and study vendors.

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.

At Alumis Inc., we are dedicated to revolutionizing the lives of patients battling autoimmune diseases. Despite advancements in treatment over the past two decades, many individuals with immunologic conditions continue to face significant challenges. Our mission is to transform their outcomes fundamentally.The Director of Data Systems (DS) and Clinical Programming (CP) will spearhead the Clinical Programming function within Data Management (DM). This pivotal role reports directly to the VP of Data Management and Clinical Programming.Key Responsibilities: Lead and oversee the Data Systems and Clinical Programming function within DM.Drive the adoption of innovative technology solutions to enhance DM processes, boost efficiency, and improve overall data quality assurance.Take charge of AI-related initiatives within DM.Formulate and execute strategies to optimize data flow, database constructions, and the integration of external technologies.Supervise the validation of the EDC platform, ensuring continuous system optimization.Manage relationships with key external vendors, aligning their efforts with organizational objectives.Guarantee compliance with pertinent data privacy regulations while safeguarding clinical trial data.Ensure timely completion of DS & CP project deliverables, adhering to quality standards and regulatory requirements.Collaborate with cross-functional teams to synchronize data strategy with broader organizational goals.Mentor and develop team members, fostering a culture of continuous learning and professional growth.Oversee all SAS clinical programming requests, standardizing the clinical programming specification development process.Develop and maintain Alumis’ standard CRFs and standard edit checks, including indication-specific standards.Create DS & CP SOPs and Work Instructions.Lead the development and maintenance of standard vendor Data Transfer Agreements (DTAs).Guide the execution of technical initiatives within DM, including the rollout of critical data visualizations and dashboards such as Clean Patient Tracking and data currency.Integrate data analytics within DM to continually enhance current processes.

At Alumis Inc., we are passionate about revolutionizing the treatment landscape for individuals suffering from autoimmune diseases. Our commitment to precision medicine drives us to innovate treatments that significantly enhance patient outcomes, addressing the unmet needs of those living with immunologic conditions.We are currently in search of an experienced Associate Director of Biostatistics to lend their statistical acumen and operational support to both early-stage and late-stage clinical programs. This pivotal role will see you acting as the lead statistician for various studies, collaborating with multidisciplinary teams to facilitate clinical development and informed decision-making through data analysis. You will play an active role in critical deliverables, oversee CRO activities, and mentor junior team members, fostering a culture of excellence within our statistical team.

Kardigan seeks a Vice President of Clinical Development for Tonlamarsen (TLA), based either in South San Francisco, CA or Princeton, NJ. This position reports directly to the Chief Medical Officer and is part of the Development department. The role is on-site four days a week, Monday through Thursday. Role overview This leadership position focuses on guiding the clinical development of Tonlamarsen (TLA), a key candidate in Kardigan’s late-stage pipeline. The Vice President will play a central role in advancing targeted therapies for cardiovascular disease, supporting Kardigan’s mission to transform heart health and improve patient outcomes. Work environment The role is embedded in a team known for its track record in cardiovascular drug development, including leadership with experience from MyoKardia and the successful development of mavacamten. Collaboration, urgency, and a patient-centered approach shape daily work. The company values authenticity, curiosity, and team success, aiming to achieve significant impact for patients with cardiovascular conditions. Location and schedule South San Francisco, California or Princeton, New Jersey On-site presence required Monday through Thursday

Join Oric Pharmaceuticals as a Senior Medical Science Liaison for the Eastern Region, where you will play a pivotal role in advancing our medical initiatives and fostering relationships with key opinion leaders. In this dynamic position, you will leverage your expertise to communicate scientific information and provide support to our clinical programs. Ideal candidates will have a robust background in medical affairs and a passion for making a difference in patient care.

Join Oric Pharmaceuticals as a Senior Medical Science Liaison in the Western Region, where you will play a pivotal role in advancing our mission to innovate cancer therapies. As a key member of our Medical Affairs team, you will collaborate with healthcare professionals and stakeholders to communicate the scientific value of our products.

About Us&nbsp;Kardigan is at the forefront of heart health innovation, dedicated to making cardiovascular diseases preventable and treatable, transforming them from the leading global cause of death.Our mission is to develop multiple targeted therapies that simultaneously address cardiovascular conditions, bringing patients the cures they deserve.&nbsp;Founded by industry leaders including Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., who previously spearheaded MyoKardia and the discovery of mavacamten, Kardigan combines a cutting-edge research platform with a robust pipeline of late-stage candidates, all aimed at improving patient outcomes.&nbsp;Our values—patient-driven, authentic, eager to learn, team-oriented, and innovative—guide our interactions and efforts to make a real difference in the lives of those affected by heart disease.&nbsp;We are inspired by the potential to enable the impossible, ensuring that our work is impactful every day.&nbsp;Reports To:&nbsp;&nbsp; VP, BiometricsLocation: </strong>Princeton, NJ – On-site 4 days per week (Mon to Thurs)&nbsp;Position SummaryThe Head of Data Analytics is a strategic leader responsible for the architectural vision and operational execution of data delivery and advanced insights at Kardigan...