Associate Director, Clinical Scientist

Position Summary: Celcuity is on the lookout for an experienced Associate Director, Clinical Scientist, who will play a pivotal role in driving our Clinical Development initiatives. Reporting directly to the Executive Director of Clinical Science, you will collaborate closely with Medical Directors and other key personnel in the Clinical Development department. Your expertise will be crucial as you represent the Clinical Science group in various multidisciplinary teams and forums, all while working with a moderate level of supervision. Key Responsibilities: Conduct thorough reviews of clinical data to guarantee quality and consistency in clinical site reporting. Draft and evaluate Clinical Development documents, ensuring high-quality standards in writing, reviewing, and resolving cross-functional feedback. This includes abstracts, manuscripts, clinical protocols/amendments, informed consent forms, regulatory documents, and more. Create and assess presentations and training materials, including slide decks and posters. Engage in Clinical Development Core Team and Clinical Sub-Team meetings as necessary. Collaborate with Biostatistics, Data Management, Clinical Operations, Project Management, Quality Assurance, Regulatory Affairs, and other project team members. Act as a representative for Clinical Science in operational meetings, such as Study Management Team meetings. Continually enhance your scientific and clinical knowledge in relevant therapeutic areas.

Company Overview Fulcrum Therapeutics is an innovative clinical-stage biopharmaceutical organization dedicated to enhancing the quality of life for patients suffering from genetically defined rare diseases that exhibit a significant unmet medical need. Our proprietary product engine is adept at identifying drug targets capable of modulating gene expression to address the underlying causes of gene misexpression. We are currently advancing our flagship asset, FTX-6058 (pociredir), a small molecule engineered to elevate fetal hemoglobin expression for the treatment of sickle cell disease and beta thalassemia. Position Summary The Associate Director of Clinical Science will collaborate closely with the Executive Medical Director and VP of Clinical Development to provide critical support across one or more Clinical Project Teams at Fulcrum Therapeutics. This role is pivotal in ensuring the effective design and execution of Clinical Development Plans, focusing on crafting cost-efficient clinical trials that fulfill the needs of both internal and external stakeholders. The successful candidate will assume responsibility for the scientific oversight of clinical studies, working in partnership with study program leadership and cross-functional team members. This includes the interpretation and communication of clinical trial data, which are crucial for high-quality regulatory submissions. Key responsibilities encompass contributing to the design and execution of company-sponsored clinical trials at all developmental phases, analyzing clinical trial data, and facilitating internal and external communications regarding project plans and progress. The Associate Director will also be involved in safety monitoring and mitigation strategies, as well as making significant contributions to regulatory submissions, publications, and communications of clinical data.

This remote role reports directly to the Chief Medical Officer. Key Responsibilities:Individual ResponsibilitiesCollaborate with a cross-functional team to execute Clinical Development Plans and Registrational Strategies for assigned products.Work closely with Clinical Development teams and Clinical Research Organizations (CROs) to create and maintain high-quality clinical trial documentation, including Protocols, Investigator Brochures, and Clinical Study Reports, ensuring compliance with ICH/GCP standards and relevant regulations.Support the management of clinical trial data collection, review, and analysis according to statistical analysis plans.Monitor and evaluate clinical data for trends in safety and efficacy and adherence to protocols.Assist in preparing clinical documents for submission to global health authorities, including briefing materials for EMA Scientific Advice and IND submissions.

Join Our Mission Revolutionizing Clinical Trials at Lindus Health. We are committed to accelerating the development of new treatments through innovative and efficient clinical trials. In a landscape where outdated practices lead to increased costs and delays, we are reshaping the future of drug development to ensure patients gain access to life-saving therapies more swiftly than ever.Our achievements speak volumes: Since March 2021, we've successfully facilitated over 100 clinical trials, involving tens of thousands of patients. Recently, we secured a $55 million Series B funding round from Balderton Capital, with additional support from Creandum, Firstminute, Seedcamp, and Visionaries. What You Can Expect When You Join UsAt Lindus Health, you will engage in:Impactful Work with a Purpose: Engage in transformative projects that directly enhance patient outcomes and demonstrate the real-world impact of your contributions.Dynamic Environment with Ownership: We value results and dedication, allowing you to take on significant responsibilities and influence the trajectory of our success.Collaborative Culture: Join a team of bright, motivated individuals in a relaxed environment where creativity thrives, and teamwork is celebrated.Are you ready to be part of this transformative journey? We would love to hear from you. About the RoleWe are seeking an experienced Associate Director of Clinical Operations to take on a pivotal leadership role, combining oversight of clinical portfolios with commercial management responsibilities. This position merges operational expertise with commercial insight, ensuring the success of clinical trials from both operational and business perspectives.In this role, you will manage 3-5 active trials while leading a team of 3-5 Project Leads and Project Associates. You will provide guidance on resourcing, timeline management, and strategic direction, while also managing commercial aspects within defined SOW parameters. Building and maintaining strong sponsor relationships is key, along with facilitating the transition of projects from Business Development to Clinical Operations, providing operational insights that enhance the sales process.As a subject matter expert in Clinical Operations and a vital contributor to our culture, you will influence our working practices...

About Us Kardigan is a pioneering heart health company dedicated to transforming cardiovascular disease from a leading global health threat to a manageable condition. We strive to innovate and develop effective treatments that can prevent and cure heart diseases.Our mission is to create multiple targeted therapies simultaneously, ensuring that individuals suffering from cardiovascular conditions have access to the treatments they deserve. Founded by industry leaders Tassos Giannakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s leadership has a proven track record, having previously led MyoKardia to successfully develop mavacamten, the first cardiac myosin inhibitor, culminating in its acquisition by Bristol Myers Squibb in 2020. With a state-of-the-art research platform, a robust pipeline of late-stage candidates, and an exceptional team, we are devoted to enhancing patient outcomes. At Kardigan, our values shape our operational ethos. We are profoundly patient-centric, prioritizing the needs of patients and their families. Authenticity is at our core; we foster an environment where everyone feels accepted and valued. Our eagerness to learn fuels our curiosity and adaptability. We emphasize teamwork, urgency, excellence, and shared accountability, and we are committed to enabling groundbreaking innovations to transform lives. These principles empower us to make a meaningful impact each day. Position Title: Associate Director, Clinical OutsourcingDepartment: Development Business OperationsReports To: Director, Development Business OperationsLocation: South San Francisco, CA (preferred) or Princeton, NJ – On-site 4 days per week (Mon to Thurs)

Definium Therapeutics, previously known as Mind Medicine, is a pioneering biopharmaceutical company in the clinical stage, focusing on innovative product candidates aimed at addressing brain health disorders. Our commitment is to lead globally in developing and delivering transformative treatments that enhance patient outcomes. We are advancing a promising pipeline of unique product candidates, targeting critical neurotransmitter pathways involved in brain health, with and without acute perceptual effects.Since our establishment in 2019, we have been on a trajectory of growth, continuously expanding our global presence. We seek dynamic and impactful professionals across various domains in clinical, technical, and business operations to enrich our team of intelligent, patient-focused individuals.The Associate Director of Clinical Development will be instrumental in designing and executing both ongoing and new clinical studies. This role acts as the clinical science representative for multiple clinical studies (both US-based and global) to ensure the delivery of high-quality data for registration. Collaboration with Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Early Development, Medical Affairs, Commercial teams, and other stakeholders is essential for the successful delivery of clinical programs aimed at registration and market launch. The Associate Director will serve as the clinical science lead to Contract Research Organizations (CROs) and other vendors.

Role Overview Acadia Pharmaceuticals is hiring an Associate Director of Clinical Operations. This position is based in either Princeton, New Jersey or San Diego, California. The Associate Director will guide key phases of clinical trials, focusing on high-quality execution and adherence to regulatory requirements. What You Will Do Lead and oversee essential stages of clinical trial operations Ensure all activities meet regulatory and company standards Promote effective collaboration across multiple teams Drive project timelines to support company objectives Take a hands-on approach to managing clinical operations

Join Revolution Medicines, Inc. as an Associate Director of Clinical Operations, where you will play a pivotal role in advancing the development of innovative therapies. This leadership position will involve overseeing clinical trial management, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to drive project success.

Nuvalent seeks an Associate Director of Clinical Operations to join the team in Cambridge, MA or work remotely. This leadership role guides the execution of clinical trials, ensuring every step aligns with regulatory standards and internal protocols. The position partners with cross-functional teams to develop and deliver on clinical strategies, overseeing studies from planning through closeout. What you will do Direct clinical trial operations for multiple concurrent studies Maintain compliance with all regulatory requirements and company procedures Work closely with colleagues across departments to create and implement clinical strategies Supervise all aspects of study management, from initiation to completion Oversee budgets, timelines, and resource planning for clinical programs Mentor and guide junior staff within clinical operations Requirements Significant experience in clinical operations and project management Background working in pharmaceutical or biotechnology organizations Demonstrated ability to manage budgets and timelines Experience mentoring or managing team members

Role Overview AbbVie Inc. is hiring an Associate Director of Clinical Pharmacology in North Chicago. This position leads pharmacological strategy across the drug development pipeline, working closely with teams from multiple disciplines. The Associate Director plays a key role in optimizing clinical trial design and improving drug efficacy. What You Will Do Guide pharmacological strategy for drug development programs Collaborate with cross-functional teams to refine clinical trial designs Apply expertise to improve drug efficacy and patient outcomes Contribute to research that advances patient care

EyePoint Pharmaceuticals seeks a Director of Clinical Science to join the team in a fully remote capacity. Reporting to the Chief Medical Officer, this leader will help shape clinical development and work across departments to advance the company’s product portfolio. Key Responsibilities Work with internal teams to implement Clinical Development Plans and Registrational Strategies for assigned products. Collaborate with Clinical Development and Clinical Research Organizations (CROs) to ensure clinical trial documentation meets ICH and GCP guidelines. This includes Clinical Research Protocols, Investigator Brochures, and Clinical Study Reports. Support the collection, review, and analysis of clinical trial data, ensuring consistency with statistical analysis plans. Monitor ongoing clinical data to identify trends in safety and efficacy across studies. Prepare clinical documents for global health authority submissions and regulatory meetings. Contribute to meeting abstracts and publications that share clinical trial results. Oversee site initiation activities, including the development and execution of monitoring plans. Assist with recruitment strategies and collaborate with sites to achieve enrollment targets. Maintain compliance with global regulatory authority requirements throughout clinical trial execution. Work Location This position is fully remote.

Role overview The Associate Director, Aesthetics Clinical Development at AbbVie Inc. in Irvine provides leadership for clinical research projects in the aesthetics space. This position shapes product development strategies and ensures that regulatory standards are met at every stage. What you will do Direct clinical research initiatives for aesthetic products, guiding studies from concept through execution. Establish strategic priorities for development programs and maintain compliance with regulatory requirements. Refine research methodologies to promote reliable, high-quality outcomes. Collaborate with cross-functional teams to improve patient outcomes and contribute to advancements in aesthetic medicine.

Role Overview Centria Autism is hiring an Associate Director of Clinical Services in Arizona. This role leads clinical teams focused on delivering high-quality care to individuals with autism. Key Responsibilities Oversee the implementation of clinical programs and ensure they meet established care standards. Maintain adherence to best practices throughout all clinical operations. Guide and support clinical staff, encouraging collaboration and professional growth. Drive ongoing improvement of clinical services through feedback and evaluation. Develop and execute strategic plans that support Centria Autism’s mission to improve lives. What Success Looks Like Clinical teams feel supported and motivated. Programs consistently meet or exceed quality benchmarks. Strategic initiatives contribute to measurable enhancements in care.

Join 4D Molecular Therapeutics as the Associate Director of Clinical Supply, where you will play a pivotal role in the management and optimization of our clinical supply chain. This position requires a strategic thinker with a solid background in clinical supply logistics, ensuring timely delivery of materials for clinical trials.

Join 4D Molecular Therapeutics as an Associate Director of Clinical Operations and play a pivotal role in leading innovative clinical trials that pave the way for groundbreaking therapeutic approaches. This position is fully remote, allowing you to collaborate with a dynamic team dedicated to advancing gene therapy solutions.

AbbVie is seeking a passionate and innovative Associate Director of Aesthetics Clinical Development to lead our clinical initiatives in the aesthetics sector. This pivotal role involves overseeing clinical trials, collaborating with cross-functional teams, and driving strategic advancements in our aesthetic product pipeline. The ideal candidate will have a strong background in clinical development, exceptional leadership skills, and a commitment to enhancing patient outcomes.

We are seeking an experienced and dynamic Associate Director of Clinical Operations to join our team at Revolution Medicines. In this pivotal role, you will lead the planning, execution, and management of clinical trials, ensuring alignment with regulatory guidelines and company objectives. You will work closely with cross-functional teams to deliver innovative therapies to patients.

Role Overview Centria Autism seeks an Associate Director of Clinical Services in Tempe, Arizona. This leadership role focuses on strengthening care for children with autism by guiding clinical operations and supporting a skilled team. The position centers on maintaining high standards and upholding best practices throughout the organization. Key Responsibilities Oversee daily clinical operations to ensure consistent, high-quality care Promote and monitor adherence to established clinical best practices Support and mentor clinical staff, fostering professional growth and collaboration Champion improvements that enhance outcomes for children with autism Location Based in Tempe, Arizona, United States.

Definium Therapeutics, previously known as Mind Medicine, is a pioneering biopharmaceutical company in the clinical stage, focused on developing innovative product candidates aimed at addressing brain health disorders. Our vision is to lead globally in creating and delivering treatments that enhance patient outcomes. We are actively building a pipeline of groundbreaking product candidates that target neurotransmitter pathways crucial for brain health, encompassing both acute perceptual effects and non-perceptual modalities.Founded in 2019, we are on a trajectory of rapid expansion, continuously enhancing our global presence. We are in search of dynamic, high-impact individuals across various clinical, technical, and business operational domains to bolster our team of intelligent, patient-centered professionals.The Associate Director of Clinical Operations is responsible for overseeing trial-level operations within the organization. This role requires operational expertise to ensure the successful cross-functional delivery of assigned global clinical trials, adhering to agreed timelines and budgets while complying with all relevant SOPs and regulatory standards. The ADCO will oversee external service providers, manage the planning and execution of both internally and externally managed trials, from the initial protocol synopsis to the availability of the Clinical Study Report (CSR) and appropriate trial result disclosures.The ADCO leads the cross-functional Trial Team (CTT), engaging with all team members to construct the trial operational plan, and is jointly responsible with the Study Clinician and Clinical Scientist for managing external service provider contracts and budgets, ensuring alignment with organizational goals. This role provides operational leadership for trial execution, defines risk mitigation strategies, and ensures their implementation.Key Responsibilities:Lead the cross-functional Trial Team (CTT), monitoring project deliverables and timelines. Proactively manage to ensure milestones are achieved, identifying risks and implementing mitigation strategies.Ensure the trial is delivered within the agreed/projected budget. Manage trial budget accurately, including updates for scope changes and reconciliation of trial costs. Oversee trial-level contract management, including review and approval of contracts and change orders to ensure compliance with service delivery.Provide leadership for trial implementation, driving feasibility assessments and ensuring all operational aspects align with strategic objectives.

Role overview The Associate Director of Clinical Data Management leads daily operations for clinical data management activities at Capstan Medical. Based in Santa Cruz, California, this position ensures that clinical trial data is managed professionally and delivered on schedule throughout all phases of research. The role involves participating in Clinical Team meetings and working closely with functional leaders to support clinical trial success. Main responsibilities Define strategies and set requirements for capturing and processing clinical data at the project level. Oversee the accuracy, consistency, and completeness of clinical data during the entire trial lifecycle. Represent data management in cross-functional meetings and coordinate with other leaders. Manage external vendors providing clinical data services and ensure they meet quality standards. Supervise data management tasks, including: Serious Adverse Event (SAE) reconciliation Third-party vendor data reconciliation Medical coding processing Protocol deviation collection Query management to identify and resolve data errors or inconsistencies Oversee outsourced and partner-supported clinical trials, including scoping, project management, relationship management, deliverable approval, and coordination with internal reviewers. Identify and develop data management resources as the team expands. Location This role is based in Santa Cruz, California.