Draig Therapeutics
Senior Clinical Trial Manager (or Associate Director)
Title:
Senior Manager (Associate Director) Clinical Trial
About Draig Therapeutics Draig Therapeutics is an exciting, rapidly growing clinical-stage biotech backed by a transformative $140 million Series A financing - one of the largest ever in neuropsychiatric drug development. We are pioneering innovative small-molecule therapies aimed at fundamentally transforming the treatment landscape for depression and neurological disorders.
Why Join Draig? At Draig Therapeutics, you’ll join a science-first, mission-driven biotech that is redefining what a small, agile, and deeply collaborative organization can achieve. Backed by strong investors and propelled by a bold CNS discovery pipeline, Draig brings together world-class scientists, a caring culture, and the energy of a company on an incredible growth trajectory. Here, innovation and speed aren’t just encouraged - they’re expected. You’ll partner closely across Discovery, Nonclinical, and Clinical Development, helping to shape programmes that have the potential to transform patient lives. This is an environment where your voice matters, your expertise has real impact, and your work directly influences how promising molecules move from concept into the clinic. At Draig, you won’t just contribute to groundbreaking science - you’ll help build a biotech with purpose, speed, and heart. For more info, please visit our website.
Responsibilities This role provides strategic clinical leadership across the asset’s development program, shaping and executing clinical development plans and individual study designs in line with the overall lifecycle strategy. The position serves as the clinical lead for fully outsourced trials, overseeing sponsor responsibilities for protocol design, medical monitoring, data interpretation, and vendor/CRO performance to ensure studies are conducted in accordance with ICH GCP, regulatory, and internal quality standards. As a core member of cross-functional asset and project teams, the role partners with clinical operations, regulatory, safety, and biostatistics colleagues to integrate clinical insights into program decisions, drive delivery of key milestones, and maximize the therapeutic potential of the asset.
Provide clinical and scientific leadership to asset and clinical project teams, ensuring that study objectives align with the overall clinical development plan.
Collaborate with cross-functional partners (clinical operations, regulatory, safety, biostats, CMC, commercial) to design and implement early- and late-phase clinical trials.
Develop and optimise key clinical documents, including clinical trial protocols, investigator brochures, informed consent forms, and other core regulatory documents.
Review clinical data from ongoing clinical trials to ensure data quality and trial integrity.
Interpret clinical, safety, and biomarker data to inform go/no‑go decisions, publications, and regulatory submissions.
Lead the setup and day‑to‑day oversight of fully outsourced, full-service clinical trials, ensuring adherence to corporate SOPs, ICH‑GCP, and applicable regulatory requirements.
Provide oversight of key outsourced activities, including clinical conduct at sites, data management, statistical analyses, drug supply management, and regulatory submissions.
Own clinical budgets and timelines for assigned studies, including forecasting, tracking, and proactively managing risks to ensure delivery against agreed milestones.
Prepare and present clear, accurate, and timely reports on clinical trial status, risks, and data quality to senior leadership and governance bodies (e.g., monthly and quarterly updates).
Serve as clinical lead for one or more trials/ programs, guiding the work of the clinical team and ensuring alignment with asset and portfolio strategy.
Represent the clinical function at asset project teams and, as needed, at Draig leadership or governance meetings, providing a clinical perspective and recommendations.
Education and Experience
Bachelor’s degree in a relevant scientific discipline (e.g., Biological Sciences, Psychology, Life Sciences) or equivalent experience in clinical research or drug development.
Extensive experience in Clinical Operations, including hands‑on oversight of fully outsourced, global clinical trials across early and late development phases.
Proven track record
managing multiple concurrent clinical programs and priorities
in a fast‑paced biotech or pharmaceutical environment.
Strong working knowledge of ICH GCP and applicable regulatory requirements, with direct experience conducting studies under an IND or equivalent regulatory framework.
Demonstrated experience leading and managing internal cross‑functional teams and external partners (CROs, vendors, consultants, and investigative sites).
Broad understanding of adjacent drug development functions (e.g., clinical development, regulatory affairs, data management, biostatistics, safety/pharmacovigilance) and how they integrate with clinical operations.
Strong clinical and scientific acumen, enabling effective interpretation of trial data and informed input into study design and development strategy.
Advanced project management skills, including budget development, financial tracking, risk management, and delivery to timelines for complex, global studies.
Excellent knowledge of clinical trial processes, systems, and tools (e.g., CTMS, EDC, eTMF), with the ability to oversee quality, data integrity, and inspection readiness.
Proven leadership and stakeholder‑management capabilities, with the ability to influence without authority and build strong relationships across functions and with external partners.
Exceptional communication skills (written and verbal), with experience preparing and presenting clear status updates, metrics, and risk/mitigation plans to senior leadership.
High level of organisational ability, attention to detail, and agility in a dynamic environment, with a proactive, solution‑oriented mindset.
Planning Creates comprehensive and realistic business plans by defining deliverables, milestones, accountabilities, and measures of success to achieve objectives, while ensuring the optimal use of resources to meet efficiency, requests, and due dates. Allocates appropriate amounts of time for completing own work. Prioritise critical and less critical activities. Proactively plans to avoid problems.
Collaboration Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross‑company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.
Execution Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high‑quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.
Relationship Building Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity, and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.
TO ALL AGENCIES: Please, no phone calls or emails to any employee of Draig about our openings. All resumes submitted by search firms/employment agencies to any employee at Draig Therapeutics via email, the internet, or in any form and/or method will be deemed the sole property of Draig Therapeutics unless Draig engaged such search firms/employment agencies for this position and a valid agreement with Draig is in place. In the event a candidate who was submitted outside of the Draig Tx agency engagement process is hired, no fee or payment of any kind will be paid.
Draig Therapeutics, Inc. is an equal employment opportunity employer. It does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
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Senior Manager (Associate Director) Clinical Trial
About Draig Therapeutics Draig Therapeutics is an exciting, rapidly growing clinical-stage biotech backed by a transformative $140 million Series A financing - one of the largest ever in neuropsychiatric drug development. We are pioneering innovative small-molecule therapies aimed at fundamentally transforming the treatment landscape for depression and neurological disorders.
Why Join Draig? At Draig Therapeutics, you’ll join a science-first, mission-driven biotech that is redefining what a small, agile, and deeply collaborative organization can achieve. Backed by strong investors and propelled by a bold CNS discovery pipeline, Draig brings together world-class scientists, a caring culture, and the energy of a company on an incredible growth trajectory. Here, innovation and speed aren’t just encouraged - they’re expected. You’ll partner closely across Discovery, Nonclinical, and Clinical Development, helping to shape programmes that have the potential to transform patient lives. This is an environment where your voice matters, your expertise has real impact, and your work directly influences how promising molecules move from concept into the clinic. At Draig, you won’t just contribute to groundbreaking science - you’ll help build a biotech with purpose, speed, and heart. For more info, please visit our website.
Responsibilities This role provides strategic clinical leadership across the asset’s development program, shaping and executing clinical development plans and individual study designs in line with the overall lifecycle strategy. The position serves as the clinical lead for fully outsourced trials, overseeing sponsor responsibilities for protocol design, medical monitoring, data interpretation, and vendor/CRO performance to ensure studies are conducted in accordance with ICH GCP, regulatory, and internal quality standards. As a core member of cross-functional asset and project teams, the role partners with clinical operations, regulatory, safety, and biostatistics colleagues to integrate clinical insights into program decisions, drive delivery of key milestones, and maximize the therapeutic potential of the asset.
Provide clinical and scientific leadership to asset and clinical project teams, ensuring that study objectives align with the overall clinical development plan.
Collaborate with cross-functional partners (clinical operations, regulatory, safety, biostats, CMC, commercial) to design and implement early- and late-phase clinical trials.
Develop and optimise key clinical documents, including clinical trial protocols, investigator brochures, informed consent forms, and other core regulatory documents.
Review clinical data from ongoing clinical trials to ensure data quality and trial integrity.
Interpret clinical, safety, and biomarker data to inform go/no‑go decisions, publications, and regulatory submissions.
Lead the setup and day‑to‑day oversight of fully outsourced, full-service clinical trials, ensuring adherence to corporate SOPs, ICH‑GCP, and applicable regulatory requirements.
Provide oversight of key outsourced activities, including clinical conduct at sites, data management, statistical analyses, drug supply management, and regulatory submissions.
Own clinical budgets and timelines for assigned studies, including forecasting, tracking, and proactively managing risks to ensure delivery against agreed milestones.
Prepare and present clear, accurate, and timely reports on clinical trial status, risks, and data quality to senior leadership and governance bodies (e.g., monthly and quarterly updates).
Serve as clinical lead for one or more trials/ programs, guiding the work of the clinical team and ensuring alignment with asset and portfolio strategy.
Represent the clinical function at asset project teams and, as needed, at Draig leadership or governance meetings, providing a clinical perspective and recommendations.
Education and Experience
Bachelor’s degree in a relevant scientific discipline (e.g., Biological Sciences, Psychology, Life Sciences) or equivalent experience in clinical research or drug development.
Extensive experience in Clinical Operations, including hands‑on oversight of fully outsourced, global clinical trials across early and late development phases.
Proven track record
managing multiple concurrent clinical programs and priorities
in a fast‑paced biotech or pharmaceutical environment.
Strong working knowledge of ICH GCP and applicable regulatory requirements, with direct experience conducting studies under an IND or equivalent regulatory framework.
Demonstrated experience leading and managing internal cross‑functional teams and external partners (CROs, vendors, consultants, and investigative sites).
Broad understanding of adjacent drug development functions (e.g., clinical development, regulatory affairs, data management, biostatistics, safety/pharmacovigilance) and how they integrate with clinical operations.
Strong clinical and scientific acumen, enabling effective interpretation of trial data and informed input into study design and development strategy.
Advanced project management skills, including budget development, financial tracking, risk management, and delivery to timelines for complex, global studies.
Excellent knowledge of clinical trial processes, systems, and tools (e.g., CTMS, EDC, eTMF), with the ability to oversee quality, data integrity, and inspection readiness.
Proven leadership and stakeholder‑management capabilities, with the ability to influence without authority and build strong relationships across functions and with external partners.
Exceptional communication skills (written and verbal), with experience preparing and presenting clear status updates, metrics, and risk/mitigation plans to senior leadership.
High level of organisational ability, attention to detail, and agility in a dynamic environment, with a proactive, solution‑oriented mindset.
Planning Creates comprehensive and realistic business plans by defining deliverables, milestones, accountabilities, and measures of success to achieve objectives, while ensuring the optimal use of resources to meet efficiency, requests, and due dates. Allocates appropriate amounts of time for completing own work. Prioritise critical and less critical activities. Proactively plans to avoid problems.
Collaboration Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross‑company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.
Execution Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high‑quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.
Relationship Building Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity, and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.
TO ALL AGENCIES: Please, no phone calls or emails to any employee of Draig about our openings. All resumes submitted by search firms/employment agencies to any employee at Draig Therapeutics via email, the internet, or in any form and/or method will be deemed the sole property of Draig Therapeutics unless Draig engaged such search firms/employment agencies for this position and a valid agreement with Draig is in place. In the event a candidate who was submitted outside of the Draig Tx agency engagement process is hired, no fee or payment of any kind will be paid.
Draig Therapeutics, Inc. is an equal employment opportunity employer. It does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
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