EPM Scientific | Director of Clinical Operations
4 days ago
Director of Clinical Operations
Company Overview
We are representing an innovative, clinical-stage biopharmaceutical company focused on developing transformative therapies for patients with autoimmune diseases. Our mission is to harness the body's natural mechanisms to re-balance immune responses, addressing the root causes of chronic autoimmune conditions. Unlike traditional therapies, our approach aims to provide a safer, more effective solution without the long-term side effects or risks often associated with immunosuppressive treatments.
As an early-stage, rapidly growing company, this role provides a unique opportunity to make a significant impact while earning an equity position. Join a dynamic and collaborative team of industry veterans and forward-thinking scientists to help transform how autoimmune diseases are treated.
Position Overview:
The Director of Clinical Operations will oversee the implementation and management of multiple clinical trials, ensuring they are executed on time, within budget, and in compliance with regulatory requirements. This role involves leading vendor relationships, building operational infrastructure, and collaborating with cross-functional teams to support the company’s clinical development strategy. Reporting to the VP of Clinical Operations, the Director will play a pivotal role in the success of the organization’s programs.
Key Responsibilities:
Clinical Trial Execution and Oversight:
- Develop and execute operational plans for clinical trials, managing timelines, budgets, and resources.
- Ensure trials comply with GCP, regulatory guidelines, and internal SOPs while meeting corporate goals.
- Lead the preparation of study documents, including protocols, Investigator’s Brochures, CRFs, ICFs, and study reports.
- Oversee the selection, contracting, and management of CROs and other vendors to ensure timely and high-quality trial execution.
- Review and approve vendor budgets and invoices, ensuring alignment with operational plans.
- Collaborate with patient advocacy groups and external stakeholders to optimize patient recruitment strategies.
- Build and maintain strong relationships with investigators and site staff to support study enrollment and quality.
Operational Infrastructure Development:
- Partner with the VP of Clinical Operations to structure the department and create a highly effective clinical operations team.
- Recruit, manage, and develop clinical operations staff to ensure the department’s success.
- Establish and maintain SOPs, ensuring compliance with ICH-GCP, FDA regulations, and industry best practices.
- Evaluate and implement innovative tools and processes to enhance trial efficiency and data quality.
- Collaborate with senior leadership to align clinical operations goals with corporate objectives.
Compliance and Training:
- Ensure all monitoring activities, study-related processes, and staff training are compliant with regulatory and company standards.
- Oversee regulatory submissions and approvals, including IRB/IEC and country-specific requirements.
Experience, Skills, and Education:
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- Minimum of 8+ years of clinical operations experience, with strong expertise in managing complex trial designs across multiple phases.
- At least 4 years of leadership experience in clinical operations, including team and vendor management.
- Comprehensive knowledge of GCP, ICH guidelines, and global regulatory requirements.
- Demonstrated ability to manage cross-functional teams and external partnerships effectively.
- Strong problem-solving, analytical, and critical thinking skills.
- Exceptional written and verbal communication abilities.
- Self-starter with excellent interpersonal skills and the ability to build and maintain relationships across all levels.
- Detail-oriented, with a proven track record of success in high-pressure, fast-paced environments.
-
boston, United States EPM Scientific Full timeDirector of Clinical OperationsCompany Overview We are representing an innovative, clinical-stage biopharmaceutical company focused on developing transformative therapies for patients with autoimmune diseases. Our mission is to harness the body's natural mechanisms to re-balance immune responses, addressing the root causes of chronic autoimmune conditions....
-
boston, United States EPM Scientific Full timeExecutive Director/VP of Clinical OperationsAbout the OrganizationWe are representing a cutting-edge, clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of autoimmune diseases. Using innovative approaches in cell therapy and advanced T cell engineering, we aim to suppress and eliminate the underlying causes of autoimmune and...
-
boston, United States EPM Scientific Full timeExecutive Director/VP of Clinical OperationsAbout the OrganizationWe are representing a cutting-edge, clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of autoimmune diseases. Using innovative approaches in cell therapy and advanced T cell engineering, we aim to suppress and eliminate the underlying causes of autoimmune and...
-
boston, United States EPM Scientific Full timeAssociate Director/Director of Upstream Process DevelopmentJob Summary: The Director of Upstream Process Development will lead the design, optimization, and scale-up of upstream processes for biologics production, focusing on cell culture and fermentation technologies. This position is pivotal in developing robust, scalable, and cost-efficient processes for...
-
EPM Scientific | Clinical Trial Manager
4 days ago
boston, United States EPM Scientific Full timeJob Title: Clinical Trial Manager (CTM)Location: Boston, MassachusettsDepartment: Clinical OperationsReports to: Director of Clinical OperationsJob Summary: The Clinical Trial Manager (CTM) is responsible for the planning, implementation, and management of clinical trials focused on inflammation-related therapies. This role ensures that clinical trials are...
-
EPM Scientific | Associate Director Insights
4 weeks ago
boston, United States EPM Scientific Full timeAssociate Director Insights & Analytics - Prescription MedicationEPM are looking for an Associate Director, specializing in Market Insights and Analytics, who is eager to leverage data-driven strategies to drive commercial success. This permanent position based in Dallas offers the chance for a strategic thinker with expertise in analytics and stakeholder...
-
EPM Scientific | Associate Director Insights
4 weeks ago
boston, United States EPM Scientific Full timeAssociate Director Insights & Analytics - Prescription MedicationEPM are looking for an Associate Director, specializing in Market Insights and Analytics, who is eager to leverage data-driven strategies to drive commercial success. This permanent position based in Boston offers the chance for a strategic thinker with expertise in analytics and stakeholder...
-
boston, United States EPM Scientific Full timeTitle: Director, Regulatory OperationsA growing biotechnology company is seeking a Director of Regulatory Operations to lead and manage the regulatory strategy and operations for global submissions and systems projects in a dynamic, rapidly evolving environment. This organization is focused on developing innovative therapies for rare and underserved...
-
boston, United States EPM Scientific Full timeTitle: Director, Regulatory OperationsA growing biotechnology company is seeking a Director of Regulatory Operations to lead and manage the regulatory strategy and operations for global submissions and systems projects in a dynamic, rapidly evolving environment. This organization is focused on developing innovative therapies for rare and underserved...
-
boston, United States EPM Scientific Full timeLocated in Cambridge, MA, our client is on a quest for an Associate Director or Director who will play a pivotal role orchestrating innovative launch strategies and driving growth within their dynamic high-growth environment. This position offers not just another job but rather a career-defining opportunity where your expertise can make profound impacts...
-
boston, United States EPM Scientific Full timeDirector of Downstream Process DevelopmentJob Summary: The Director of Downstream Process Development will lead the development and optimization of downstream processes for the production of novel biologics. This role is responsible for designing, scaling up, and transferring purification processes from laboratory scale to manufacturing, ensuring compliance...
-
boston, United States EPM Scientific Full timeDirector of Downstream Process DevelopmentJob Summary: The Director of Downstream Process Development will lead the development and optimization of downstream processes for the production of novel biologics. This role is responsible for designing, scaling up, and transferring purification processes from laboratory scale to manufacturing, ensuring compliance...
-
Boston, Massachusetts, United States EPM Scientific Full timeJob OverviewEPM Scientific is seeking a highly experienced Director of Downstream Process Development to lead the development and optimization of downstream processes for the production of novel biologics. This role is responsible for designing, scaling up, and transferring purification processes from laboratory scale to manufacturing, ensuring compliance...
-
Director of Clinical Operations
4 days ago
Boston, United States EPM Scientific Full timeJob Title: Director of Clinical OperationsLocation: Boston, Massachussets Department: Clinical OperationsReports to: Vice President of Clinical DevelopmentJob Summary: The Director of Clinical Operations will lead and oversee all clinical trial activities for oncology programs. This role is critical in ensuring the successful execution of clinical trials,...
-
Director of Clinical Operations
4 days ago
Boston, United States EPM Scientific Full timeDirector of Clinical OperationsCompany Overview We are representing an innovative, clinical-stage biopharmaceutical company focused on developing transformative therapies for patients with autoimmune diseases. Our mission is to harness the body's natural mechanisms to re-balance immune responses, addressing the root causes of chronic autoimmune conditions....
-
boston, United States EPM Scientific Full timeTitle: Vice President Regulatory AffairsAn exciting pharmaceutical company is seeking a VP Regulatory Affairs to join the team in making on a meaningful impact on the lives of patients through innovative healthcare solutions. This mid-sized company currently has multiple already approved products with a strong pipeline on the way. This is an opportunity to...
-
boston, United States EPM Scientific Full timeTitle: Vice President Regulatory AffairsAn exciting pharmaceutical company is seeking a VP Regulatory Affairs to join the team in making on a meaningful impact on the lives of patients through innovative healthcare solutions. This mid-sized company currently has multiple already approved products with a strong pipeline on the way. This is an opportunity to...
-
Boston, Massachusetts, United States EPM Scientific Full timeJob OverviewWe are seeking an experienced Biopharmaceutical Upstream Process Development Lead to join our team at EPM Scientific.
-
Lead Upstream Process Development Manager
2 weeks ago
Boston, Massachusetts, United States EPM Scientific Full timeJob SummaryThe Lead Upstream Process Development Manager will oversee the design, optimization, and scale-up of upstream processes for biologics production, focusing on cell culture and fermentation technologies. This position is crucial in developing robust, scalable, and cost-efficient processes for novel biologic therapeutic products.About the RoleThis...
-
Biopharmaceutical Process Development Lead
5 days ago
Boston, Massachusetts, United States EPM Scientific Full timeThe esteemed pharmaceutical company EPM Scientific is seeking a highly skilled Biopharmaceutical Process Development Lead to join their team. This is an exceptional opportunity for a talented professional to lead the design, optimization, and scale-up of upstream processes for biologics production.In this pivotal role, you will oversee the development and...
