Current jobs related to (Associate) Director Clinical Operations and Vendor Management - Boston - Bicara Therapeutics
-
Associate Director, Clinical Data Management
1 week ago
boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Associate Director, Clinical Data Management
1 week ago
boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Associate Director, Clinical Data Management
3 months ago
Boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Associate Director, Clinical Data Management
3 months ago
Boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Associate Director, Vendor Quality Management
4 weeks ago
Boston, United States Vertex Full timeJob DescriptionGeneral Summary:The Associate Director, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This position is responsible for developing, maintaining, and disseminating vendor data and...
-
Associate Director, Sterile Drug Products
1 month ago
Boston, United States Inozyme Pharma Full timeTitle: Associate Director, Sterile Drug Products & Vendor ManagementPosition Overview: We are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization...
-
Associate Director, Sterile Drug Products
1 month ago
Boston, United States Inozyme Pharma Full timeTitle: Associate Director, Sterile Drug Products & Vendor ManagementPosition Overview: We are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization...
-
Associate Director, Sterile Drug Products
1 month ago
Boston, United States Inozyme Pharma Full timePosition Overview: We are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. You will play a key role in vendor management and...
-
Associate Director, Clinical Trial Management
3 weeks ago
Boston, United States Bicara Therapeutics Full timeRole OverviewThe AD, Clinical Trial Management works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Director, Clinical Operations. This role may work collaboratively on one trial...
-
Associate Director, Clinical Trial Management
3 weeks ago
Boston, United States Bicara Therapeutics Full timeRole OverviewThe AD, Clinical Trial Management works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Director, Clinical Operations. This role may work collaboratively on one trial...
-
Clinical Trial Manager, Start Up
1 week ago
boston, United States Clinical Dynamix Full timeClinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...
-
Clinical Trial Manager, Start Up
1 week ago
Boston, United States Clinical Dynamix Full timeClinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...
-
Clinical Trial Manager, Start Up
1 week ago
Boston, United States Clinical Dynamix Full timeClinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...
-
Clinical Operations Manager
5 days ago
Boston, United States Proclinical Staffing Full timeClinical Operations Manager - Contract- Boston, RemoteProclinical is seeking a dedicated and collaborative individual to fill the role of Clinical Operations Manager at a biotech company. Primary Responsibilities:The successful candidate will play a crucial role in identifying potential vendors and Contract Research Organizations (CROs) for clinical trial...
-
Clinical Operations Manager
5 days ago
Boston, United States Proclinical Staffing Full timeClinical Operations Manager - Contract- Boston, RemoteProclinical is seeking a dedicated and collaborative individual to fill the role of Clinical Operations Manager at a biotech company. Primary Responsibilities:The successful candidate will play a crucial role in identifying potential vendors and Contract Research Organizations (CROs) for clinical trial...
-
Vendor Operations Analyst
3 weeks ago
boston, United States Russell Tobin Full timeRussell Tobin & Associates is currently seeking a Vendor Operations Analyst to work for our client in the sports industry. Apply now for consideration!Contract: 9 monthsLocation: Boston, MA, Remote: must have availability to work in office as needed, currently 2x a month and for special projectsPay Range: 39-44/hr depending on...
-
Vendor Operations Analyst
3 weeks ago
boston, United States Russell Tobin Full timeRussell Tobin & Associates is currently seeking a Vendor Operations Analyst to work for our client in the sports industry. Apply now for consideration!Contract: 9 monthsLocation: Boston, MA, Remote: must have availability to work in office as needed, currently 2x a month and for special projectsPay Range: 39-44/hr depending on...
-
Vendor Operations Analyst
3 weeks ago
Boston, United States Russell Tobin Full timeRussell Tobin & Associates is currently seeking a Vendor Operations Analyst to work for our client in the sports industry. Apply now for consideration!Contract: 9 monthsLocation: Boston, MA, Remote: must have availability to work in office as needed, currently 2x a month and for special projectsPay Range: 39-44/hr depending on...
-
Vendor Operations Analyst
3 weeks ago
Boston, United States Russell Tobin Full timeRussell Tobin & Associates is currently seeking a Vendor Operations Analyst to work for our client in the sports industry. Apply now for consideration!Contract: 9 monthsLocation: Boston, MA, Remote: must have availability to work in office as needed, currently 2x a month and for special projectsPay Range: 39-44/hr depending on...
-
Associate Director, Global Discovery Operations Lead
2 months ago
Boston, United States Jarvis Walker Full timeAssociate Director,Global Discovery Operations LeadThe Associate Director, Operations Lead is a central and critical role in Global R&D Discovery IT that is responsible for providing excellent user experience which relies on stable, consistent, and compliant operations and support.In this role, the Operations Lead will oversee delivery of a global services...
(Associate) Director Clinical Operations and Vendor Management
4 months ago
The Assistant Director, Clinical Operations will be accountable for strategic and operational management and successful execution of late phase clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and regulatory requirements. They are well versed in knowledge of operational methodologies, clinical research, ICH/GCP Guidelines, program management, communication to upper management and delegation to/oversight of Clinical Trial Managers. They are responsible for the development of the clinical timelines and are the co-author of the individual study timelines/deliverables/milestones.
Key Responsibilities
- Lead certain aspects of clinical operations to support the scope of our clinical development programs.
- Support the clinical operations strategy and business model to support high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs with early generation of data to support registration.
- Work closely with external collaboration partners with a focus on relationship management and efficiency
- Contributes to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with project teams and stakeholders.
- Partner closely with leadership to design, plan and execute innovative clinical trial designs leveraging the needs and opportunities of biologics development.
- Cultivates relationships with external partners such as clinical investigators, clinicians, and scientists in support of innovation and business development.
- Develop, propose and implement clinical trial strategy for responsible pipeline programs and indication.
- Lead the proactive identification, assessment, and management of clinical study-related issues and risks.
- Provide clinical operations support and management for all study activities including site identification and selection, enrollment models, clinical supply planning, CRO selection and negotiations, budget planning and trial execution.
- Monitor study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable.
- Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met.
- Collaborate with internal medical director in development and authorship of study protocol.
- Collaborate with scientific teams in project planning for future programs.
- Participate in Case Report Form design and user acceptance testing in partnership with Data Management.
- Oversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics.
- Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc.
- Contribute to and/or author clinical sections of regulatory documents including Investigators’ Brochures, safety updates, and responses to Health Authority / Ethics Committee questions.
- Contribute to and/or author publications with cross functional team members.
- Support the development and implementation of SOPs, Quality Management Systems and GxP processes.
Qualifications
- years of experience in clinical operations and a BS/BA or higher degree in a relevant scientific discipline.
- 3 oncology experience required.
- clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.
- of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
- and ability to manage global or regional teams in a virtual environment.
- knowledge of human subject's research ethics and clinical trial practices and policies to include ICH, GCP, FDA regulations, IRB policies, complex visit structures, budgets and contracts.
- in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
- decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
- be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
- leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables.
- to travel up to 10-20% of the time.
Company Overview
Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is available at www.bicara.com.
Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.
Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
