Director Clinical Operations
1 week ago
A clinical-stage biotechnology company based in Waltham, with a primary focus on severe respiratory disorders, is seeking a dynamic and strategic leader to oversee late stage clinical trial operations . The Clinical Operations Director will be instrumental in planning, managing, and ensuring the successful execution of clinical studies within an outsourced framework. This role demands a proactive approach to guiding clinical operations, ensuring that project milestones and timelines are achieved. The position reports directly to the Head of Clinical Operations.
Key Responsibilities:
- Lead the comprehensive management of large-scale, multi-center global clinical trials, ensuring adherence to Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), and alignment with budgetary and timeline constraints.
- Develop and implement robust clinical operational strategies to facilitate the effective delivery of clinical studies, collaborating closely with Clinical Research Organizations (CROs) and internal stakeholders.
- Identify potential risks and devise proactive mitigation strategies in partnership with CRO counterparts, ensuring seamless study progression.
- Manage relationships with CROs and vendors, overseeing contract negotiations, budget management, and the development of contingency plans for clinical trials.
- Ensure all clinical activities comply with internal policies, GCP standards, and relevant regulatory requirements, maintaining a state of inspection readiness.
- Participate in the selection and qualification processes for CROs and vendors as needed.
Qualifications:
- Bachelor’s Degree in Life Sciences or a related field; an advanced degree is highly desirable.
- A minimum of 8 years of experience in clinical development/operations, with a proven track record in leadership roles overseeing global clinical studies and programs
- Experience in managing Ph2 or Ph3 clinical trials within the respiratory therapeutic area is preferred.
Skills and Abilities:
- Demonstrated leadership capabilities in managing large, cross-functional teams.
- In-depth understanding of global regulatory and compliance requirements for clinical research, including local regulations and ICH GCP guidelines, with experience in global regulatory inspections.
- Strong strategic and analytical thinking skills, with the ability to integrate detailed scientific, clinical, and business information into cohesive operational strategies.
- Proven experience in global clinical operations and development across various therapeutic areas, with the capacity to quickly adapt to new indications.
-
Associate Director, Clinical Data
3 weeks ago
Waltham, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple,...
-
Associate Director, Clinical Data
2 weeks ago
Waltham, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex...
-
Director Clinical Operations
4 days ago
Waltham, United States Trebla Talent Full time🚨Director/Senior Director of Clinical Operations 🚨🌟 Location: 3-days in Greater Boston office About the Company:This pre-IPO, clinical-stage biotech is pioneering NK cell therapies and turning heads with its innovative approach. With nearly 8 active clinical programs and nearly $1 billion in private funding, this dynamic company is setting the stage...
-
Clinical Trials Operations Director
3 days ago
Waltham, Massachusetts, United States ClinLab Staffing Full timeClinical Trials Operations Director OpportunityAt ClinLab Staffing, we are seeking an experienced Clinical Trials Operations Director to lead our clinical trials operations team. This is a dynamic and challenging role that requires strong leadership and management skills.About the Role:The Clinical Trials Operations Director will be responsible for...
-
waltham, United States Trebla Talent Full time🚨Director/Senior Director of Clinical Operations 🚨🌟 Location: 3-days in Greater Boston office About the Company:This pre-IPO, clinical-stage biotech is pioneering NK cell therapies and turning heads with its innovative approach. With nearly 8 active clinical programs and nearly $1 billion in private funding, this dynamic company is setting the stage...
-
Waltham, Massachusetts, United States Lifelancer Full timeJob SummaryWe are seeking an experienced Clinical Operations Director to lead the execution of clinical development activities within our company. As a pivotal role, you will be responsible for executing the clinical operational strategy to ensure timely completion of trials and compliance with local and global regulations.This is a unique opportunity to...
-
Director, Clinical Operations
2 months ago
Waltham, United States Upstream Bio Full timePosition Summary: Upstream Bio seeks a resourceful, purpose-driven, integrative thinker for an important role overseeing our clinical trials and contributing to clinical development plan strategy across our indications. This key role will plan, oversee and drive delivery of clinical studies in a fully outsourced model. Additionally, this individual will...
-
Director, Clinical Operations
2 months ago
Waltham, United States Upstream Bio Full timePosition Summary: Upstream Bio seeks a resourceful, purpose-driven, integrative thinker for an important role overseeing our clinical trials and contributing to clinical development plan strategy across our indications. This key role will plan, oversee and drive delivery of clinical studies in a fully outsourced model. Additionally, this individual will...
-
Director, Clinical Operations
4 weeks ago
waltham, United States Upstream Bio Full timePosition Summary: Upstream Bio seeks a resourceful, purpose-driven, integrative thinker for an important role overseeing our clinical trials and contributing to clinical development plan strategy across our indications. This key role will plan, oversee and drive delivery of clinical studies in a fully outsourced model. Additionally, this individual will...
-
Director, Clinical Operations
4 weeks ago
waltham, United States Upstream Bio Full timePosition Summary: Upstream Bio seeks a resourceful, purpose-driven, integrative thinker for an important role overseeing our clinical trials and contributing to clinical development plan strategy across our indications. This key role will plan, oversee and drive delivery of clinical studies in a fully outsourced model. Additionally, this individual will...
-
Director, Clinical Operations
2 weeks ago
Waltham, United States Upstream Bio Full timePosition Summary:Upstream Bio seeks a resourceful, purpose-driven, integrative thinker for an important role overseeing our clinical trials and contributing to clinical development plan strategy across our indications. This key role will plan, oversee and drive delivery of clinical studies in a fully outsourced model. Additionally, this individual will...
-
Director, Clinical Operations
2 weeks ago
Waltham, United States Upstream Bio Full timePosition Summary:Upstream Bio seeks a resourceful, purpose-driven, integrative thinker for an important role overseeing our clinical trials and contributing to clinical development plan strategy across our indications. This key role will plan, oversee and drive delivery of clinical studies in a fully outsourced model. Additionally, this individual will...
-
waltham, United States Conjugate Group Full timeA clinical-stage biotechnology company based in Waltham, with a primary focus on severe respiratory disorders, is seeking a dynamic and strategic leader to oversee late stage clinical trial operations . The Clinical Operations Director will be instrumental in planning, managing, and ensuring the successful execution of clinical studies within an outsourced...
-
waltham, United States Conjugate Group Full timeA clinical-stage biotechnology company based in Waltham, with a primary focus on severe respiratory disorders, is seeking a dynamic and strategic leader to oversee late stage clinical trial operations . The Clinical Operations Director will be instrumental in planning, managing, and ensuring the successful execution of clinical studies within an outsourced...
-
Waltham, United States Upstream Bio Full timePosition Summary: We seek a highly motivated and experienced Medical Director/Senior Medical Director of Clinical Development to lead clinical program(s) for verekitug in COPD. This role will report to the Vice President, Clinical Development. The successful candidate will be a leader in the organization, yill successfully maintain alignment and excellent...
-
waltham, United States Upstream Bio Full timePosition Summary: We seek a highly motivated and experienced Medical Director/Senior Medical Director of Clinical Development to lead clinical program(s) for verekitug in COPD. This role will report to the Vice President, Clinical Development. The successful candidate will be a leader in the organization, yill successfully maintain alignment and excellent...
-
waltham, United States Upstream Bio Full timePosition Summary: We seek a highly motivated and experienced Medical Director/Senior Medical Director of Clinical Development to lead clinical program(s) for verekitug in COPD. This role will report to the Vice President, Clinical Development. The successful candidate will be a leader in the organization, yill successfully maintain alignment and excellent...
-
Waltham, United States Upstream Bio Full timePosition Summary: We seek a highly motivated and experienced Medical Director/Senior Medical Director of Clinical Development to lead clinical program(s) for verekitug in COPD. This role will report to the Vice President, Clinical Development. The successful candidate will be a leader in the organization, yill successfully maintain alignment and excellent...
-
Director, Clinical Operational Excellence
8 hours ago
Waltham, MA, United States Deciphera Pharmaceuticals, Inc Full timeDirector, Clinical Operational Excellence Full-time Work Type: Full time Job Location: On-Site Waltham Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep...
-
Lead Clinical Operations Strategist
3 days ago
Waltham, Massachusetts, United States Conjugate Group Full timeConjugate Group is seeking a highly skilled and strategic leader to oversee late-stage clinical trial operations as the Clinical Operations Director. This role demands a proactive approach to guiding clinical operations, ensuring that project milestones and timelines are achieved.About the Role:We are looking for an experienced professional with a minimum of...
