- Develop and implement strategic plans for clinical operations in alignment with organizational objectives. Identify opportunities for process improvement and optimization to enhance efficiency and quality.
- Provide leadership, guidance, and mentorship to the clinical operations team. Foster a culture of collaboration, innovation, and continuous learning to support professional development and growth. Continue to buildout the clinical operations team
- Oversee the planning, execution, and monitoring of clinical trials. Ensure compliance with regulatory requirements, study protocols, and quality standards.
- Work closely with cross-functional teams, including clinical development, regulatory affairs, medical affairs, and data management, to drive integrated strategies and deliver comprehensive solutions.
- Identify potential risks and challenges in clinical operations and develop mitigation strategies to minimize impact on study timelines and objectives.
- Implement and maintain quality management systems to uphold compliance with regulatory requirements and industry standards. Conduct regular audits and assessments to ensure adherence to best practices.
- Build and maintain relationships with key internal and external stakeholders, including investigators, opinion leaders, regulatory authorities, and advocacy groups. Represent the organization at relevant meetings, conferences, and events.
- Establish key performance indicators (KPIs) and metrics to monitor the performance of clinical operations activities. Analyze data and metrics to drive informed decision-making and continuous improvement initiatives.
- Advanced degree in life sciences, pharmacy, or related field. (e.g., MD, PhD, PharmD)
- Minimum of 11 years of experience in clinical operations management within the pharmaceutical or biotechnology industry.
- Demonstrated leadership experience with a track record of successfully leading and managing clinical operations teams.
- Experience in therapeutic area such as oncology, immunotherapy, or gene therapy is highly desirable.
- Strong communication, interpersonal, and problem-solving skills.
- Proven ability to build and maintain effective relationships with internal and external stakeholders.
- Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment.
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Director Clinical Operations
1 week ago
Green Key Resources Boston, United StatesJoin our team as a Director Clinical Operations where you'll play a pivotal role in orchestrating the planning, execution, and oversight of clinical studies. Your responsibilities include managing day-to-day operations, collaborating with Clinical Research Organizations (CROs), c ...
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Director, Clinical Operations
2 weeks ago
Entrada Therapeutics Boston, United States Full timeThe Organization · What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. · O ...
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Director, Clinical Operations
1 week ago
BioSpace Boston, MA, United StatesThe Organization · What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. · ...
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Director, Clinical Operations
1 week ago
Entrada Therapeutics Inc. Boston, MA, United StatesThe Organization · What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. · ...
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Director Clinical Operations
2 weeks ago
EPM Scientific - Phaidon International Boston, MA, United StatesDirector, Clinical Operations · $215,000-$240,000 · Boston, MA (Hybrid) · The biotechnology company is at the forefront of groundbreaking research in the field of Immuno-Oncology. They harness the power of the immune system to fight cancer, firmly establishing themselves as pion ...
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Director of Clinical Operations
2 days ago
Global Life Science Hub Boston, United StatesJob Description · Job DescriptionGlobal Life Science Hub is partnered with an incredibly unique and revolutionary biotech company, developing an insane alternative to chemotherapy treatment by creating a unique receptor-binding protein that can fuse multiple immunotherapeutic vac ...
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Clinical Operations Intern
4 days ago
Withings Boston, United StatesJob Description · Job DescriptionWithings revolutionized connected health by launching the world's first Wi-Fi scale in 2009. Since then, we've become known for innovative devices which pair timeless design and advanced sensing capabilities. Our award-winning ecosystem includes t ...
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Clinical Operations Intern
1 week ago
Withings Boston, United StatesWithings revolutionized connected health by launching the world's first Wi-Fi scale in 2009. Since then, we've become known for innovative devices which pair timeless design and advanced sensing capabilities. Our award-winning ecosystem includes the world's first activity trackin ...
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Director, Clinical Operations
1 week ago
Vor Biopharma Inc. Cambridge, United StatesWho we are looking for: · Vor Bio is seeking a highly motivated Director, Clinical Operations to join our fast-paced, dynamic team at this exciting phase of our Clinical Development Program. · Key areas of responsibility: · * Executes the day-to-day operations of clinical trials ...
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Director, Clinical Operations
1 week ago
Foghorn Therapeutics Inc. Cambridge, United StatesOur Culture: Why work with us? · At Foghorn Therapeutics, we believe in "People First, Mission Always." · We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that ...
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Director, Clinical Operations
1 week ago
Boston Pharmaceuticals Cambridge, United StatesCompany Overview · Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being ...
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Randstad Life Sciences US Cambridge, United StatesA major Pharmaceutical company, From accelerating drug discovery and early development to a rapidly expanding pipeline and a world-class team, delivering on the promise of treating infectious and other diseases. · SKILLS: · UNBLINDED study experience · Experience w/ IP documents ...
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Director, Clinical Operations
1 week ago
Boston Pharmaceuticals Cambridge, United StatesCompany Overview · Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being ...
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Clinical Operations Leader
2 weeks ago
Bill and Melinda Gates Foundation Cambridge, United States"We are focused on results. Those that can be measured. And those measured in ways beyond numbers. We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcome ...
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Director, Clinical Operations
4 days ago
Foghorn Therapeutics Cambridge, United StatesJob Description · Job DescriptionOur Culture: Why work with us? · At Foghorn Therapeutics, we believe in "People First, Mission Always." · We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, ...
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Associate Director Clinical Operations
2 weeks ago
Clinical Dynamix Boston, United StatesAssociate Director, Early Development (Clinical Operations) · The Associate Director, Early Development Clinical Operations is responsible for leading projects to support the execution of clinical studies aligned with the clinical development plan according to the agreed upon tim ...
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The Steely Group Cambridge, United StatesReporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effectiv Clinical, Operations, Clinic, ...
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The Steely Group Cambridge, United StatesJob Description · Job Description · Reporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing · instructions/information · from study managers or global project leaders to support Clinical Operations by ensuring the timely ...
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VP of Global Clinical Operations
4 days ago
Jobot Boston, MA, United StatesOur client is a full service law firm that offers tailored support and an unparalleled depth of legal expertise. Over the past three and a half decades, we have been dedicated to offering education, reliable counsel, and in-depth analysis to community associations, businesses, an ...
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Clinical Operations Excellence Lead
1 week ago
argenx Boston, United States OTHERThe Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical QMS in a consistent, effective and efficient way within the Global Clinical Operations organization (Global Trial Operations, Data Management, Medical Writing and Glob ...
Director Clinical Operations - Boston, United States - EPM Scientific
Description
Director, Clinical Operations (Hybrid in Boston, MA)
Salary: $220,000- $245,000
This company is a pioneering biotechnology company dedicated to advancing the field of gene therapy to address unmet medical needs and transform the lives of patients worldwide. Founded on the principles of innovation, collaboration, and patient-centricity, they are committed to developing and delivering breakthrough treatments that harness the power of genetic medicine.
They specialize in the research, development, and commercialization of novel gene therapy approaches aimed at treating a wide range of genetic disorders, rare diseases, and other debilitating conditions.
Position Overview:
The Director of Clinical Operations is a key leadership role responsible for overseeing and managing the clinical operations for a cutting-edge gene therapy company. This individual will play a crucial role in ensuring the successful execution of clinical trials and programs in the field of gene therapy, as well as fostering strong relationships with internal and external stakeholders. The Director of Clinical Operations will lead a team of clinical operations professionals and collaborate closely with other departments to drive operational excellence and achieve organizational goals in this rapidly advancing field.
Responsibilities:
Qualifications:
Note: This is a confidential search. All inquiries and applications will be handled with discretion