About Curium Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around…
About Curium Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around…
Skills: Process Engineering, cGMP Compliance, Root Cause Analysis, Statistical Process Control, Lean Manufacturing
About Curium Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around…
About Curium Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around…
About Curium Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around…
About Curium Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around…
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Curium est le leader mondial de la médecine nucléaire, acteur intégré du diagnostic et de la thérapie, présent dans plus de 70 pays et jouant un rôle stratégique dans l’accès des patients à des solutions génériques et in…
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Curium est le leader mondial de la médecine nucléaire, acteur intégré du diagnostic et de la thérapie, présent dans plus de 70 pays et jouant un rôle stratégique dans l’accès des patients à des solutions génériques et in…
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About Curium Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around…
About Curium Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around…
ABOUT CURIUM The Group Curium is the world’s largest nuclear medicine company. At Curium, we have a singular focus – to develop, manufacture and supply world-class radiopharmaceutical products around the globe. With manu…
Skills: Scientific Communications, Publication Strategy, Medical Affairs, Theranostics, Lifecycle Management
ABOUT CURIUM The Group Curium is the world’s largest nuclear medicine company. At Curium, we have a singular focus – to develop, manufacture and supply world-class radiopharmaceutical products around the globe. With manu…
Skills: Scientific Publications, Medical Communications, Medical Education, Publication Strategy, Strategic Leadership
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Full-time
bachelor degree
Posted 1d ago
Apply by Jul 14
~40 hrs/week
Responsibilities
The Director of Clinical Operations manages CROs, clinical trial teams, and budgets to ensure the efficient execution of clinical trials against project timelines. This role involves defining operating procedures, adjusting clinical strategies based on market conditions, and liaising with regulatory agencies.
Requirements
Requires a technical degree in a science-related field and 10-15 years of clinical product development experience in pharma, biotech, or a CRO. Candidates must have proven experience in CRO selection, budgetary management, and interaction with FDA/EMA regulatory bodies.
Full job description
About Curium
Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.
Summary of Position
The Director Clinical Operations, reporting to the VP Clinical Operations, will be responsible for managing Clinical Research Organizations (CROs), the clinical trial team and trial budgets, directing activities related to supporting clinical trial design and assuring clinical trials are efficiently and effectively executed against project timelines. This will include facilitating external medical experts as the clinical development program of new products is defined. In addition, the position will define operating procedures bridging sponsor requirements to the CRO ensuring requirements are followed for respective responsibilities.
The position will evaluate clinical product development against target product and medical plan and adjust clinical strategy to meet changing market and competitive conditions. This position requires strategic thinking, interaction with KOL’s, FDA regulatory experience and the ability to work cross functionally to formulate and implement action plans to meet the vision, goals and timelines of the company.
Essential Functions
Assist in development and execution of clinical trials supporting strategic product development programs, both short and long range, to meet financial and business development objectives of the organization.
Oversee the execution and management of clinical trials under Curium sponsorship, ensure compliance with protocols, regulations and best practices.
Coordinate and ensure data collection and integrity.
Plan, develop, organize, implement, direct and evaluate execution of Curium’s clinical product development activities.
Partner with members of the management team to ensure communications are coordinated, support corporate objectives and meet organizational expenditure requirements.
Assist in identification of new vendors/CROs and negotiate contract terms and conditions for major services.
Oversee and manage clinical trial budgets
Partner with members of the management team to ensure communications are coordinated, support corporate objectives and meet organizational expenditure requirements.
Partner with Regulatory as needed to liaise with regulatory agencies regarding clinical trials; support submissions and contribute to/attend authority meetings.
Ensure effective control of clinical product development activities and take corrective action to guarantee that achievement of objectives falls within designated budgets.
Establish and maintain relationships with industry influencers and key community and strategic partners.
Coordinate and assist in the ongoing training and development of clinical development team members.
Provide direction to product development teams by establishing clear goals and objectives for performance.
Help represent the organization at scientific meetings as required.
Present progress reports and strategies to management.
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Requirements
Technical degree in a science related field required.
Ten to fifteen years of broad clinical product development experience in the pharmaceutical, biotech industries or working directly for a CRO.
Experience in the review and selection of CROs.
FDA/EMA regulatory experience is encouraged as is interaction with key opinion leaders (KOL’s).
Budgetary management experience required.
Proven analytical and strategic thinking skills, planning and implementation experience, track record of successful negotiations.
Excellent written and verbal communication and presentation skills.
Team player with high integrity and an open, interactive style with strong interpersonal skills.
Working Conditions:
Willingness to work in a team based environment.
Close attention to detail required.
May be required to sit or stand for long periods of time while performing duties.
Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Related keywords
Nuclear MedicineRadiopharmaceuticalsSPECTPETClinical Research OrganizationsCROFDAEMAHCTGAPIC/SISOUSPNRCcGMPClinical Trials
Driving innovation in nuclear medicine to improve patients’ lives
Industry
Pharmaceutical Manufacturing
Company size
1,001-5,000 employees
Founded
2017
Headquarters
Boston, Massachusetts
LinkedIn followers
79,298
Curium is the global leader in nuclear medicine, providing life-changing diagnostics and treatment to patients all over the world.
We develop, manufacture and distribute world-class radiopharmaceutical products with a renewed focus on cancer, exploring untapped potential for new innovation.
We build on remarkable foundations and a legacy of providing reliable and consistent nuclear solutions to tens of thousands of patients every day. Our proven heritage combined with a pioneering approach are the hallmarks from which we provide life-changing diagnostics and therapeutics. Our people are the root of the incredible impact they have.
As part of our 2030 vision to become an oncology-focused nuclear medicine leader – both in diagnostics and therapy – we will expand our reach further into Japan and China, continuing to roll out our superior products to a global market. The impact of these investments on patients will be life changing.
Our cancer focus is currently in Neuroendocrine Tumors (NETs) and prostate cancer PSMA. We are also working on leveraging the power of AI to improve image quality and accuracy; to identify patterns to help diagnose pathologies and of course to better support physicians.
Our Promise
We strive to make the impossible possible and to be an organization that will change the face of medicine. Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply revolutionary diagnostic and therapeutic radiopharmaceuticals to our customers around the globe with unrivaled reliability and superior service.
Offices: 2 Seaport Ln, 2nd floor, Boston, Massachusetts 02210, US · 20, rue Quentin Bauchart, Paris, France 75008, FR · 111 Westport Plaza, Suite 800, St. Louis, MO 63043, US · Biopôle Clermont-Limagne 3 rue Marie Curie 63360, Saint-Beauzire, FR · Westerduinweg 3, Petten, North Holland 1755, NL
Nuclear MedicinePET ImagingMolecular ImagingcGMP ManufacturingContract Manufacturingand SPECT ImagingWholesalePharmaceuticalCustomer Service
Driving innovation in nuclear medicine to improve patients’ lives
Industry
Pharmaceutical Manufacturing
Company size
1,001-5,000 employees
Founded
2017
Headquarters
Boston, Massachusetts
LinkedIn followers
79,298
Curium is the global leader in nuclear medicine, providing life-changing diagnostics and treatment to patients all over the world.
We develop, manufacture and distribute world-class radiopharmaceutical products with a renewed focus on cancer, exploring untapped potential for new innovation.
We build on remarkable foundations and a legacy of providing reliable and consistent nuclear solutions to tens of thousands of patients every day. Our proven heritage combined with a pioneering approach are the hallmarks from which we provide life-changing diagnostics and therapeutics. Our people are the root of the incredible impact they have.
As part of our 2030 vision to become an oncology-focused nuclear medicine leader – both in diagnostics and therapy – we will expand our reach further into Japan and China, continuing to roll out our superior products to a global market. The impact of these investments on patients will be life changing.
Our cancer focus is currently in Neuroendocrine Tumors (NETs) and prostate cancer PSMA. We are also working on leveraging the power of AI to improve image quality and accuracy; to identify patterns to help diagnose pathologies and of course to better support physicians.
Our Promise
We strive to make the impossible possible and to be an organization that will change the face of medicine. Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply revolutionary diagnostic and therapeutic radiopharmaceuticals to our customers around the globe with unrivaled reliability and superior service.
Offices: 2 Seaport Ln, 2nd floor, Boston, Massachusetts 02210, US · 20, rue Quentin Bauchart, Paris, France 75008, FR · 111 Westport Plaza, Suite 800, St. Louis, MO 63043, US · Biopôle Clermont-Limagne 3 rue Marie Curie 63360, Saint-Beauzire, FR · Westerduinweg 3, Petten, North Holland 1755, NL
Nuclear MedicinePET ImagingMolecular ImagingcGMP ManufacturingContract Manufacturingand SPECT ImagingWholesalePharmaceuticalCustomer Service