Associate Director, Clinical Operations, Oncology
5 months ago
**The Role**:
Moderna is seeking an Associate Director of Clinical Operations to manage studies within the Oncology Therapeutic Area. This may include more than one study. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Director, Clinical Operations. This position will work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects.
**Here’s What You’ll Do**:
Accountable for delivery of assigned clinical study budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Lead and other relevant stakeholders
Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs
Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
Support the selection, oversight, and management of CROs and other vendors
Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Manage the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations
Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures
Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders
Perform and document study level Sponsor Oversight of outsourced clinical activities
Communicate study-status, cost and issues to ensure timely decision-making by senior management
Manage invoice and budget tracking for individual studies and provide input into monthly and annual forecasting activities for studies and programs
Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna
Support program level deliverables/activities at the discretion of the Senior Director, Clinical Operations
Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise
Strive for continuous improvement and more efficient ways of working in clinical development
Act as a role model for Moderna’s values
**Here’s What You’ll Bring to the Table**:
Minimum of BA/BS with at least 8-10 years of trial and clinical program experience, including at least 4 years of independent clinical trial management experience and full trial life cycle experience (e.g., start-up, conduct, closure). Advanced degree preferred.
Robust experience in oncology required. Experience in early clinical development and immuno-oncology desirable. Experience in hematologic malignancies desirable.
Cross-Collaboration proficiency with other functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
Experience in GCP inspections/audits
Outstanding verbal and written communication skills, in addition to excellent organizational skills
Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
Resilient, Creative, capable problem-solver
Excellent organizational skills and ability to work independently
Experience in establishing and maintaining relationships with key opinion leaders
Some travel required
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle
-
Clinical Oncology Pharmacist
2 days ago
Oxford, United Kingdom Nuffield Health The Manor Hospital Full timeKey Responsibilities:As a Clinical Oncology Pharmacist at Nuffield Health Oxford, you will:Patient Care:Screen SACT prescriptions and plan & order treatments for patients.Collaborate with healthcare professionals to optimize pharmaceutical care for oncology patients.Conduct medication reviews and create personalized care plans.Medication Management:Manage...
-
Clinic Support Worker
4 months ago
Oxford, United Kingdom Nuffield Health Full timeNURSING Clinic Support Worker - Oncology Clinic Support worker Oxford Hospital | Oncology | Permanent | Part time Salary up to £33,000 pro rata depending on skills and experience Circa 24 hours per week Nuffield Health is looking for an enthusiastic and committed Healthcare support worker for the Oncology Unit in Oxford. We are looking to find an...
-
Oncology Pharmacist
1 month ago
Oxford, United Kingdom CV-Library Full timeAbout Us Evergood Associates is a leading healthcare Agency committed to delivering exceptional candidates to the NHS and Privet Sector. We are seeking a highly skilled and compassionate Oncology Pharmacist to join our dedicated Pharmacy team to work in a Privet Hospital Based in Oxford. Responsibilities * Provide comprehensive pharmaceutical care to...
-
Oncology Pharmacist
7 days ago
Oxford, Oxfordshire, United Kingdom Nuffield Health Full timeJob DescriptionOncology PharmacistNuffield Health Oxford The Manor Hospital | PharmacyFixed Term Contract (12 Months) | Full-Time (37.5 Hours)£55,770 (DOE)At Nuffield Health, our approach is to fully integrate medicines into a personalized pathway of patient care. As an Oncology Pharmacist, you will be responsible for the following:Patient Care:Clinically...
-
Oncology Pharmacist
3 weeks ago
Oxford, United Kingdom Evergood Associates Full timeAbout UsEvergood Associates is a leading healthcare Agency committed to delivering exceptional candidates to the NHS and Privet Sector. We are seeking a highly skilled and compassionate Oncology Pharmacist to join our dedicated Pharmacy team to work in a Privet Hospital Based in Oxford.Responsibilities * Provide comprehensive pharmaceutical care to patients...
-
Associate Director, Medical Writing Lead
4 weeks ago
Oxford, Oxfordshire, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director, Medical WritingJob Summary:Cpl Life Sciences is seeking an experienced Associate Director, Medical Writing to join our team. As a key member of our Medical Writing department, you will be responsible for leading the planning and authoring of complex clinical and regulatory documents, including clinical trial protocols,...
-
Associate Director, Medical Writing Lead
4 weeks ago
Oxford, Oxfordshire, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director, Medical WritingJob Summary:Cpl Life Sciences is seeking an experienced Associate Director, Medical Writing to join our team. As a key member of our Medical Writing department, you will be responsible for leading the planning and authoring of complex clinical and regulatory documents, including clinical trial protocols,...
-
Oncology Pharmacist
1 month ago
Oxford, United Kingdom Evergood Associates Part timeAbout Us Evergood Associates is a leading healthcare Agency committed to delivering exceptional candidates to the NHS and Privet Sector. We are seeking a highly skilled and compassionate Oncology Pharmacist to join our dedicated Pharmacy team to work in a Privet Hospital Based in Oxford. Responsibilities Provide comprehensive pharmaceutical care to patients...
-
Oxford, Oxfordshire, United Kingdom Oxford University Hospitals NHS Foundation Trust Full timeJob SummaryWe are seeking a highly skilled and motivated Clinical Fellow to join our team in Gynaecological Oncology at Oxford University Hospitals NHS Foundation Trust.Main DutiesThe successful candidate will be responsible for working alongside our experienced Gynaecological Oncology team, providing comprehensive training in Gynaecological Oncology...
-
Oxford, Oxfordshire, United Kingdom Oxford University Hospitals NHS Foundation Trust Full timeJob SummaryWe are seeking a highly skilled and motivated Clinical Fellow to join our team in Gynaecological Oncology at Oxford University Hospitals NHS Foundation Trust.Main DutiesThe successful candidate will be responsible for working alongside our experienced Gynaecological Oncology team, providing comprehensive training in Gynaecological Oncology...
-
Oxford, Oxfordshire, United Kingdom Oxford University Hospitals NHS Foundation Trust Full timeJob SummaryWe are seeking a highly skilled and motivated Clinical Fellow to join our team in Gynaecological Oncology at Oxford University Hospitals NHS Foundation Trust.Main DutiesThe successful candidate will be responsible for working alongside our experienced Gynaecological Oncology team, providing comprehensive training in Gynaecological Oncology...
-
Oxford, Oxfordshire, United Kingdom Oxford University Hospitals NHS Foundation Trust Full timeJob SummaryWe are seeking a highly skilled and motivated Clinical Fellow to join our team in Gynaecological Oncology at Oxford University Hospitals NHS Foundation Trust.Main DutiesThe successful candidate will be responsible for working alongside our experienced Gynaecological Oncology team, providing comprehensive training in Gynaecological Oncology...
-
Associate Director, Medical Writing Lead
2 weeks ago
Oxford, Oxfordshire, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director, Medical WritingJob Type: Permanent, full-timeLocation: Oxford, UK – Hybrid/RemoteRemuneration: Attractive salary and packageAbout the RoleThis is an exciting opportunity for an experienced Medical Writer to join a growing biotechnology company at the forefront of Oncology innovation within Radiopharmaceuticals. As an...
-
Oxford, Oxfordshire, United Kingdom Oxford University Hospitals NHS Foundation Trust Full timeJob SummaryWe are seeking a highly skilled and motivated Clinical Fellow to join our team in Gynaecological Oncology at Oxford University Hospitals NHS Foundation Trust.Main DutiesThe successful candidate will be responsible for working alongside our experienced Gynaecological Oncology team, providing comprehensive training in Gynaecological Oncology...
-
Oxford, Oxfordshire, United Kingdom Oxford University Hospitals NHS Foundation Trust Full timeJob SummaryWe are seeking a highly skilled and motivated Clinical Fellow to join our team in Gynaecological Oncology at Oxford University Hospitals NHS Foundation Trust.Main DutiesThe successful candidate will be responsible for working alongside our experienced Gynaecological Oncology team, providing comprehensive training in Gynaecological Oncology...
-
Oxford, Oxfordshire, United Kingdom Oxford University Hospitals NHS Foundation Trust Full timeJob SummaryOpportunity for Comprehensive Training in Gynaecological OncologyOxford University Hospitals NHS Foundation Trust is seeking a highly motivated and experienced Clinical Fellow to join the Gynaecological Oncology team. This is an exciting opportunity to work in a large tertiary cancer centre, providing comprehensive training in Gynaecological...
-
Oxford, Oxfordshire, United Kingdom Oxford University Hospitals NHS Foundation Trust Full timeJob SummaryOpportunity for Comprehensive Training in Gynaecological OncologyOxford University Hospitals NHS Foundation Trust is seeking a highly motivated and experienced Clinical Fellow to join the Gynaecological Oncology team. This is an exciting opportunity to work in a large tertiary cancer centre, providing comprehensive training in Gynaecological...
-
Oxford, Oxfordshire, United Kingdom Oxford University Hospitals NHS Foundation Trust Full timeJob SummaryClinical Fellow in Gynaecological OncologyOxford University Hospitals NHS Foundation Trust is seeking a highly skilled and motivated Clinical Fellow in Gynaecological Oncology to join our team at the Oxford Gynaecological Cancer Centre. This is an exciting opportunity to work in a large tertiary cancer centre, providing comprehensive training in...
-
Associate Director, Medical Writing Lead
3 weeks ago
Oxford, Oxfordshire, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director, Medical WritingJob Type: Permanent, full-timeLocation: Oxford, UK – Hybrid/RemoteRemuneration: Attractive salary and packageCpl Life Sciences is seeking an experienced Medical Writer to join our team as an Associate Director, Medical Writing. As a key member of our Medical Writing department, you will be responsible for...
-
Associate Director, Medical Writing Lead
3 weeks ago
Oxford, Oxfordshire, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director, Medical WritingJob Type: Permanent, full-timeLocation: Oxford, UK – Hybrid/RemoteRemuneration: Attractive salary and packageCpl Life Sciences is seeking an experienced Medical Writer to join our team as an Associate Director, Medical Writing. As a key member of our Medical Writing department, you will be responsible for...
