![Actalent](https://media.trabajo.org/img/noimg.jpg)
Director Of Clinical Operations
2 months ago
Summary of the Essential Functions of the Job :
* Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality
* Ensure operational activities and tactical execution are linked to Program strategy
* Implement strategies and tactics to proactively identify, monitor and resolve project and program risks. Collaborate with cross-functional teams and senior management to resolve complex issues promptly and effectively
* Provide a continuously updated and balanced appraisal of the project and program status, including risk, cost, and value to stakeholders and senior management. Evaluate, highlight, and escalate unresolved issues, potential barriers to program progression and resource constraints
* Assists in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report, and other regulatory documents
* Oversee the development of trial(s) timelines, budget, and priorities
* Establish key performance indicators and metrics for the Clinical Operations
department and use Change Management skills to ensure they are translated into standards
* Ensure robust Sponsor oversight of Service Providers and compliance with FDA regulations, GCP, ICH, and Company SOPs for all clinical operations activities
* Serve as a member of the Clinical Operations Leadership Team (COLT), working in partnership with peers and the VP, Clinical Operations to set the strategy and direction for the department
* When needed, serve as the delegate for the VP, Clinical Operations at strategic meetings. Serve as Signatory coverage, assuming the VP's Grant of Authority for signing contracts and Agreements
* Support business planning as needed, including demand and resource management. Set appropriate and rational headcount/manpower forecasts to support the portfolio of clinical trials
* Support annual Strategic Planning exercise, as needed, including setting internal and external (clinical trial) budget forecasts
* Participate in prioritization exercises to rationalize the clinical projects and non-project initiatives managed on an annual basis
* Collaboratively work with other Functional Areas, as well as cross-functional teams to ensure timely delivery of project deliverables with consistent high performance and quality of work
* Lead the development and optimization of processes for Clinical Operations. Proactively assess and evaluate the need for new/updated processes and manage implementation of process improvement initiatives
* Provide input into strategies for outsourcing partnerships. Participate in the vendor selection and review process. Lead vendor and Site contracting and manage change order processes as needed
* Strong vendor management to hold Service Providers accountable for performance. Serve as key contributor on Sponsor/Service Provider Operational Governance Committee
* Ensure management of clinical study budgets and specifications so that project/study goals are achieved within scope. Assure study priorities are satisfied and budgets are adhered to. Ensure tracking, financial, and resourcing tools are effectively utilized. Support identification and resolution of budget and resourcing issues
* Participate in the development of training programs and manage training initiatives for direct reports. Collaborate with training resources. Document requirements and report completion
* Responsible for objective setting and performance review for direct reports. Identify and address performance issues and training needs at a functional and departmental level. Serve as a resource and mentor to direct reports and other less experienced staff.
Minimum Requirements:
* BS/BA degree or a relevant degree with strong emphasis on science
* Minimum of four years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials
* Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience
* Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
* Demonstrated leadership and problem-solving skills
* Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)
* Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment
* Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently
* Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships
* Minimum of a BSN/RN/BA or BS in a related field. MBA or advanced degree in a scientific discipline is desirable
* 10+ years of progressive R&D Clinical Operations experience at a biotech, pharmaceutical company or clinical CRO; 7+ years leading teams; 5+ years in a Leadership/Strategic role
* Phase 1-4 clinical trial experience required. Experience running pivotal, multi-regional/global clinical trials. Experience leading project operational teams through all stages of the trial (forecasting/planning, start-up, conduct, close-out). Previous monitoring, study coordination, data management and/or clinical project management experience, including vendor/CRO management is required
* Previous supervisory/line management experience
* Strong knowledge of the end-to-end pharmaceutical drug development and commercialization process, including hands-on experience in the successful planning and execution or contribution to complex Health Authority interactions such as End-Of-Phase 2, Advisory Committee meetings, IND, sNDA/NDA submissions, and approvals
* Scientifically and clinically astute with learning agility, translating to a demonstrated ability to develop a deep understanding of therapeutic areas and optimal development strategies
* Advanced knowledge of cGCP, ICH, FDA and EMEA regulatory requirements
* Strong project management, analytical and problem-solving skills.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
* Hiring diverse talent
* Maintaining an inclusive environment through persistent self-reflection
* Building a culture of care, engagement, and recognition with clear outcomes
* Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
We have other current jobs related to this field that you can find below
-
Director of Clinical Psychology
2 months ago
Rockville, United States TLC - The Treatment and Learning Centers, Inc. Full timeJob DescriptionJob DescriptionThe Testing, Tutoring and Counseling Department at TLC -The Treatment and Learning Centers, seeks to hire a full-time Clinical Psychologist for the Director position. This position will oversee and manage the operations of the three teams: assessment, tutoring, and individual, group, and family counseling. The Director is...
-
Director of Clinical Psychology
1 month ago
Rockville, United States Scismic Inc Full timeJob DescriptionJob DescriptionScismic is supporting the growth of a nearly private, non-profit organization located in Rockville, MD that has been serving the community for nearly 75 years. Each year, this organization's programs serve nearly 2,000 individuals with a wide range of different abilities. Their mission is to improve lives and expand...
-
Rockville, United States Association of Community Cancer Centers Full timeDirector of Medical Oncology Operations, Thompson Oncology Group Full Time, 80 Hours Per Pay Period, Day Shift, Travel required to all TOG/TCSC centers as needed. Position Summary: The Director of Medical Oncology Operations for Thompson Cancer Survival Center (TCSC) and Thompson Oncology Group (TOG) is accountable for the financial oversight and...
-
Clinic Director
1 month ago
Rockville, Maryland, 20852, Montgomery County, MD, United States ATI Physical Therapy Full timeOverview: Stronger Together: ATI is the largest outpatient orthopedic physical therapy company under one brand, growing to over 900 locations in 24 states. We continue to preserve our friendly atmosphere with our innovative, vibrant, and team-based culture. Collaboration is at the heart of what we do, and it's guided by our National Outcomes Registry...
-
Deputy Director, Division of Clinical Innovation
3 months ago
Rockville, United States ncats Full timeDescription The National Center for Advancing Translational Sciences (NCATS), a major research component of the National Institutes of Health (NIH), seeks applications from outstanding candidates to be deputy director of the center’s Division of Clinical Innovation (DCI). DCI manages the Clinical and Translational Science Awards (CTSAs) Program. The CTSA...
-
School Director
2 months ago
Rockville, United States Generator Supercenter of Austin Full timeBenefits: Free Uniform Items Team Building Initiative Employee Referral Bonuses Child Care Discounts Paid Holidays Free Continuing Education Units Career Development Benefits may vary by location: Health insurance Paid time off Company parties Competitive salary Free food & snacks Opportunity for advancement Training & development Celebree School of North...
-
School Director
2 months ago
Rockville, United States Celebree School of North Potomac Full timeBenefits: Free Uniform Items Team Building Initiative Employee Referral Bonuses Child Care Discounts Paid Holidays Free Continuing Education Units Career Development Benefits may vary by location: Health insurance Paid time off Company parties Competitive salary Free food & snacks Opportunity for advancement Training & development Celebree School of North...
-
Assistant Director
2 months ago
Rockville, United States Celebree School of North Potomac Full timeJob DescriptionJob DescriptionBenefits:Free Uniform ItemsTeam Building InitiativeEmployee Referral BonusesChild Care DiscountsPaid HolidaysFree Continuing Education UnitsCareer DevelopmentBenefits may vary by location:401(k)Health insurancePaid time offCompetitive salaryTraining & development Celebree School of North PotomacHours: Monday through Friday: 6:30...
-
Medical Director
18 hours ago
Rockville, United States CK Group Full timeDirector/Snr Director, Clinical Development, Melanoma The Director/Snr Director, Clinical Development will be a MD with a specialisation in oncology, ideally board-certified, and a deep understanding of the solid tumor landscape. Those who are well-versed in the current and emerging treatments for melanoma is preferable and have demonstrated the ability to...
-
Medical Director
2 weeks ago
Rockville, United States CK Group Full timeDirector/Snr Director, Clinical Development, Melanoma The Director/Snr Director, Clinical Development will be a MD with a specialisation in oncology, ideally board-certified, and a deep understanding of the solid tumor landscape. Those who are well-versed in the current and emerging treatments for melanoma is preferable and have demonstrated the ability to...
-
Associate Director of Operations
2 months ago
Rockville, United States DSJ Global Full timeA leader in the biopharma industry is seeking an experienced Associate Director of Operations that will provide leadership and management over inbound/outbound distribution and logistics, materials receipt/sampling/inspection, weigh/dispense, materials delivery to manufacturing and bulk drug substance (BDS) freeze-down/storage/shipment to ensure excellent...
-
Associate Director of Operations
2 months ago
Rockville, United States DSJ Global Full timeA leader in the biopharma industry is seeking an experienced Associate Director of Operations that will provide leadership and management over inbound/outbound distribution and logistics, materials receipt/sampling/inspection, weigh/dispense, materials delivery to manufacturing and bulk drug substance (BDS) freeze-down/storage/shipment to ensure excellent...
-
Center Director
2 months ago
Rockville, United States Sunstonetherapies Full timeSunstone Therapies Center Director (Practice Administrator) Rockville, MD·Full time Apply for Center Director (Practice Administrator) Context : Sunstone Therapies is the leader in the delivery of psychedelic-assisted therapy in the medical setting, focusing on the development and implementation of clinical trials today, and moving towards clinical delivery...
-
Associate Director, Supply Chain Operations
2 weeks ago
Rockville, United States Arcellx, Inc. Full timeWho We Are Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are...
-
Associate Director, Supply Chain Operations
1 month ago
Rockville, Maryland, United States Arcellx Full timeWho We AreArcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are...
-
Director, Bioanalytical Immunogenicity
2 weeks ago
Rockville, United States Excelsior Executive Search Full timeDirector – Immunogenicity POSITION SUMMARY: This position is responsible for planning, organizing and directing the overall operation of a GLP/CLIA laboratory, performing assay validations, sample analysis, and laboratory developed tests. This includes maintaining efficient and effective laboratory operations in compliance with all state, federal and...
-
Family Medicine Program Director
2 months ago
Rockville, United States Mid-Atlantic Permanente Medical Group PC Full timeJob DescriptionJob DescriptionThe Mid‐Atlantic Permanente Medical Group (MAPMG) is seeking an American Board of Family Medicine board-certified physician to serve as Program Director for our Family Medicine Residency Program in the Mid‐Atlantic Region. The program director must bring a commitment to and experience in graduate medical education and to the...
-
Audiologist (Director of Audiology)
4 weeks ago
Rockville, United States TLC - The Treatment and Learning Centers Full timeJob Description TLC -The Treatment and Learning Centers in Rockville, MD, seeks to hire a full-time Director for its Audiology Department. This position will develop and manage the diagnostic and rehabilitative services provided by the department, supervising the clinical and support staff and service delivery, provide direct care to patients and market...
-
Director, Bioanalytical Immunogenicity
2 weeks ago
Rockville, United States Excelsior Executive Search Full timeDirector – Immunogenicity Check below to see if you have what is needed for this opportunity, and if so, make an application asap. POSITION SUMMARY: This position is responsible for planning, organizing and directing the overall operation of a GLP/CLIA laboratory, performing assay validations, sample analysis, and laboratory developed tests. This includes...
-
Rockville, United States EGA Associates Full timeJob DescriptionJob DescriptionWe are hiring a Director of clinical Psychology to work at an outpatient pediatric facility. This is a permeant full time position that offers excellent salary with benefits including retirement, vacation, sick time, short term disability, long term disability. Ideal candidate will have several years of experience in supervision...