Planet Pharma
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Director of Clinical Operations
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Planet Pharma 1 day ago Be among the first 25 applicants Join to apply for the
Director of Clinical Operations
role at
Planet Pharma Get AI-powered advice on this job and more exclusive features. Summary
Job Description
The Director, Clinical Operations contributes to the development and implementation of strategic direction in the conduct of multiple clinical studies. Responsibilities include providing oversight to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements, and leading, building and directing Clinical Operations teams in the management of contract research organizations (CROs) and other trial vendors. Oncology experience is required. The Director contributes Clinical Operations expertise in cross-functional meetings and initiatives. Management, hiring and mentoring of additional Clinical Operations staff is expected.
Position Requirements
Accountable for overall management of multiple clinical trials including:
providing strategic direction to study teams to meet corporate study goals and timelines; reporting and justification of study metrics to executive management, as requested Contributes expertise in all operational activities pertaining to the execution of clinical trials Partners with and maintains regular contact with relevant departments Participates in the selection of Contract Research Organizations (CROs) Attend CRO and other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals Provides consistent, regular oversight of CRO and vendor performance In partnership with Clinical Operations senior management contributes to definition, development and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices Contributing member of various study and program teams such as the Study Management team; provides direction to CTMs in creating meeting agendas and documenting outcomes and deliverables Contributes to the development of staffing/resourcing plans May act as designee for Vice President, Clinical Operations, as appropriate Contributes to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed Travel may be required up to 20% in support of clinical study activities
Supervisory Responsibilities
Will directly supervise employee(s). Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors
Education
BS/BA or MS/MA degree in related discipline
Requirements
Typically requires a minimum of 8-10 years of related experience or a minimum of 12 years combined education/training and experience.
Experience in Biotech/Pharmaceutical industry preferred. Management experience including outsourcing to Contract Research Organizations (CROs).
Cell Therapy experience with Oncology clinical trials is a must
Early Phase clinical trial expertise
Small Biotechnology experience The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Seniority level
Seniority level
Not Applicable Employment type
Employment type
Full-time Job function
Job function
Research, Analyst, and Information Technology Industries
Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Get notified about new Director Clinical Operations jobs in
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Director of Clinical Operations
role at
Planet Pharma 1 day ago Be among the first 25 applicants Join to apply for the
Director of Clinical Operations
role at
Planet Pharma Get AI-powered advice on this job and more exclusive features. Summary
Job Description
The Director, Clinical Operations contributes to the development and implementation of strategic direction in the conduct of multiple clinical studies. Responsibilities include providing oversight to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements, and leading, building and directing Clinical Operations teams in the management of contract research organizations (CROs) and other trial vendors. Oncology experience is required. The Director contributes Clinical Operations expertise in cross-functional meetings and initiatives. Management, hiring and mentoring of additional Clinical Operations staff is expected.
Position Requirements
Accountable for overall management of multiple clinical trials including:
providing strategic direction to study teams to meet corporate study goals and timelines; reporting and justification of study metrics to executive management, as requested Contributes expertise in all operational activities pertaining to the execution of clinical trials Partners with and maintains regular contact with relevant departments Participates in the selection of Contract Research Organizations (CROs) Attend CRO and other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals Provides consistent, regular oversight of CRO and vendor performance In partnership with Clinical Operations senior management contributes to definition, development and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices Contributing member of various study and program teams such as the Study Management team; provides direction to CTMs in creating meeting agendas and documenting outcomes and deliverables Contributes to the development of staffing/resourcing plans May act as designee for Vice President, Clinical Operations, as appropriate Contributes to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed Travel may be required up to 20% in support of clinical study activities
Supervisory Responsibilities
Will directly supervise employee(s). Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors
Education
BS/BA or MS/MA degree in related discipline
Requirements
Typically requires a minimum of 8-10 years of related experience or a minimum of 12 years combined education/training and experience.
Experience in Biotech/Pharmaceutical industry preferred. Management experience including outsourcing to Contract Research Organizations (CROs).
Cell Therapy experience with Oncology clinical trials is a must
Early Phase clinical trial expertise
Small Biotechnology experience The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Seniority level
Seniority level
Not Applicable Employment type
Employment type
Full-time Job function
Job function
Research, Analyst, and Information Technology Industries
Staffing and Recruiting Referrals increase your chances of interviewing at Planet Pharma by 2x Get notified about new Director Clinical Operations jobs in
Germantown, MD . Director of Operations - Home Healthcare
Columbia, MD $80,000.00-$95,000.00 2 weeks ago Senior Operations Manager, Day Shift, Outpatient Imaging
Silver Spring, MD $96,058.56-$145,995.20 5 days ago Director Clinical Documentation Improvement and Integrity, Day Shift, Clinical Documentation
Gaithersburg, MD $127,850.69-$191,776.05 1 month ago Director, Clinical Nutrition, Inova Fairfax Hospital
Senior Global Clinical Operations Program Director
Washington, DC $64,771.00-$80,964.00 9 months ago Germantown, MD $110,000.00-$130,000.00 2 months ago Director, Clinical Nutrition, Inova Fairfax Hospital
Nursing Clinical Director of Operations, Day Shift, Executive Services
Silver Spring, MD $116,227.90-$174,341.84 5 days ago Clinical Associate Director, Adult Program
Bethesda, MD $90,000.00-$112,000.00 4 months ago Washington, DC $114,746.00-$129,090.00 2 months ago Washington, DC $200,000.00-$225,000.00 3 weeks ago Washington, DC $200,000.00-$225,000.00 2 months ago Columbia, MD $142,327.53-$237,190.02 2 months ago Hyattsville, MD $75,000.00-$85,000.00 2 weeks ago Washington, DC $137,550.40-$229,257.60 1 day ago Frederick, MD $20,000.00-$110,000.00 1 month ago Annandale, VA $155,000.00-$175,000.00 4 weeks ago Director, Study Management (Cell Therapy)
Gaithersburg, MD $162,566.41-$243,849.59 2 days ago Assistant Director of Clinical Services Mental Health
Washington, DC $100,000.00-$110,000.00 4 weeks ago Washington, DC $126,000.00-$157,500.00 3 days ago Center Director (BCBA) - Center Based FULL-TIME - Bonus Opportunities up to $24,500 & Sign-On Bonus!!!
Eldersburg, MD $23,500.00-$100,000.00 3 months ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr