Head of Clinical Operations
Job Details
Job Location:
Main Corporate Office - Malvern, PA
Position Type:
Full Time
Salary Range:
Undisclosed
Description
Job purpose
The Head of Clinical Operations will be responsible for the oversight, management, and delivery of clinical trials. This position reports directly to the Chief Medical Officer.
Duties and responsibilities
Provide leadership role in conducting multiple Phase I-IV clinical research trials across all functional areas of the drug development process
Ensure adherence to CRO/Vendor oversight procedures and governance that are used across all programs
Oversee and coordinate the operations aspects of assigned projects and project teams
Lead the selection and negotiation activities related to CROs, vendors and investigator sites as it relates to contracts, work orders and budgets
Review budgets, forecasts and accruals for assigned clinical studies, and ensure that clinical projects remain on schedule and within budget
Responsible for determining and communicating to CMO/Executive Management adequate resource requirements
Be accountable for study execution and report on study progress, timelines, milestones, and challenges
Attend investigator meetings, kick-off meetings and various CRO or other vendor meetings, as required
Liaise with Regulatory Affairs and Quality to assure adherence to GCPs; maintenance of SOPs and assure site and CRO/vendor audits are completed
Maintain strong relationships with Principal Investigators (PI) and study personnel
Hire, develop and retain clinical operations staff as needed
Additional tasks and projects as requested
Qualifications
Bachelor's degree required; advanced degree preferred
10
years of relevant industry experience in clinical/medical research or biotech/pharma; Vaccine product development expertise preferred
7
years leading Clinical Operations, 3 years in a small to mid-size company
Comprehensive understanding of applicable clinical research regulations in multiple regions
Demonstrated management and cross-functional collaboration skills with proven experience to drive productivity, efficiency, and quality
Ability to quickly learn and apply new skills, meet short deadlines and multi-task in a fast-moving environment
Understand and experience in data management, statistics, and project management necessary for successful study execution
Advanced understanding of clinical development
Ability to set priorities, direct multiple projects and implement complex strategies
Excellent analytical and problem-solving skills
Proven negotiating experience with internal and external stakeholders
Working conditions
This position operates in an office setting and may include 20% of travel to visit sites, vendors or CROs.
Physical requirements
This is a largely sedentary role.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.Estimated Salary: $20 to $28 per hour based on qualifications.
Job Location:
Main Corporate Office - Malvern, PA
Position Type:
Full Time
Salary Range:
Undisclosed
Description
Job purpose
The Head of Clinical Operations will be responsible for the oversight, management, and delivery of clinical trials. This position reports directly to the Chief Medical Officer.
Duties and responsibilities
Provide leadership role in conducting multiple Phase I-IV clinical research trials across all functional areas of the drug development process
Ensure adherence to CRO/Vendor oversight procedures and governance that are used across all programs
Oversee and coordinate the operations aspects of assigned projects and project teams
Lead the selection and negotiation activities related to CROs, vendors and investigator sites as it relates to contracts, work orders and budgets
Review budgets, forecasts and accruals for assigned clinical studies, and ensure that clinical projects remain on schedule and within budget
Responsible for determining and communicating to CMO/Executive Management adequate resource requirements
Be accountable for study execution and report on study progress, timelines, milestones, and challenges
Attend investigator meetings, kick-off meetings and various CRO or other vendor meetings, as required
Liaise with Regulatory Affairs and Quality to assure adherence to GCPs; maintenance of SOPs and assure site and CRO/vendor audits are completed
Maintain strong relationships with Principal Investigators (PI) and study personnel
Hire, develop and retain clinical operations staff as needed
Additional tasks and projects as requested
Qualifications
Bachelor's degree required; advanced degree preferred
10
years of relevant industry experience in clinical/medical research or biotech/pharma; Vaccine product development expertise preferred
7
years leading Clinical Operations, 3 years in a small to mid-size company
Comprehensive understanding of applicable clinical research regulations in multiple regions
Demonstrated management and cross-functional collaboration skills with proven experience to drive productivity, efficiency, and quality
Ability to quickly learn and apply new skills, meet short deadlines and multi-task in a fast-moving environment
Understand and experience in data management, statistics, and project management necessary for successful study execution
Advanced understanding of clinical development
Ability to set priorities, direct multiple projects and implement complex strategies
Excellent analytical and problem-solving skills
Proven negotiating experience with internal and external stakeholders
Working conditions
This position operates in an office setting and may include 20% of travel to visit sites, vendors or CROs.
Physical requirements
This is a largely sedentary role.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.Estimated Salary: $20 to $28 per hour based on qualifications.
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