- 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
- 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
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Head of Clinical Operations - Malvern, United States - Ocugen, Inc.
2 weeks ago
Description
Job DetailsJob 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
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.
