Head of Clinical Operations

3 weeks ago

Malvern, United States Ocugen, Inc. Full time

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.

  • Head of U.S. Customer Operations

    2 months ago

    Malvern, United States Zoetis Full time

    States considered: PA, NJ ROLE DESCRIPTION The Head of Customer Operations will operationalize and lead U. S. Commercial support for rebate, pricing, and indirect sales administrative activities across species units (Petcare, Livestock and DX). The role will involve frequent interaction and partnership with key stakeholders across function including...

  • Head Coach Women's Soccer/Operations Manager

    4 weeks ago

    Malvern, United States Immaculata University Full time

    Head Coach Women's Soccer/Operations Manager Category: AdministrativeDepartment: AthleticsLocations: Malvern, PACloses: Open Until FilledType: Full Time ExemptPosition ID: 175700About Immaculata University:Immaculata University is a comprehensive, co-ed institution of higher learning that has emphasized academic success, student outcomes and faith-based...

  • Head Coach Women's Soccer/Operations Manager

    1 month ago

    Malvern, Arkansas, United States Immaculata University Full time

    Head Coach Women's Soccer/Operations ManagerCategory: AdministrativeDepartment: AthleticsLocations: Malvern, PACloses: Open Until FilledType: Full Time ExemptPosition ID: 175700About Immaculata University:Immaculata University is a comprehensive, co-ed institution of higher learning that has emphasized academic success, student outcomes and faith-based...

  • Head Coach Women's Soccer/Operations Manager

    3 weeks ago

    Malvern, Arkansas, United States Immaculata University Full time

    Head Coach Women's Soccer/Operations ManagerCategory: AdministrativeDepartment: AthleticsLocations: Malvern, PACloses: Open Until FilledType: Full Time ExemptPosition ID: 175700About Immaculata University:Immaculata University is a comprehensive, co-ed institution of higher learning that has emphasized academic success, student outcomes and faith-based...

  • Head Coach Women's Soccer/Operations Manager

    7 days ago

    Malvern, Arkansas, United States Immaculata University Full time

    Head Coach Women's Soccer/Operations ManagerCategory: AdministrativeDepartment: AthleticsLocations: Malvern, PACloses: Open Until FilledType: Full Time ExemptPosition ID: 175700About Immaculata University:Immaculata University is a comprehensive, co-ed institution of higher learning that has emphasized academic success, student outcomes and faith-based...

  • Clinical Trial Label Associate

    2 weeks ago

    Malvern, United States Clingen Clinical Supplies Management Full time

    **About Clinical Trial Labels at Clinigen**: Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world. The purpose of this...

  • Head of U.S. Customer Operations

    4 weeks ago

    Malvern, United States Zoetis Full time

    States considered: PA, NJ ROLE DESCRIPTION The Head of Customer Operations will operationalize and lead U. S. Commercial support for rebate, pricing, and indirect sales administrative activities across species units (Petcare, Livestock and DX). The role will involve frequent interaction and partnership with key stakeholders across function including...

  • Labels Design Associate

    6 days ago

    Malvern, United States Clingen Clinical Supplies Management Full time

    **About Clinical Trial Labels at Clinigen**: Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world. The purpose of this...

  • Head Coach

    7 days ago

    Malvern, Arkansas, United States Immaculata University Full time

    Head Coach - Men and Women's Track & Field/Intramural CoordinatorCategory: StaffDepartment: AthleticsLocations: Malvern, PACloses: Open Until FilledType: Full Time ExemptPosition ID: 175683About Immaculata University:Immaculata University is a comprehensive, co-ed institution of higher learning that has emphasized academic success, student outcomes and...

  • Head Coach

    3 weeks ago

    Malvern, Arkansas, United States Immaculata University Full time

    Head Coach - Men and Women's Track & Field/Intramural CoordinatorCategory: StaffDepartment: AthleticsLocations: Malvern, PACloses: Open Until FilledType: Full Time ExemptPosition ID: 175683About Immaculata University:Immaculata University is a comprehensive, co-ed institution of higher learning that has emphasized academic success, student outcomes and...

  • Head of Total Rewards

    7 days ago

    Malvern, Pennsylvania, United States Siemens Full time

    Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique...

  • Director, Clinical Trial Management/Clinical Operations

    4 weeks ago

    Malvern, United States NexEos Bio Full time

    Director, Clinical Trials Management/Clinical OperationsFLSA: ExemptReports to: President, R&DLocation: HybridDate Prepared: 21,05,2024The successful candidate will have demonstrated successful experience managing clinical operations in small or mid-sized CROs and/ or biopharmaceutical companies. Experience in the areas of radiopharmaceutical imaging,...

  • Director, Clinical Trial Management/Clinical Operations

    3 weeks ago

    Malvern, United States NexEos Bio Full time

    Director, Clinical Trials Management/Clinical OperationsFLSA: ExemptReports to: President, R&DLocation: HybridDate Prepared: 21,05,2024The successful candidate will have demonstrated successful experience managing clinical operations in small or mid-sized CROs and/ or biopharmaceutical companies. Experience in the areas of radiopharmaceutical imaging,...

  • Head of Fraud Strategy and Analytics

    4 weeks ago

    Malvern, United States Vanguard Full time

    Vanguard Head of Fraud Strategy and Analytics Malvern , Pennsylvania Apply Now As the Head of Vanguard’s Fraud Strategy and Analytics, you will lead the team responsible for real-time fraud risk mitigation across the enterprise. This team’s roles and responsibilities include ingesting and analyzing the output of AI/ML models and tools, executing...

  • Head of Fraud Strategy and Analytics

    3 weeks ago

    Malvern, United States Vanguard Full time

    Vanguard Head of Fraud Strategy and Analytics Malvern , Pennsylvania Apply Now As the Head of Vanguard’s Fraud Strategy and Analytics, you will lead the team responsible for real-time fraud risk mitigation across the enterprise. This team’s roles and responsibilities include ingesting and analyzing the output of AI/ML models and tools, executing...

  • Head of Data Science

    7 days ago

    Malvern, Pennsylvania, United States Vanguard Full time

    The Center for Analytics and Insights (CAI) at Vanguard is an enterprise center of excellence for Artificial Intelligence, Machine Learning and Advanced Analytics transforming how data, analytics and AI/ML are used to support strategic decisions and serve Vanguard's clients. The CAI's mission is to apply innovative analytical approaches to help tackle...

  • Head of Sales Technology

    4 weeks ago

    Malvern, United States Customers Bank Full time

    At Customers Bank, we believe in working hard, working smart, working together to deliver memorable customer experiences and having fun. Our vision, mission, and values guide us along our path to achieve excellence. Passion, attitude, creativity, integrity, alignment, and execution are cornerstones of our behaviors. They define who we are as an organization...

  • Director, Clinical Wireless Operations

    4 weeks ago

    Malvern, Arkansas, United States Philips Full time

    Job TitleDirector, Clinical Wireless OperationsJob DescriptionDirector, Wireless Operations AM&D Heart (Malvern, PA or Hamilton, NJ)The Director of the Wireless Operations will provide direct and indirect support for our staff at multiple Independent Diagnostic Testing Facilities (IDTF) throughout the United States that provide remote cardiac monitoring...

  • Director, Clinical Wireless Operations

    3 weeks ago

    Malvern, Arkansas, United States Philips Full time

    Job TitleDirector, Clinical Wireless OperationsJob DescriptionDirector, Wireless Operations AM&D Heart (Malvern, PA or Hamilton, NJ)The Director of the Wireless Operations will provide direct and indirect support for our staff at multiple Independent Diagnostic Testing Facilities (IDTF) throughout the United States that provide remote cardiac monitoring...

  • Head of Compensation Consulting, Americas

    7 days ago

    Malvern, Pennsylvania, United States Siemens Full time

    Head of Compensation Consulting, Americas Come join our team in making revolutionary advancements in the healthcare industry. Together, we are dedicated to providing innovative solutions that benefit people around the globe. Our inclusive and supportive community embraces diversity and individuality, empowering you to expand your horizons with the resources...