Sr Clinical Trials Manager

Kite Pharma

1d

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Requirements

• 8+ years of experience and a BS or BA in a relevant scientific discipline OR 8+ years of experience and an RN (2 or 3 year certificate).
• Excellent interpersonal skills and demonstrated ability to lead is required.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Strong communication and influence skills and ability to create a clear sense of direction is necessary.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
• Experience in developing RFPs and selection and management of CROs/vendors.
• Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
• Travel is required.

Nice To Haves

• Ability to examine functional issues from a broader organizational perspective.
• People Leader Accountabilities: •Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. •Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. •Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Responsibilities

• In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
• Coaches members of a work team and ensures adherence to established guidelines.
• Provides input to program budget and timelines to ensure successful management of all aspects of international clinical trials.
• Anticipates obstacles and client difficulties and implements solutions to achieve project goals.
• Assists CPM in revising project timelines/budgets as necessary.
• Works with management on departmental issues, providing input to clinical operations strategies and work plans.
• Communicates with functional peers regarding project status and issues and ensure project team goals are met.
• Contributes to development of abstracts, presentations and manuscripts.
• Participate in the recruiting and hiring process for CPA/CRAs and support their professional development.
• Participate in training of CPAs and CRAs.
• Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level