Clinical Program Manager

Kite Pharma • Santa Monica, CA

4h

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. Job Description At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As the Clinical Program Manager you will...

Requirements

• 8+ Years with BS/BA OR 6+ Years with MS/MA or MBA

Nice To Haves

• BA / BS / RN with 8 or more years’ relevant clinical or related experience in life sciences. Or, MA / MS / PharmD / PhD with 6 or more years’ relevant clinical or related experience in life sciences.
• Typically has a minimum of 4 years’ cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing study management or project teams.
• Relevant clinical trial experience in the pharmaceutical industry.
• Experience in oncology and/or ATIMP clinical trials preferred.
• Experience in Phase IV clinical trials including post marketed required studies advantageous.
• Solid line management experience, including recruiting, managing team members as well as mentoring and developing junior staff preferred.
• Experience in clinical study management and project oversight is essential including timeline and budget management
• Experience in developing RFPs, selection and management of CROs/vendors.
• Ability to write study protocols, study reports, sections for investigator brochures and regulatory documents with minimal supervision
• Excellent interpersonal skills and demonstrated ability to lead is required
• Strong communication, influencing skills and ability to create a clear sense of direction is necessary
• Fluency in English, including both oral and written communications.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Extensive knowledge of ICH GCP and GVP, FDA and EMEA regulations & guidelines.
• Knowledge of drug development & commercialization processes.
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
• Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.
• Must meet all requirements for the position and have demonstrated proficiency in all relevant areas.
• When needed, ability to travel
• 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

• Typically manages a team of direct reports and may have indirect reports.
• Hires, develops and retains diverse top talent on the team.
• Sets clear goals for the team and individuals direct reports.
• Coaches direct reports on their performance, development and career interests.
• Acts as team leader and builder; providing guidance and oversight for the successful management of all aspects of clinical trials within designated program budgets and timelines.
• Leads cross-functional Study Management Teams (SMTs) and influences all relevant stakeholders.
• Ensures successful planning and execution of global and regional Late Phase studies: Including post-marketing required safety/effectiveness studies.
• Partners with cross-functional teams to manage, adjust and revise project timelines and budgets as needed.
• Communicates project status and issues and ensures project team goals are met in alignment with project decisions.
• Escalates issues as needed.
• Participates in the development of all study-related documentation, including study protocols.
• Participates in the selection and management of contract research organizations (CROs) / vendors, including development of requests for proposals (RFPs).
• Anticipates obstacles and difficulties and implements solutions to achieve project goals, including risk assessment and mitigation strategies.
• Resolves issues as needed within national and international regulations and guidelines.
• Uses all available tools to track, oversee and communicate on program status to all key stakeholders.
• Participates in and/or leads departmental or interdepartmental strategic initiatives.
• As assigned, initiates, authors or otherwise contributes to standard operating procedure (SOP) development, implementation and training.
• Ensures team’s work complies with established practices, policies and processes, and any regulatory or other 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.

What This Job Offers

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