Senior Director, Patient Safety (MD)

Kite Pharma; San Francisco (CA); On-site; USD 255,000 - 364,000; Full time

Job summary

Kite Pharma is a biopharmaceutical company focused on cancer immunotherapies and CAR T-cell approaches. We seek an experienced Senior Pharmacovigilance Leader to drive global safety strategy, regulatory input, and risk management for multiple products.

You will lead PV activities and collaborate across functions to ensure compliant safety practices. Ideal candidates hold an MD or equivalent with 12+ years in drug safety, strong leadership, and deep knowledge of EU/FDA PV guidelines.

Qualifications

• MD degree or equivalent with board-eligible status.
• 12+ years of drug safety or clinical practice with PV expertise.
• Strong knowledge of EU and FDA PV guidelines and GCP.
• Proven leadership, problem solving, organization, and planning.
• Excellent written and verbal communication skills.
• Proficiency with MS Word, Excel, and PowerPoint.

Responsibilities

• Provide medical strategy and input into regulatory decisions for safety of multiple products.
• Establish global pharmacovigilance direction and leadership for safety.
• Oversee surveillance, aggregate review and risk management planning.
• Collaborate on safety signals, trends, and management of issues.
• Execute process changes per GVP and regulatory guidance.
• Participate in SOP updates, audits, and data analysis activities.
• Communicate pharmacovigilance findings to senior management.
• Provide global medical leadership for product safety activities.
• Offer strategic input to mitigate pharmacovigilance risk.

Skills

Leadership

Communication

Pharmacovigilance

Regulatory knowledge

Problem solving

Data analysis

Education

MD Degree or equivalent; board eligible

Board certification

Tools

MS Office

Job description

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

Key Responsibilities

• Provides medical strategy and input into key regulatory decisions pertaining to safety of multiple products , including representing safety at advisory panels and meetings with regulators or other internal and external stakeholders.
• Establishes the direction for pharmacovigilance activities for assigned products and provides global medical leadership and input into all aspects of safety for assigned molecule or therapeutic area including surveillance
• programs, aggregate review and risk management planning
• Collaborates with drug safety's risk management team in proactive identification and assessment of safety signals and trends, and supports management of any potential safety issues
• Executes process change and initiatives based on deep understanding of GVP and other regulatory guidance
• Participates in SOP updates, audits, data analysis and other ad hoc activities
• Communicates to highest levels of senior management key pharmacovigilance findings
• Provides global medical leadership for product focused safety activities
• Provides global strategic input to organization to mitigate pharmacovigilance-related risk

Minimum Qualifications

• MD Degree or equivalent; board eligible plus 12 years of relevant experience
• 8+ years of drug safety/pharmaceutical industry or clinical practice experience with extensive PV expertise in one or more therapeutic area
• Significant knowledge of EU and FDA PV guidelines, GCP and clinical research methodology
• Extensive and demonstrated leadership including problem solving, negotiation, organization and planning skills
• Demonstrated effective written and verbal communication skills
• Proficiency with MS Word, Excel, and PowerPoint
• Proven scientific/clinical and analytical knowledge base with ability to assess data and understand the safety/medical implications
• Solid understanding of pharmacoepidemiology and ability to provide sound critique of observational studies

Preferred Qualifications

• MD Degree or equivalent; board certification plus 12 years of relevant experience
• Oncology or Immunology experience
• CarT experience

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.

The salary range for this position is:

Other US Locations: $255,425.00 - $330,550.00.

Bay Area: $281,010.00 - $363,660.00.

Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

For jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.