Urwah Admin

Gilead Sciences

<div><div>At Gilead, we&rsquo;re creating a healthier world for all people. For more than 35 years, we&rsquo;ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer &ndash; working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world&rsquo;s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.</div><div><br>
Every member of Gilead&rsquo;s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we&rsquo;re looking for the next wave of passionate and ambitious people ready to make a direct impact.</div><div><br>
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 Gilead and help create possible, together.<br>
<br>
Job Description</div><div><br>
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.</div><div></div><div>
We set and achieve bold ambitions in our fight against the world&rsquo;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.</div><div></div><div>
As a Senior Scientist, Stability at Gilead you will be vital for the success of Clinical Biologics QC, providing strategic leadership and overseeing daily operations for stability.</div><div></div><div>
Focus Areas:</div><ul><li><div>
Manage stability strategy for assigned products. Coordinate and oversee GMP stability studies for clinical and commercial products, ensuring compliance with FDA, ICH, and global regulatory requirements.</div></li><li><div>
Manage stability study setup and execution, including protocols, storage conditions (ICH long-term, intermediate, accelerated), pull schedules, testing panels, and acceptance criteria.</div></li><li><div>
Oversee stability sample management, including receipt, labeling verification, controlled storage, chain of custody, and timely sample pulls.</div></li><li><div>
Monitor stability chamber conditions (temperature/humidity), support maintenance and qualification activities, and manage excursions and related investigations.</div></li><li><div>
Compile, review, trend, and statistically analyze stability data to identify product risks and support shelf-life assignments, APR/PQRs, and regulatory submissions.</div></li><li><div>
Maintain stability programs and records in electronic systems.</div></li><li><div>
Author and review stability sections of regulatory submissions</div></li><li><div>
Review and manage deviations, OOS/OOT results, risk assessments, and CAPAs.</div></li><li><div>
Ensure inspection readiness and support internal and external audits.</div></li><li><div>
Author, review, and maintain GMP documentation, including protocols, reports, SOPs, deviations, change controls, CAPAs, and study closeout documentation.</div></li><li><div>
Collaborate cross functionally with Quality Control, Quality Assurance, Analytical Development, CMC, Regulatory Affairs, Manufacturing, and Supply Chain to support stability commitments, filings, and health authority responses.</div></li></ul><div></div><div>
Qualifications:</div><ul><li><div>
Experience with Biologics Quality Control with knowledge of industry best practices and trends for Stability.</div></li><li><div>
In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.</div></li><li><div>
Must be able to develop and improve complex concepts, techniques, standards and new applications based on quality principles and theories. Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovation.</div></li><li><div>
Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.</div></li><li><div>
Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.</div></li><li><div>
Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.</div></li><li><div>
Demonstrated the ability to influence process and outcomes across functions.</div></li></ul><div></div><div>
Requirements:</div><ul><li><div>
8+ Years experience with BS in Chemistry, Biochemistry or related field OR</div></li><li><div>
6 + Years with MS in Chemistry, Biochemistry or related field OR</div></li><li><div>
2+ Years with PhD in Chemistry, Biochemistry or related field</div></li><li><div>
Deep knowledge and experience in Biologics quality control.</div></li><li><div>
Stays ahead of shifting trends in industry.</div></li><li><div>
Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.</div></li><li><div>
Strong organizational and planning skills.</div></li><li><div>
Shows excellent verbal and written communication skills and collaborative interpersonal skills.</div></li></ul><div></div><div>
People Leader Accountabilities:</div><ul><li><div>
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.</div></li><li><div>
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.</div></li><li><div>
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.</div></li></ul><br>
<div></div>
The salary range for this position is: $169,320.00 - $219,120.00. Gilead 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*.<div></div><div>
For additional benefits information, visit:</div><div><div>
https://www.gilead.com/careers/compensation-benefits-and-wellbeing</div></div><div></div><ul><li>Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.</li></ul><div><br>
For jobs in the United States:</div><div>
Gilead Sciences Inc. 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 <div>ApplicantAccommodations@gilead.com</div> for assistance.</div><div><br>
For more information about equal employment opportunity protections, please view the <div>'Know Your Rights'</div> poster.</div><div></div><div><div>
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT</div><br>
<div>YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT</div></div><div><br>
Gilead Sciences 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.</div><div><br>
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.</div><div><br>
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.</div><div><br>
For Current Gilead Employees and Contractors:</div><div>
Please apply via the Internal Career Opportunities portal in Workday.</div></div>

Senior Scientist, Stability

<div><div>At Gilead, we&rsquo;re creating a healthier world for all people. For more than 35 years, we&rsquo;ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer &ndash; working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world&rsquo;s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.</div><div><br>
Every member of Gilead&rsquo;s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we&rsquo;re looking for the next wave of passionate and ambitious people ready to make a direct impact.</div><div><br>
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 Gilead and help create possible, together.<br>
<br>
Job Description</div><div><br>
We have an exciting opportunity within our Medical Affairs team based in Saudi Arabia for Kite Middle East Medical Lead.</div><div>
The Middle East Medical Lead (Asso. Director /Director- dependent on experience) will have overall responsibility for building and overseeing the strategies and tactics for Cell Therapy within the Kite Middle East Medical Affairs Department, providing strategic leadership for all Medical Affairs activities and developing and executing Medical Affairs strategic initiatives in the Middle East. This position will report to the Kite International Region Head of Medical Affairs.</div><div></div><div>
Everyone at Kite is grounded by one common goal &ndash; curing cancer. We are at the forefront of immunotherapy and engineered T cell therapy. Our personalized approach is what sets us apart. Unlike traditional pharmaceutical manufacturing, our therapies are not created on an assembly line. With CAR T-cell therapy, we are reengineering a patient&rsquo;s own immune cells to fight cancer &mdash; one patient at a time. We also are entering a pivotal time in our history with multiple planned launches and evolving competitive dynamics on a global scale. That means a fast moving, constantly changing environment and innovative culture, where we make discoveries every day &ndash; discoveries that include our own capabilities and our individual potential.</div><div>
Specific Job Requirements:</div><ul><li>
Provides local medical expertise input into global product development for Kite.</li><li>
Represents the company to groups of experts, medical professional groups, societies, regulatory groups at international scientific meetings and national scientific meetings.</li><li>
Develops and leads plans with national/Middle East region cooperative groups to define what are the gaps and potential specific national requirements/needs. Supports the development of local complex clinical data through clinical trials and investigator studies. Supports the development of Health Economic Outcome Research programs for the country.</li><li>
Contributes to the development of the Market access strategy in coordination with the Market Access, Regulatory affairs, Business Unit Director; deliver the medical part of the plan</li><li>
Manage the Middle East Medical Affairs function</li><li>
Develop and execute Medical pre-launch and post-launch Medical plan</li><li>
Medical Budget oversight/control (+/-5% spent)</li><li>
Provides Medical strategic direction and vision and works as a team with the Business Unit Director and Market Access Director.</li><li>
Be part of the International region Medical Affairs Leadership Team and contribute to the overall International region strategy and efforts.</li><li>
Data generation project where applicable</li><li>
Regular communication with external medical community to remain abreast of issues in the field and to provide medical support and direction to them.</li><li>
Engage in peer to peer scientific exchange of complex clinical and scientific information</li><li>
Develop and foster strong scientific relationships with Thought Leaders (TLs), disease experts, and other health care providers (HCPs)</li><li>
Provide clinical/scientific presentations to internal and external groups</li><li>
Compliantly provide internal teams with feedback and insights from interactions and discussions with HCPs<br>
Engage in accrual enhancement activities with clinical trial sites</li><li>
Provide support at professional meetings, including staffing exhibits, reporting on scientific sessions, and facilitating meetings with TLs and HCPs</li><li>
Adhere to corporate and health care compliance guidance in all activities, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information</li><li>
Maintain clinical, scientific, and technical expertise in hematology/oncology and the company&rsquo;s therapeutic areas of interest</li><li>
Establish and maintain ongoing long-term collaborative relationships with HCPs (including physicians, nurses, and other allied health professionals) within assigned territory</li><li>
Respond to and document unsolicited requests for scientific information</li><li>
Provide clinical input and training to internal functions as requested</li><li>
Provide support for content development and delivery of clinical presentations at Advisory Boards, as requested</li><li>
Work closely with other field-based employees and headquarters-based staff to rapidly respond to questions from sites</li><li>
Attends most major conferences and helps coordinate Medical Affairs activities at conferences and may present to external audience</li><li>
Responsible for the development and execution of projects that will provide more extensive background, additional data or answers to questions in response to issues that arise relative to commercial, scientific or data needs.</li><li>
Performs medical review at Promotional Review Committees.</li><li>
Manages projects to completion, anticipating obstacles and difficulties that may arise, resolving them in a collaborative manner.</li></ul><div>
Knowledge, Experience and Skills:</div><ul><li>
The ideal candidate will have an advanced degree (e.g. MD, PharmD, PhD, etc.) with significant clinical and research experience in the key therapeutic areas.</li><li>
Industry experience is essential with proven Medical Affairs experiences (7+ years), ideally including recent experience of a successful launch within oncology or hematology.</li><li>
CAR-T therapy experience will be an advantage</li><li>
Must have demonstrated organizational skills to manage multiple projects simultaneously.</li><li>
Must demonstrate strong written and verbal communication skills along with excellent judgment and ability to work in a team environment.</li><li>
Strong presentation skills are required.</li><li>
Prior supervisory/leadership experience.</li><li>
Ability to travel to domestic and international conferences which will include occasional weekend travel is required.</li><li>
Language: Fluent in Arabic and professional level English</li></ul><div></div><div><br>
For Current Gilead Employees and Contractors:</div><div>
Please apply via the Internal Career Opportunities portal in Workday.</div></div>

Medical Affairs Lead - Middle East - Kite

Join Gilead Sciences and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Gilead Sciences

About Company

Senior Scientist, Stability

Medical Affairs Lead - Middle East - Kite