At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – 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’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’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’re looking for the next wave of passionate and ambitious people ready to make a direct impact. 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. **Job Description** **Executive Director, Formulation and Process Development** + The Executive Director of Formulation and Process Development will be responsible for leading the development and commercialization of small molecule drug product including proteins/peptides from drug discovery to product commercialization. In addition, the incumbent will be a member of the Technical Development Leadership Team, that is responsible for providing leadership and decisions on the development and commercialization strategies of all modalities. **Responsibilities:** + Provide leadership and direction to the Formulation and Process Development organization, a department of >70 scientists for small molecule formulations including oral solid dosage forms and sterile injectables + Responsible for the design & development of products for all small molecule, peptides, and synthetic oligonucleotides NMEs from lead optimization to commercialization Provide technical, operational, and strategic guidance on a wide range of activities across all development stages (lead optimization of pre-clinical drug candidates, preformulation, formulation development, process scale-up, technology transfer, process validation of clinical drug candidates, and commercial support) + Demonstrate a thorough understanding of the cGMP environment (internal and external cGMP manufacturing operations) and compliance requirements. + Provide guidance and strategic directions through interactions with each formulation and process development (FPD) team + Ensure successful transfer of new products and technology to internal and external clinical and commercial manufacturing sites, including generation of knowledge and understanding to support product robustness targets + Serve as a senior member of the Technical Development Leadership Team responsible for developing and establishing small molecule strategy + Evaluate and implement new technologies to drive innovation in Formulation and Process Development for small molecules + Drive development and implementation of new systems to improve project execution and data management + Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio Management, Finance and Supply Chain, + Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and Clinical Supply Management and Product Strategy Teams by providing technical and strategic input + Hire, mentor and develop team members within the organization + Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections + Provide technical support to internal and external cGMP manufacturing operations + Develop and manage department budget **Qualifications:** + Ph.D. in pharmaceutical sciences or related sciences with at least 15 years of experience in pharmaceutical development and a record of roles with increasing responsibility + In-depth knowledge and understanding of drug product development, commercial technology transfer to manufacturing, CMC related FDA and international regulations + Previous success working effectively in a multidisciplinary, highly matrixed environment + Demonstrated ability to build a team and develop a high performing organization + Excellent decision-making, written and verbal communication skills + Proven ability to lead high performing teams + Exceptional interaction, leadership and command skills are required + Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence. **People Leader Accountabilities:** + Create Inclusion - knowing the business value of diverse teams, modelling 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, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. **Gilead Core Values** • Integrity (Doing What’s Right) • Inclusion (Encouraging Diversity) • Teamwork (Working Together) • Excellence (Being Your Best) • Accountability (Taking Personal Responsibility) As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 careers@gilead.com for assistance. Job Description Translation The salary range for this position is: $281,010.00 - $363,660.00. 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*. 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. **For jobs in the United States:** 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 ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf) YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) 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. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.