Clinical Development Director Jobs

Assoc Clinical Development Director — China - Shanghai. Apply via Workday.

ROLE SUMMARY The Clinician Medical Monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds. In addition to study level activities, the clinician medical monitor may participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews, and aid new business development on market opportunities and the target product profile. ROLE RESPONSIBILITIES Accountable for safety across the study Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the “Safety Data Review Guide – for Clinicians.” Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context required for benefit-risk assessm

Clinical Development Medical, Associate Director — United States - New York - Pearl River. Apply via Workday.

Clinical Development Medical, Associate Director — United States - New York - Pearl River. Apply via Workday.

Clinical Development Medical, Associate Director — United States - New York - Pearl River. Apply via Workday.

Director, Clinical Development Scientist (Non-MD) — 6 Locations. Apply via Workday.

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 We are seeking a highly motivated leader to join us as Executive Director, Clinical Development (MD) in the multiple myeloma disease area. This role will play a key role in development and oversight of cell therapy programs, collaboration with external partners, and support evaluation opportunities for expanding the clinical development program. You will lead a portfolio of clinical trial programs in cell therapy clinical development: Accountable for the design, conduct, evaluation, close-out and reporting of clinical trials across the portfolio. Lead and direct the development, implementation, and execution of the clinical development strategy, which will include development of the Target Product Profile and Clinical Development Plan. Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contribut

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 Key Responsibilities Provide clinical and scientific leadership for one or more inflammation development programs. Develop and continually refine the Clinical Development Plan (CDP), including indication strategy, target populations, clinical sequencing, success criteria, and key development decisions. Lead the design and execution of early- and mid-stage clinical trials, including Phase 1b/2 proof-of-concept and dose-ranging studies. Translate complex immunology and human disease biology into testable clinical hypotheses and development strategy. Integrate clinical, translational, biomarker, pharmacologic, and comp

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 RESPONSIBILITIES: Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products. Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines. Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries. Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance. Manages the clinical development component(s) in the prepar

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 The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Clinical Development organization and aims to unlock the power of Real-World Data (RWD) to help transform innovations to life-changing medicines for patients. We are seeking a Senior Director, RWE Inflammation Product Lead who will be accountable for the development and execution of the RWE strategy in support of one or more Inflammation products under development. The incumbent will serve as the key RWE subject matter expert within Gilead's lifecycle management teams for the product(s) and all its indications across the development lifecycle and serve as a strategic

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 The Oncology Business, Strategy, and Operations Lead will play a pivotal role in supporting the SVP of Oncology Clinical Development in building and executing the strategic vision for the Oncology Therapeutic Area (TA). As Gilead Oncology enters an exciting phase of growth and investment, this position offers the unique opportunity to collaborate directly with senior leadership to advance a world-class clinical development team, build the portfolio, and elevate oncology as a key focus area for Gilead. RESPONSIBILITIES As a member of the Oncology Leadership Team help to design and facilitate

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott , you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year . An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to

ROLE SUMMARY Exciting opportunity in Clinical Pharmacology! Our Clinical Pharmacology Team is looking for an Associate Director to support the exciting portfolio in Internal Medicine. Our team members champion the innovative use of MIDD for efficient drug development and robust decision-making. A great environment for learning and professional growth! Our Clinical Pharmacology Leads have key roles to play in influencing the discovery and development of drugs. Pfizer is a leader in model informed drug discovery and development (MIDD), and we are expanding in influence and impact. We have an open position as Clinical Pharmacology Lead supporting our End-to-End Internal Medicine portfolio. The ideal candidate is responsible for providing the clinical pharmacology and MIDD components of clinical plans and provide clinical pharmacology expertise to the project team and regulatory interactions. Working with multifunctional study team, Clinical Pharmacology Leads utilize innovative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and diseases for rational development strategies and decisions, as well as optimal study designs and dosage regimen selections. ROLE RESPONSIBILITIES Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team and other multifunctional teams as appropriate. Responsible for providing expertise, leadership, and deliverables of clinical pharmacology for the assigned projects within sphere of influence. Design and execute clinical pharmacology plans and implement clinical pharmacology best practices on project teams. Work closely with other disciplines to ensure that sufficient preclinical PK/PD knowledge exists to underwrite safe human administration and to establish the structure of a predictive model prior to FIH. Responsible for planning and overseeing clinical pharmacolo

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 Key Responsibilities: Provides input into strategic and operational short- and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation. Provides leadership, guidance, oversight and therapeutic expertise for the successful management of all aspects of clinical trials. Responsible for the strategic, operational and financial oversight of assigned program(s). Develops, implements, manages and ensures completion of clinical trials within designated budgets and timelines. Sets the strategic vision for assigned clinical trials / programs by working cross

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 Director, Clinical Operations – Oncology We are seeking a strong, experienced Clinical Operations leader for a Director position within our Oncology Group. Clinical Operations is responsible for the worldwide execution of Phase I-IV clinical trials across all Gilead therapeutic areas and plays a key role in ensuring trials are conducted in accordance with applicable SOPs, company policies and regulatory guidelines. This work supports the timely delivery of high-quality clinical data for global registration and commercialization of Gilead’s products. You will typically lead a large team of direct and indirect reports and be accountable for the operatio