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We Are Teva We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. Our Team, Your Impact We are seeking a highly motivated and experienced DMPK Project Leader to join our dynamic R&D team. This individual will lead DMPK strategy and execution across a diverse portfolio, including small molecules for movement disorders, neurodegenerative diseases and biologics such as monoclonal and bispecific antibodies. The ideal candidate will bring deep scientific expertise, strategic thinking, and cross-functional leadership to advance our drug discovery and development programs. How You’ll Spend Your Day • Design, oversee, and interpret in vitro and in vivo ADME/PK studies, including studies tailored to the unique properties of small molecules and biologicals. • Data Analysis and Modeling: Analyze and interpret PK/TOX and ADME data using industry-standard tools, including human PK predictions and clinical translation, to inform drug development decisions • CRO Management and Oversight: Build strong relationships with external CROs, ensuring study quality, compliance with regulatory standards, and alignment with IND-enabling requirements • Author and review DMPK sections of regulatory documents and respond to regulatory agency queries as a subject matter expert. • Cross-Functional Collaboration: Collaborate closely with discovery, toxicology, pharmacology and early clinical teams, to provide guidance on PK/TOX strategies and data interpretation, enhancing overall drug discovery efforts • Innovation and Technology Integration: Work with early and preclinical development teams to integrate cutting-edge technologies and methodologies, driving the innovation of PK and toxicology assessments to expand the drug discovery pipeline Your Skills and Experience • PhD in Pharmaceutical Sciences, Medicinal Chemistry or related field. • Minimum 4 years of industry experience in DMPK, with a proven track record in small molecule and biologic drug development. • Expertise in drug metabolism and impact on drug-drug interaction potential is highly desirable • Understanding of monoclonal and bispecific antibody pharmacokinetics, including FcRn interactions, target-mediated drug disposition, and immunogenicity considerations. • Experience with regulatory submissions and GLP-compliant studies. • Excellent communication skills with the ability to present complex data to diverse audiences. • Collaborative approach and project management skills. Also Good to Have • Familiarity with bioanalytical assay development for both small and large molecules. • Prior involvement in first-in-human studies and clinical pharmacology planning. • Experience in regulatory support of marketed products and life-cycle management How We’ll Take Care of You At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. Already Working @Teva? Make sure to apply through our internal career site on Twist—your one-stop shop for career development Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
We Are Teva We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. Our Team, Your Impact As a Global Program Associate Director (GPAD) within the Global Program Leadership (GPL) organization in Teva R&D, you will act as the operational “engine” of cross‑functional drug development team(s), ensuring alignment, timeline integrity, risk management, and execution across R&D, commercial and TGO functions. You will represent the best interests of the program and as such will be a key point contact within the business. You will drive the program operations, build and maintain detailed project plans, track milestones, risks, and budgets. Tasked with tactical execution, you will be responsible for the use and adherence to program tools & templates, preparing dashboards and reports for governance, supporting meeting logistics and documentation. How You’ll Spend Your Day Strategic partnering: •Partner with the Global Program Team Director (GPTD) and Global Program Team (GPT) members to translate program strategy into actionable global integrated Asset plans (IAPs). •Coordinate preparation and compilation of strategic documents and preparations for program stage gates (endorsement for moving through the development phases) in collaboration with the GPT and GPTD. Program Execution: •Manage cross‑functional alignment and ensure program goals, timelines, KPIs, and milestones are met. •Develop & maintain accurate project plans and forecasts in enterprise planning systems (e.g., PLM). Challenge assumptions and interdependencies to ensure clarity on the true critical path, ensuring plans reflect both strategy and operational realities. •Risk & Issue Management: Identify risks, drive mitigation strategies, and ensure contingencies are in place. •Partner with GPTD to develop Integrated Asset Plans. Communication & Governance: •Manage GPT meeting logistics and prepare high quality GPT agendas and draft minutes in a timely manner. Record action items / decisions and liaise with GPT members on follow-up activities and deliverables. •Facilitate communication, drive alignment, lead program meetings, and ensure operational excellence across R&D, Commercial and TGO •Support timely executive communication of project status as required by the organization (e.g., EM updates, IDC presentations, QBRs, monthly updates, etc) Team & Culture: •Cultivate a high-performing, collaborative team culture grounded in Teva’s leadership principle •Contribute to the evolution of program management best practices and support process improvement initiatives. •Partner with the Global Program Head (GPH) and GPTD to leverage the expertise of team members and drive shared accountability for results leveraging Teva’s GPT operating model Your Skills and Experience •Advanced degree (MSC or MBA) with 8+ years in pharmaceutical industry •Expert project management skills •Strong organisational and communication skills, with the ability to bridge diverse, cross-functional and geographically diverse teams •Advanced knowledge in drug product development Preferred Qualifications: •PMP certification Experience in Project Management •Experience in project management of large scale, complex, international development projects How We’ll Take Care of You At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. Already Working @Teva? Make sure to apply through our internal career site on Twist—your one-stop shop for career development Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to [email protected] with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address. Important notice to Employment Agencies - Please Read Carefully Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
We Are Teva We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. Our Team, Your Impact A Sr. Manager, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents, including submission summaries and other complex documents, provides basic-level oversight and guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations. How You’ll Spend Your Day • Primarily works at a project level. • Writes and edits clinical regulatory documents including study reports, protocols, briefing books, investigator’s brochures, health authority responses, and other submission documents (e.g., module 2.5 and modules 2.7.x). • Compiles, analyzes, and summarizes data from various sources. • Writes and edits clinical regulatory documents including study reports, protocols, briefing books, and other submission documents (e.g. aggregate reports, post authorization safety studies). • Compiles, analyzes, and summarizes data from various sources. • Conducts proofreading, editing, document formatting, and comment resolution. • Ensures documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards. • May participate in the preparation/revision of document templates and SOPs. • May train and support medical writers or external vendors/contractors on document planning, processes, and content development. Your Skills and Experience Education Required: • Bachelor's in life sciences (or other related field). Experience Required: • University degree with a minimum of 8+ years of relevant experience; advanced degree preferred. • Proficient as lead author writing protocols/protocol amendments, clinical study reports, investigator’s brochures, and clinical summary documents (modules 2.5 and 2.7.1-2.7.4) Specialized or Technical Knowledge Licenses, Certifications needed: • Mastery of Microsoft (MS) Word Functional Knowledge: • Solid writing and editing skills of clinical regulatory documents and has competence in using software (e.g., Veeva Vault), templates, and other electronic formats. Has familiarity with industry regulations pertaining to drug development, varied therapeutic areas, statistical concepts, and company products. Company/Industry Related Knowledge: • Knowledge of global regulations and guidelines for document submissions including authoring style guidelines (e.g., AMA). Job-Specific Competencies: • Excellent English, both written and spoken. • Strong interpersonal, critical thinking, and administrative skills with attention to detail. • Demonstrate exceptional written and verbal communication skills to effectively convey complex scientific information to cross-functional teams and regulatory authorities. • Foster a collaborative work environment by actively engaging with key stakeholders to gather necessary information and ensure alignment on project goals and timelines. • Demonstrate flexibility and adaptability to work across diverse teams and manage competing priorities. • Serve as primary point of contact among project teams with ability to lead document development process, including kick off and comment resolution meetings, and drive discussions. • Work to agreed strategy under minimal supervision. • Tackles difficult problems, identify issues, propose solutions, and engage others to resolve issues including escalation to management. • Develop and maintain project timelines, track progress, and deliver assignments with quality and within timelines. • Ensure clarity, accuracy, and compliance in all clinical regulatory documents and submissions. • Contribute to process development and improvement activities. • Provides input for budget and annual operational planning. Also Good to Have Preferred Education: • Master's, MD, PhD, PharmD. Experience Preferred: • 8+ years with an advanced degree. Already Working @Teva? Make sure to apply through our internal career site on Twist—your one-stop shop for career development Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to [email protected] with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address. Important notice to Employment Agencies - Please Read Carefully Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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