Job Description Summary The Precision Medicine Associate Director (PMaD) provides clinical drug development, scientific and technical expertise for successful implementation and execution of the Precision Medicine plans for clinical studies in a given program with a focus on ensuring timely execution to meet studies timelines. Primary Location: London, UK Other Locations: Dublin, Ireland Relocation Support: This role is based in London/Dublin. Novartis is unable to offer relocation support: please only apply if accessible. Job Description Responsibilities: Serves as core member of the BDST and as subject matter expert at the Global Clinical Team (GCT) and/or Clinical trial team (CTT) as applicable. As well as externally e.g. steering committees. Contributes to the Dx target product profile (DxTPP), and the overall IVD/ CDx development strategy and plan. Authors the biomarker/CDx portions of the study protocols and clinical study reports. Avoids strategic and operational crises by proactively identifying and managing potential risks to the program(s) and communicate them timely to GCT/CTT to minimize impact on program. Supports regulatory submissions by acting as biomarker/clinical Dx subject matter expert within the GCT/CTT team. Partners with CBS and other internal stakeholders to ensure all aspects of data collection and analysis are executed with high quality including statistical analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for biomarker study samples. May Support exploratory/scientific external academic collaborations to support biomarker data generation. Ensures Compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Novartis CDx Quality Management System. Essential for the role: Education: MD or Ph.D. OR MD/Ph.D. with minimum of 6 years of experience in the field of precision medicine including CDx/IVD and minimum of 3 years in the pharmaceutical industry. 3+ years multi/cross functional leadership experience within either or Oncology, Immunology, Neuroscience, Cardiometabolic business unit. Excellent knowledge of diagnostics and associated regulatory requirements Expert leadership skills demonstrated in cross functional teams. Expert skills to facilitate/optimise contribution of team members as individuals and member of cohesive team. Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Skills Desired Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk Monitoring
Aug 05, 2025
Full time
Job Description Summary The Precision Medicine Associate Director (PMaD) provides clinical drug development, scientific and technical expertise for successful implementation and execution of the Precision Medicine plans for clinical studies in a given program with a focus on ensuring timely execution to meet studies timelines. Primary Location: London, UK Other Locations: Dublin, Ireland Relocation Support: This role is based in London/Dublin. Novartis is unable to offer relocation support: please only apply if accessible. Job Description Responsibilities: Serves as core member of the BDST and as subject matter expert at the Global Clinical Team (GCT) and/or Clinical trial team (CTT) as applicable. As well as externally e.g. steering committees. Contributes to the Dx target product profile (DxTPP), and the overall IVD/ CDx development strategy and plan. Authors the biomarker/CDx portions of the study protocols and clinical study reports. Avoids strategic and operational crises by proactively identifying and managing potential risks to the program(s) and communicate them timely to GCT/CTT to minimize impact on program. Supports regulatory submissions by acting as biomarker/clinical Dx subject matter expert within the GCT/CTT team. Partners with CBS and other internal stakeholders to ensure all aspects of data collection and analysis are executed with high quality including statistical analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for biomarker study samples. May Support exploratory/scientific external academic collaborations to support biomarker data generation. Ensures Compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Novartis CDx Quality Management System. Essential for the role: Education: MD or Ph.D. OR MD/Ph.D. with minimum of 6 years of experience in the field of precision medicine including CDx/IVD and minimum of 3 years in the pharmaceutical industry. 3+ years multi/cross functional leadership experience within either or Oncology, Immunology, Neuroscience, Cardiometabolic business unit. Excellent knowledge of diagnostics and associated regulatory requirements Expert leadership skills demonstrated in cross functional teams. Expert skills to facilitate/optimise contribution of team members as individuals and member of cohesive team. Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Skills Desired Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk Monitoring
Healthcare Businesswomens Association
Cambridge, Cambridgeshire
Job Description Summary The preferred location for this role is East Hanover, New Jersey, however consideration may be given to Cambridge, Massachusetts. This is an on-site role, at minimum 3 days/week. Job Purpose The US People and Organization (P&O) team is seeking a new People Partner to support the Global Clinical Operations (GCO) organization. Our People Partners act as a trusted advisors offering in-country policy expertise and knowledge to support and educate leaders, managers and associates on all People and Organization (P&O) topics on the moments that matter. People Partners support divisional customer groups in country enabling the delivery of lifecycle events, the employee value proposition, talent acquisition, talent management, learning, performance management, employee relations, rewards, pay and reporting. In addition, People Partners implement P&O change initiatives at a country level acting as agents of change by working collaboratively with Business Partners and Senior People Partners. We work collaboratively across divisions and adapt our support to meet the evolving needs of the business. Job Description Major Accountabilities: • First point of escalation for all leaders and managers on their day-to-day P&O topics, providing expert advice, guidance and support. Accountable for credible P&O People Partnering to leaders, managers and associates, offering advice and guidance on the moments that matter. Coaches and guides people managers on role evaluations in line with local governance. May consult and advise on Team Effectiveness including Psychological Safety. • Implements P&O initiatives, supporting the overall P&O strategy. Ensure People Partnering processes are accomplished with high quality and efficiency. Champions culture and supports implementation of corporate initiatives. • Drive buy-in and utilization of data and analytics to identify risk and trends, and to apply these business insights to inform decisions and actions. • Embraces customer feedback to understand the customer journey with moments that matter and makes recommendations for continuous improvement. Implement enhancements and modification as necessary to meet both the business and customer needs. • Ensure compliance with local equity / Equal Employment Opportunity (EEO) regulations. • Manage the delivery of in-country transformations, consult with legal, provides advice and guidance for managers through the local US process, oversee associate notice / handover meetings and overall restructuring life cycle. • Manage the execution of local implementation of large-scale organizational and day-to-day organizational structure changes, in line with country regulations / policies. • Ensures local Employee Relations regulations are in line with local regulations and Novartis integrity standards from a cross divisional / country lens. Manages Employee relations within client group, coaching and mentoring associates and managers. • Manage internal movement offers and mobility. • Promotes the contribution of ideas and solutions to the P&O network (Country Business Partners, Global Business Partners and Country P&O Boards). Seeks to establish strong relationships with cross-divisional P&O community members to understand needs and challenges and drive continuous improvement. • Support and coach leaders, manager and associates on all P&O topics including promoting self-sufficiency in people processes. Provides coaching and counselling to Country P&O Business Partners on local policies and processes. What you will bring to the role: • BA Degree in a relevant HR or related discipline. • At minimum 5+ years' work experience in P&O - with breadth of experience across P&O disciplines. At minimum 3+ years supporting a complex and metrics organization within the US. A good understanding of global organizations will be an advantage. HR experience supporting a sales organization is preferred. • Strong Interpersonal skills; Proactive, responsive and ability to work independently with all levels of the organization. Ability to handle multiple conflicting tasks and work in an agile way to support a fast-paced environment is a must. Stakeholder Management and ability to collaborate across boundaries. • Coaching and Mentoring; proficient in facilitation, influencing and collaborating across boundaries. Strong Project management capabilities and people analytics skills, effectiveness with data / metrics / reporting to inform decision making. Employee relations, Risk management and Change management expertise. • Fluency in English both oral and written communication skills. • Experience working in a variety of organizations country wide. The salary for this position is expected to range between $ 98,700 to $183,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call + and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $98,700.00 - $183,300.00 Skills Desired Business Acumen, Change Implementation, Coaching, Connecting The Dots, Data Analysis & Reporting, Empathy (Inactive), Employee Lifecycle Management, Employee Relations & Engagement, Influencing, Matrix Collaboration, Operational Excellence, Performance Management, Resilience, Stakeholder Management, Waterfall Model
Jul 25, 2025
Full time
Job Description Summary The preferred location for this role is East Hanover, New Jersey, however consideration may be given to Cambridge, Massachusetts. This is an on-site role, at minimum 3 days/week. Job Purpose The US People and Organization (P&O) team is seeking a new People Partner to support the Global Clinical Operations (GCO) organization. Our People Partners act as a trusted advisors offering in-country policy expertise and knowledge to support and educate leaders, managers and associates on all People and Organization (P&O) topics on the moments that matter. People Partners support divisional customer groups in country enabling the delivery of lifecycle events, the employee value proposition, talent acquisition, talent management, learning, performance management, employee relations, rewards, pay and reporting. In addition, People Partners implement P&O change initiatives at a country level acting as agents of change by working collaboratively with Business Partners and Senior People Partners. We work collaboratively across divisions and adapt our support to meet the evolving needs of the business. Job Description Major Accountabilities: • First point of escalation for all leaders and managers on their day-to-day P&O topics, providing expert advice, guidance and support. Accountable for credible P&O People Partnering to leaders, managers and associates, offering advice and guidance on the moments that matter. Coaches and guides people managers on role evaluations in line with local governance. May consult and advise on Team Effectiveness including Psychological Safety. • Implements P&O initiatives, supporting the overall P&O strategy. Ensure People Partnering processes are accomplished with high quality and efficiency. Champions culture and supports implementation of corporate initiatives. • Drive buy-in and utilization of data and analytics to identify risk and trends, and to apply these business insights to inform decisions and actions. • Embraces customer feedback to understand the customer journey with moments that matter and makes recommendations for continuous improvement. Implement enhancements and modification as necessary to meet both the business and customer needs. • Ensure compliance with local equity / Equal Employment Opportunity (EEO) regulations. • Manage the delivery of in-country transformations, consult with legal, provides advice and guidance for managers through the local US process, oversee associate notice / handover meetings and overall restructuring life cycle. • Manage the execution of local implementation of large-scale organizational and day-to-day organizational structure changes, in line with country regulations / policies. • Ensures local Employee Relations regulations are in line with local regulations and Novartis integrity standards from a cross divisional / country lens. Manages Employee relations within client group, coaching and mentoring associates and managers. • Manage internal movement offers and mobility. • Promotes the contribution of ideas and solutions to the P&O network (Country Business Partners, Global Business Partners and Country P&O Boards). Seeks to establish strong relationships with cross-divisional P&O community members to understand needs and challenges and drive continuous improvement. • Support and coach leaders, manager and associates on all P&O topics including promoting self-sufficiency in people processes. Provides coaching and counselling to Country P&O Business Partners on local policies and processes. What you will bring to the role: • BA Degree in a relevant HR or related discipline. • At minimum 5+ years' work experience in P&O - with breadth of experience across P&O disciplines. At minimum 3+ years supporting a complex and metrics organization within the US. A good understanding of global organizations will be an advantage. HR experience supporting a sales organization is preferred. • Strong Interpersonal skills; Proactive, responsive and ability to work independently with all levels of the organization. Ability to handle multiple conflicting tasks and work in an agile way to support a fast-paced environment is a must. Stakeholder Management and ability to collaborate across boundaries. • Coaching and Mentoring; proficient in facilitation, influencing and collaborating across boundaries. Strong Project management capabilities and people analytics skills, effectiveness with data / metrics / reporting to inform decision making. Employee relations, Risk management and Change management expertise. • Fluency in English both oral and written communication skills. • Experience working in a variety of organizations country wide. The salary for this position is expected to range between $ 98,700 to $183,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call + and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $98,700.00 - $183,300.00 Skills Desired Business Acumen, Change Implementation, Coaching, Connecting The Dots, Data Analysis & Reporting, Empathy (Inactive), Employee Lifecycle Management, Employee Relations & Engagement, Influencing, Matrix Collaboration, Operational Excellence, Performance Management, Resilience, Stakeholder Management, Waterfall Model
Healthcare Businesswomens Association
Cambridge, Cambridgeshire
Job Description Summary The Associate Clinical Development Medical Director (Assoc. CDMD) is responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring, and reporting of quality data. May be responsible for the scientific and medical strategy of assigned sections of a clinical development program, depending on the size and complexity. Job Description MAJOR ACCOUNTABILITIES: Is a global clinical manager or country / cluster leader responsible for clinical program(s) across indications executing medical strategy for development and marketed products in a defined therapeutic area -Responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring. May be responsible for the scientific and medical strategy of assigned sections of a clinical development program. Contributes to the development of clinical sections of trial and program level regulatory documents -Contributes to the execution of the section of the clinical program in partnership with global line functions. Contributes to ensuring overall safety of the compound for assigned trial(s) in collaboration with Patient Safety. Supports by contributing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas -Contributes to medical/scientific training of relevant Novartis stakeholders. May serve as speaker for franchise medical/scientific training -Contributes to the global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) -Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) REQUIREMENTS MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience 4 years (including residency) preferred 3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level Demonstrated ability to establish effective working relationship with key investigators Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes Strong communication skills, written and oral Strong interpersonal skills Strong negotiation and conflict resolution skills Proven ability to work independently or in a cross-functional team setting The salary for this position is expected to range between $204,600 and $379,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call + and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $204,400.00 - $379,600.00 Skills Desired Clinical Trials, Data Analysis, Data Monitoring, Drug Development, Drug Discovery, Medical Strategy, People Management
Jul 23, 2025
Full time
Job Description Summary The Associate Clinical Development Medical Director (Assoc. CDMD) is responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring, and reporting of quality data. May be responsible for the scientific and medical strategy of assigned sections of a clinical development program, depending on the size and complexity. Job Description MAJOR ACCOUNTABILITIES: Is a global clinical manager or country / cluster leader responsible for clinical program(s) across indications executing medical strategy for development and marketed products in a defined therapeutic area -Responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring. May be responsible for the scientific and medical strategy of assigned sections of a clinical development program. Contributes to the development of clinical sections of trial and program level regulatory documents -Contributes to the execution of the section of the clinical program in partnership with global line functions. Contributes to ensuring overall safety of the compound for assigned trial(s) in collaboration with Patient Safety. Supports by contributing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas -Contributes to medical/scientific training of relevant Novartis stakeholders. May serve as speaker for franchise medical/scientific training -Contributes to the global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) -Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) REQUIREMENTS MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience 4 years (including residency) preferred 3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level Demonstrated ability to establish effective working relationship with key investigators Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes Strong communication skills, written and oral Strong interpersonal skills Strong negotiation and conflict resolution skills Proven ability to work independently or in a cross-functional team setting The salary for this position is expected to range between $204,600 and $379,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call + and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $204,400.00 - $379,600.00 Skills Desired Clinical Trials, Data Analysis, Data Monitoring, Drug Development, Drug Discovery, Medical Strategy, People Management
Job Description Summary The Head Protocol & Clinical Program Excellence will provide strategic planning and operational execution support to the Head CD Program Scientific Excellence to deliver on the CD program excellence goals aligned with the overall CD strategy and vision. This role must have keen and broad clinical science insight and experience, to positively impact Novartis' protocols and CDPs, the fundamental units of Development's scientific work. The role will oversee the operational activities of CD Central Integrated Scientific Review Committee (C-ISRC) and work closely with Head CD Program Scientific Excellence, CDHs, GPCHs, as well as cross functional partner functions as needed. This role will provide operational support to leverage latest industry trends, scientific rigor and apply best practices consistently across the CD teams to ensure delivery of high-quality clinical programs. This role is based in the UK / London and in a hybrid working approach. Minimum Requirements: Provides scientific and operational support to the Central Integrated Scientific Review Committee (C-ISRC), ensuring a thorough review of Clinical Development Plans (CDPs) and Key clinical documents (Study protocols, DMC charters, etc), to maintain high levels of quality and consistency across the therapeutic areas. Heads the ISRC Office and is the line function manager for the Director Protocol & Clinical Program Excellence and ISRC Leads in charge of managing ISRC activities. This includes organization of priority topics, key outcomes and actions and regulatory feedback, improvements to C-ISRC strategic advice through establishing and reporting metrics and their review process. Working with Head CD Program Scientific Excellence and CDHs, supports and guides GPCHs for the design, implementation, and execution of clinical development program(s) to support decision milestones, regulatory requirements and market access. Supports and acts as delegate to the Head CD Program Scientific Excellence Head in activities like interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS stakeholders as needed. May serve as senior functional expert for individual clinical projects, e.g. assess results of Phase I-III investigations in preparation for new-drug application. Provides clinical input to evaluate products for in licensing/out licensing, participates in business development processes as needed. Supports in driving scenario development for Clinical Development to support decision analysis and portfolio decisions, as needed. Supports and execute plans on strategic enhancement and simplification of the Novartis clinical development approach (CDP, clinical trial designs, protocol and its review) to improve speed and outcome success of clinical programs. Engages the GPCH and the broader CD community around clinical learnings across therapeutic areas. Supports the CD talent step-up strategy. Supports strategic directions for professional CD capability building. Supports the Head CD Program Scientific Excellence to build cross-function collaborations and initiatives leading to a step-wised transition to the futuristic digital clinical trial era. Key Performance Indicators Seamless delivery of CD program excellence initiatives and projects. Seamless management of regular C-ISRC meeting; documentation of the meeting minutes and follow up of action items. Extensive collaboration and effective partnerships with the relevant stakeholders. Education (minimum/desirable): MD, PhD with extensive clinical development expertise, MD/PhD required. Languages: Fluent oral and written English. Experience/Professional requirement: 10+ years pharmaceutical industry experience; with a focus on medical, clinical development, regulatory and related work. Preferred versatile talents with varied experience beyond clinical. People leadership experience preferred. Broad external connections and strong bonds with KOLs. Outstanding verbal and written communications. Strong evidence of strategic thinking. Strong skills at influencing without formal authority. Proven track record in working across a matrix organization and demonstrating expert skills in building partnerships. Preferred but not required: Oncology clinical development expertise. Skills Desired: Budget Management Clinical Trials Coaching Compliance Cross-Functional Teams Leadership People Management Risk Management Risk Monitoring Strategy
Feb 14, 2025
Full time
Job Description Summary The Head Protocol & Clinical Program Excellence will provide strategic planning and operational execution support to the Head CD Program Scientific Excellence to deliver on the CD program excellence goals aligned with the overall CD strategy and vision. This role must have keen and broad clinical science insight and experience, to positively impact Novartis' protocols and CDPs, the fundamental units of Development's scientific work. The role will oversee the operational activities of CD Central Integrated Scientific Review Committee (C-ISRC) and work closely with Head CD Program Scientific Excellence, CDHs, GPCHs, as well as cross functional partner functions as needed. This role will provide operational support to leverage latest industry trends, scientific rigor and apply best practices consistently across the CD teams to ensure delivery of high-quality clinical programs. This role is based in the UK / London and in a hybrid working approach. Minimum Requirements: Provides scientific and operational support to the Central Integrated Scientific Review Committee (C-ISRC), ensuring a thorough review of Clinical Development Plans (CDPs) and Key clinical documents (Study protocols, DMC charters, etc), to maintain high levels of quality and consistency across the therapeutic areas. Heads the ISRC Office and is the line function manager for the Director Protocol & Clinical Program Excellence and ISRC Leads in charge of managing ISRC activities. This includes organization of priority topics, key outcomes and actions and regulatory feedback, improvements to C-ISRC strategic advice through establishing and reporting metrics and their review process. Working with Head CD Program Scientific Excellence and CDHs, supports and guides GPCHs for the design, implementation, and execution of clinical development program(s) to support decision milestones, regulatory requirements and market access. Supports and acts as delegate to the Head CD Program Scientific Excellence Head in activities like interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS stakeholders as needed. May serve as senior functional expert for individual clinical projects, e.g. assess results of Phase I-III investigations in preparation for new-drug application. Provides clinical input to evaluate products for in licensing/out licensing, participates in business development processes as needed. Supports in driving scenario development for Clinical Development to support decision analysis and portfolio decisions, as needed. Supports and execute plans on strategic enhancement and simplification of the Novartis clinical development approach (CDP, clinical trial designs, protocol and its review) to improve speed and outcome success of clinical programs. Engages the GPCH and the broader CD community around clinical learnings across therapeutic areas. Supports the CD talent step-up strategy. Supports strategic directions for professional CD capability building. Supports the Head CD Program Scientific Excellence to build cross-function collaborations and initiatives leading to a step-wised transition to the futuristic digital clinical trial era. Key Performance Indicators Seamless delivery of CD program excellence initiatives and projects. Seamless management of regular C-ISRC meeting; documentation of the meeting minutes and follow up of action items. Extensive collaboration and effective partnerships with the relevant stakeholders. Education (minimum/desirable): MD, PhD with extensive clinical development expertise, MD/PhD required. Languages: Fluent oral and written English. Experience/Professional requirement: 10+ years pharmaceutical industry experience; with a focus on medical, clinical development, regulatory and related work. Preferred versatile talents with varied experience beyond clinical. People leadership experience preferred. Broad external connections and strong bonds with KOLs. Outstanding verbal and written communications. Strong evidence of strategic thinking. Strong skills at influencing without formal authority. Proven track record in working across a matrix organization and demonstrating expert skills in building partnerships. Preferred but not required: Oncology clinical development expertise. Skills Desired: Budget Management Clinical Trials Coaching Compliance Cross-Functional Teams Leadership People Management Risk Management Risk Monitoring Strategy
Job Description Summary The Precision Medicine Associate Director (PMaD) provides clinical drug development, scientific and technical expertise for successful implementation and execution of the Precision Medicine plans for clinical studies in a given program with a focus on ensuring timely execution to meet studies timelines. Job Description Major accountabilities: Serves as core member of the BDST and as subject matter expert at the Global Clinical Team (GCT) and/or Clinical trial team (CTT) as applicable, as well as externally (e.g., steering committees). Contributes to the Dx target product profile (DxTPP) and the overall IVD/CDx development strategy and plan. Authors the biomarker/CDx portions of the study protocols and clinical study reports. Avoids strategic and operational crises by proactively identifying and managing potential risks to the program(s) and communicate them timely to GCT/CTT to minimize impact on program. Supports regulatory submissions by acting as biomarker/clinical Dx subject matter expert within the GCT/CTT team. Partners with CBS and other internal stakeholders to ensure all aspects of data collection and analysis are executed with high quality, including statistical analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for biomarker study samples. May support exploratory/scientific external academic collaborations to support biomarker data generation. Ensures compliance with applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Novartis CDx Quality Management System. Minimum Requirements: Education: MD or Ph.D. OR MD/Ph.D. with a minimum of 6 years of experience in the field of precision medicine including CDx/IVD and a minimum of 3 years in the pharmaceutical industry. 3+ years of multi/cross-functional leadership experience within either Oncology, Immunology, Neuroscience, or Cardiometabolic business unit. Excellent knowledge of diagnostics and associated regulatory requirements. Expert leadership skills demonstrated in cross-functional teams. Expert skills to facilitate/optimize contribution of team members as individuals and as members of a cohesive team. Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Benefits & Rewards Novartis Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Skills Desired: Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk Monitoring.
Feb 11, 2025
Full time
Job Description Summary The Precision Medicine Associate Director (PMaD) provides clinical drug development, scientific and technical expertise for successful implementation and execution of the Precision Medicine plans for clinical studies in a given program with a focus on ensuring timely execution to meet studies timelines. Job Description Major accountabilities: Serves as core member of the BDST and as subject matter expert at the Global Clinical Team (GCT) and/or Clinical trial team (CTT) as applicable, as well as externally (e.g., steering committees). Contributes to the Dx target product profile (DxTPP) and the overall IVD/CDx development strategy and plan. Authors the biomarker/CDx portions of the study protocols and clinical study reports. Avoids strategic and operational crises by proactively identifying and managing potential risks to the program(s) and communicate them timely to GCT/CTT to minimize impact on program. Supports regulatory submissions by acting as biomarker/clinical Dx subject matter expert within the GCT/CTT team. Partners with CBS and other internal stakeholders to ensure all aspects of data collection and analysis are executed with high quality, including statistical analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for biomarker study samples. May support exploratory/scientific external academic collaborations to support biomarker data generation. Ensures compliance with applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Novartis CDx Quality Management System. Minimum Requirements: Education: MD or Ph.D. OR MD/Ph.D. with a minimum of 6 years of experience in the field of precision medicine including CDx/IVD and a minimum of 3 years in the pharmaceutical industry. 3+ years of multi/cross-functional leadership experience within either Oncology, Immunology, Neuroscience, or Cardiometabolic business unit. Excellent knowledge of diagnostics and associated regulatory requirements. Expert leadership skills demonstrated in cross-functional teams. Expert skills to facilitate/optimize contribution of team members as individuals and as members of a cohesive team. Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Benefits & Rewards Novartis Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Skills Desired: Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk Monitoring.