The job below is no longer available.
You might also like
in Collegeville, PA
$33est. per hour Unisys Corporation • 7h agoUrgently hiring 8.7 mi Use left and right arrow keys to navigate- $72
est. per hour Unisys Corporation • 7h agoUrgently hiring 8.7 mi Use left and right arrow keys to navigate - $17
est. per hour Advantage Solutions • 19h agoUrgently hiring 4.2 mi Use left and right arrow keys to navigate - $17
est. per hour Advantage Solutions • 19h agoUrgently hiring 7.8 mi Use left and right arrow keys to navigate - $56
est. per hour iPipeline • 19h agoUrgently hiring 14.7 mi Use left and right arrow keys to navigate
Category Development Lead, CV Metabolic
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | collegeville, Pennsylvania |
About this job
Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Role Description
The Category Development Lead, Cardiovascular Metabolic Disease (CDL) will provide development and medical expertise to the Category (business strategy and build a portfolio of late-stage clinical candidates through progression of internal programs or business development opportunities).
The CDL directs the execution of category development strategies at the portfolio level to deliver portfolio milestones in a timely, cost-effective, and high quality fashion and are achieved within budget and resource forecast. Responsibilities include global late-stage clinical development programs including design, conduct, and regulatory submission as well as clinical development, post-marketing commitments, and life-cycle studies for all marketed products in the category.
The CDL collaborates with the Category Chief Scientific Officer, (CSO) in the advancement of early-stage clinical candidates, including formation of early-stage clinical development teams, early clinical development program design and objectives, registration objectives, and formation of seamless transition plans that fosters efficient end-to-end development.
The position directs and oversees relationships with key opinion leaders in academia and patient advocacy groups to: (1) foster collaborative research, and (2) gain knowledge of key breakthroughs or discoveries, therapeutic advances, and innovations in clinical practice or in the design, conduct, and outcomes of clinical trials.
The CDL manages a group of up to 50 clinical development colleagues, the majority of whom are MDs and/or hold postgraduate degrees in biomedical sciences (PhD, PharmD, VMD etc). The position is responsible for designing and overseeing trials with an annual budget of $100-300M, in order to develop new medicines with a combined eNPV of >$1B.
Responsibilities
* Provides development and medical expertise to the category (therapeutic area) business strategy
* Builds a portfolio of late-stage clinical candidates through progression of internal programs or business development opportunities
* Monitors and adjusts the late-stage development portfolio balancing strategic and technical risks versus potential commercial value or other business objectives
* Oversees global late-stage clinical development programs including design, conduct, and regulatory submissions
* Oversees additional clinical development, post-marketing commitments, and other life-cycle studies for all marketed products in the category
* Ensures technical review of all late-stage clinical development plans in the category portfolio and that medical and scientific expertise is consistently brought to all clinical program strategy, design, execution, and interpretation activities
* Verifies late-stage clinical development programs are designed to meet global registration and business objectives
* Ensures that global clinical programs in their category are designed and executed to the highest quality standards and in full compliance with all applicable regulatory requirements
* Drives high-quality clinical deliverables including input to and/or leadership of clinical plans, protocols, study reports, and submission documents
* Directs execution of category development strategies at the portfolio level to deliver portfolio milestones in a timely, cost-effective, and high quality fashion and are achieved within budget and resource forecast
* Directs innovative approaches to drug development in category disease areas by external and internal collaboration, interaction with regulators, and continuous improvement in execution of clinical development programs
* Monitors, identifies, and communicates program strategic, technical, or operational risks; ensures development and implementation of risk mitigation plans
* Ensures thorough assessment of emergent safety issues and other risks in clinical programs
* Ensures all category early- and late-stage clinical development teams have appropriate resources and technical expertise to meet strategic objectives
* Collaborates with the category CSO in the advancement of early-stage clinical candidates, including formation of early-stage clinical development teams, early clinical development program design and objectives, registration objectives, and formation of seamless transition plans that fosters efficient end-to-end development
* Secures the latest scientific and regulatory information so that clinical development plans reflect the latest scientific/medical developments and regulatory/commercial environment
* Directs and oversees relationships with key opinion leaders in academia and patient advocacy groups to: (1) foster collaborative research, and (2) gain knowledge of key breakthroughs or discoveries, therapeutic advances, and innovations in clinical practice or in the design, conduct, and outcomes of clinical trials
* Provides direction and oversees interactions with regulatory authorities for all late-stage clinical development programs in the category portfolio
* Directs the clinical assessment and provides key input into relevant business development opportunities evaluated by the category
* Establishes effective peer relationships fostering strong cross-functional collaboration and communication with a broad group of senior internal stakeholders within the category, GMD, and WRD
* Directs the identification, selection, and development of clinical development leaders and staff to continuously improve category therapeutic area knowledge and clinical development experience
* Drives technical excellence and functional competency of colleagues in their category through effective oversight, coaching, mentoring, and training; performance management, and support for continuing professional development as appropriate
* Facilitates team-based behaviors and effectiveness ensuring a learning organization across the category Informs GIP Global Medicines Development Head of category portfolio and program strategic plans, options and recommendations, specific clinical development program strategies, execution, progress and critical issues
* Contributes to GIP Global Medicines Development leadership team
* Guides late-state program teams through category, GIP or Pfizer governance committees
* Maintains personal compliance with training requirements, and fulfills any additional responsibilities as written in SOPs and CTPQS
* Represents GIP on Joint Governance Committees with Business Partners as applicable
Qualifications
EDUCATION AND EXPERIENCE
* MD, PhD or PharmD in relevant life sciences discipline; MD preferred with board certification and license in medical discipline(s) relevant to category
* Minimum of 10 years drug development experience and expertise. Must have in-depth knowledge of relevant therapeutic area(s), drug development, and commercialization processes -- global experience required
* Experience directing multiple late-stage development programs through to registration, post-marketing development experience and early-stage drug development experience highly desired
* Proven track record of clinical trial strategy development and successful execution
* Extensive knowledge of clinical development, global and regional regulations, ICH/GCP
* Record of publications in peer-reviewed journals in disciplines relevant to the category; strong evidence of both clinical and basic science publications preferred
* Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer
* Ability to communicate, develop, and manage collaborative relationships with internal and external key stakeholders
TECHNICAL SKILLS REQUIREMENTS
* Medical/Scientific Excellence - Demonstrated understanding of the complexities and recent developments in the principal disease areas; confident discussing scientific / mechanistic aspects of drug development, also comfortable in discussing commercial and regulatory issues
* Late-Stage Clinical Development Expertise - Demonstrated potential or ability to design, initiate and conduct clinical strategies as part of an integrated clinical plan. Track record of achievement in pharmaceutical development in disease area(s) of relevance; able to independently formulate and execute novel clinical development or lifecycle strategies.
* Clinical Skills - Able to review and understand the emerging safety and efficacy profile of the drug candidates; part of this skill is putting the profile in perspective with clinical practice and regulatory approvals
* Presentation and Analytical Skills - Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data
* Management Experience - Able to set priorities and manage cross-functional teams and multiple or complex projects to deliver milestones according to set budgets; sets priorities; able to define and manage appropriate resource requirements (budgets and FTEs) both in-house and vendors / contractors
* Risk Management -- Able to manage risk and uncertainty with track record of good decision-making based on sound mix of analysis and judgment
* Conflict Management - Able to act as mentor / coach to others to improve conflict management skills; steps up to conflicts, seeing them as opportunities; reads situations quickly; can hammer out tough agreements and settle disputes equitably; provides direct and actionable feedback; prepared to take responsibility for a decision made and support this, even though it may be unpopular
* Recognizing and Developing Talent - Good judge of talent; can articulate strengths and limitations of people; provides challenging tasks and assignments, holds frequent development discussions; is aware of each person's career goals and constructs compelling development plans; is a people builder.
* Networking and Alliance Building - Achieves results through influence in a matrix organization and leverages contributions of colleagues with diverse expertise; builds strong alliances across internal/external stakeholder groups; proactively manages governance
* Change agile - Able to drive, anticipate, influence and manage change, demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change to deliver maximum value for all stakeholders
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Role Description
The Category Development Lead, Cardiovascular Metabolic Disease (CDL) will provide development and medical expertise to the Category (business strategy and build a portfolio of late-stage clinical candidates through progression of internal programs or business development opportunities).
The CDL directs the execution of category development strategies at the portfolio level to deliver portfolio milestones in a timely, cost-effective, and high quality fashion and are achieved within budget and resource forecast. Responsibilities include global late-stage clinical development programs including design, conduct, and regulatory submission as well as clinical development, post-marketing commitments, and life-cycle studies for all marketed products in the category.
The CDL collaborates with the Category Chief Scientific Officer, (CSO) in the advancement of early-stage clinical candidates, including formation of early-stage clinical development teams, early clinical development program design and objectives, registration objectives, and formation of seamless transition plans that fosters efficient end-to-end development.
The position directs and oversees relationships with key opinion leaders in academia and patient advocacy groups to: (1) foster collaborative research, and (2) gain knowledge of key breakthroughs or discoveries, therapeutic advances, and innovations in clinical practice or in the design, conduct, and outcomes of clinical trials.
The CDL manages a group of up to 50 clinical development colleagues, the majority of whom are MDs and/or hold postgraduate degrees in biomedical sciences (PhD, PharmD, VMD etc). The position is responsible for designing and overseeing trials with an annual budget of $100-300M, in order to develop new medicines with a combined eNPV of >$1B.
Responsibilities
* Provides development and medical expertise to the category (therapeutic area) business strategy
* Builds a portfolio of late-stage clinical candidates through progression of internal programs or business development opportunities
* Monitors and adjusts the late-stage development portfolio balancing strategic and technical risks versus potential commercial value or other business objectives
* Oversees global late-stage clinical development programs including design, conduct, and regulatory submissions
* Oversees additional clinical development, post-marketing commitments, and other life-cycle studies for all marketed products in the category
* Ensures technical review of all late-stage clinical development plans in the category portfolio and that medical and scientific expertise is consistently brought to all clinical program strategy, design, execution, and interpretation activities
* Verifies late-stage clinical development programs are designed to meet global registration and business objectives
* Ensures that global clinical programs in their category are designed and executed to the highest quality standards and in full compliance with all applicable regulatory requirements
* Drives high-quality clinical deliverables including input to and/or leadership of clinical plans, protocols, study reports, and submission documents
* Directs execution of category development strategies at the portfolio level to deliver portfolio milestones in a timely, cost-effective, and high quality fashion and are achieved within budget and resource forecast
* Directs innovative approaches to drug development in category disease areas by external and internal collaboration, interaction with regulators, and continuous improvement in execution of clinical development programs
* Monitors, identifies, and communicates program strategic, technical, or operational risks; ensures development and implementation of risk mitigation plans
* Ensures thorough assessment of emergent safety issues and other risks in clinical programs
* Ensures all category early- and late-stage clinical development teams have appropriate resources and technical expertise to meet strategic objectives
* Collaborates with the category CSO in the advancement of early-stage clinical candidates, including formation of early-stage clinical development teams, early clinical development program design and objectives, registration objectives, and formation of seamless transition plans that fosters efficient end-to-end development
* Secures the latest scientific and regulatory information so that clinical development plans reflect the latest scientific/medical developments and regulatory/commercial environment
* Directs and oversees relationships with key opinion leaders in academia and patient advocacy groups to: (1) foster collaborative research, and (2) gain knowledge of key breakthroughs or discoveries, therapeutic advances, and innovations in clinical practice or in the design, conduct, and outcomes of clinical trials
* Provides direction and oversees interactions with regulatory authorities for all late-stage clinical development programs in the category portfolio
* Directs the clinical assessment and provides key input into relevant business development opportunities evaluated by the category
* Establishes effective peer relationships fostering strong cross-functional collaboration and communication with a broad group of senior internal stakeholders within the category, GMD, and WRD
* Directs the identification, selection, and development of clinical development leaders and staff to continuously improve category therapeutic area knowledge and clinical development experience
* Drives technical excellence and functional competency of colleagues in their category through effective oversight, coaching, mentoring, and training; performance management, and support for continuing professional development as appropriate
* Facilitates team-based behaviors and effectiveness ensuring a learning organization across the category Informs GIP Global Medicines Development Head of category portfolio and program strategic plans, options and recommendations, specific clinical development program strategies, execution, progress and critical issues
* Contributes to GIP Global Medicines Development leadership team
* Guides late-state program teams through category, GIP or Pfizer governance committees
* Maintains personal compliance with training requirements, and fulfills any additional responsibilities as written in SOPs and CTPQS
* Represents GIP on Joint Governance Committees with Business Partners as applicable
Qualifications
EDUCATION AND EXPERIENCE
* MD, PhD or PharmD in relevant life sciences discipline; MD preferred with board certification and license in medical discipline(s) relevant to category
* Minimum of 10 years drug development experience and expertise. Must have in-depth knowledge of relevant therapeutic area(s), drug development, and commercialization processes -- global experience required
* Experience directing multiple late-stage development programs through to registration, post-marketing development experience and early-stage drug development experience highly desired
* Proven track record of clinical trial strategy development and successful execution
* Extensive knowledge of clinical development, global and regional regulations, ICH/GCP
* Record of publications in peer-reviewed journals in disciplines relevant to the category; strong evidence of both clinical and basic science publications preferred
* Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer
* Ability to communicate, develop, and manage collaborative relationships with internal and external key stakeholders
TECHNICAL SKILLS REQUIREMENTS
* Medical/Scientific Excellence - Demonstrated understanding of the complexities and recent developments in the principal disease areas; confident discussing scientific / mechanistic aspects of drug development, also comfortable in discussing commercial and regulatory issues
* Late-Stage Clinical Development Expertise - Demonstrated potential or ability to design, initiate and conduct clinical strategies as part of an integrated clinical plan. Track record of achievement in pharmaceutical development in disease area(s) of relevance; able to independently formulate and execute novel clinical development or lifecycle strategies.
* Clinical Skills - Able to review and understand the emerging safety and efficacy profile of the drug candidates; part of this skill is putting the profile in perspective with clinical practice and regulatory approvals
* Presentation and Analytical Skills - Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data
* Management Experience - Able to set priorities and manage cross-functional teams and multiple or complex projects to deliver milestones according to set budgets; sets priorities; able to define and manage appropriate resource requirements (budgets and FTEs) both in-house and vendors / contractors
* Risk Management -- Able to manage risk and uncertainty with track record of good decision-making based on sound mix of analysis and judgment
* Conflict Management - Able to act as mentor / coach to others to improve conflict management skills; steps up to conflicts, seeing them as opportunities; reads situations quickly; can hammer out tough agreements and settle disputes equitably; provides direct and actionable feedback; prepared to take responsibility for a decision made and support this, even though it may be unpopular
* Recognizing and Developing Talent - Good judge of talent; can articulate strengths and limitations of people; provides challenging tasks and assignments, holds frequent development discussions; is aware of each person's career goals and constructs compelling development plans; is a people builder.
* Networking and Alliance Building - Achieves results through influence in a matrix organization and leverages contributions of colleagues with diverse expertise; builds strong alliances across internal/external stakeholder groups; proactively manages governance
* Change agile - Able to drive, anticipate, influence and manage change, demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change to deliver maximum value for all stakeholders
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.