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Posted : Monday, October 16, 2023 08:57 AM
Overview:
If you are a Jazz employee please apply via the Internal Career site
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families.
We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.
We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology.
We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies.
Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries.
For more information, please visit www.
jazzpharmaceuticals.
com and follow @JazzPharma on Twitter.
Position Profile: Brief Description: The Clinical Development Lead, for Zanidatamab, BTC (Biliary Tract Cancer) and GEA (Gastroesophageal Adenocarcinoma) will lead the late-stage development and life-cycle management of Zanidatamab for BTC and GEA.
The Clinical Development Lead will play a pivotal role in driving the Clinical Development strategy for BTC and GEA, including new-related indications, working with a cross functional matrix team to advance the development of Zanidatamab throughout the development life cycle through to commercialization.
The Clinical Development Lead will also be responsible for leading a team of Medical Directors and Clinical Scientists.
Responsibilities include resource planning and allocation, budget management and development of the team to instill a high-performance culture driving the team to focus on positive outcomes for the patients we serve.
Essential Functions/Responsibilities Strategic Leadership: Provide strategic direction and leadership for the clinical development of BTC and GEA Zanidatamab program, aligning with overall corporate goals and objectives.
Clinical Development Planning: Develop and execute comprehensive Global clinical development plans for Zanidatamab in the context of BTC and GEA, including study design, protocol development, and regulatory strategy for all geographies.
Cross-functional Collaboration: Collaborate closely with cross-functional teams, including clinical pharmacology, translational medicine, clinical operations, medical affairs, regulatory affairs, and commercial, to ensure seamless execution of clinical development programs.
Regulatory Compliance: Ensure compliance with regulatory requirements and guidelines, working closely with regulatory affairs to facilitate timely submissions and approvals.
Clinical Trial Oversight: Oversee the execution of clinical trials, monitoring study progress, data quality, and patient safety throughout all phases of development.
Data Analysis and Interpretation: Analyze clinical trial data and collaborate with biostatisticians and clinical scientists to interpret results, draw conclusions, and make informed decisions regarding trial progression.
Risk Management: Proactively identify risks and issues related to clinical development programs and develop mitigation strategies to ensure successful outcomes.
External Collaboration: Cultivate and maintain relationships with key opinion leaders, academic institutions, clinical investigators, and collaborative partners to enhance scientific exchange and advance the oncology pipeline.
Budget and Resource Management: Manage budget allocation and resource planning for clinical development programs, optimizing efficiency and maximizing return on investment.
People Development: Foster a high-performance culture based on excellence, innovation, and accountability within the BTC and GEA clinical development team, providing mentorship and professional development opportunities to team members.
Required Knowledge, Skills, and Abilities Demonstrable experience with leading the development of a Solid Tumor Oncology asset successfully through late-stage development resulting in approval and commercialization.
Proven experience with leading and developing high performing clinical development teams.
Executive presence consistent with the level of the role, able to confidently and concisely articulate complex insights and data to executive level audiences both internally and externally.
Required/Preferred Education and Licenses MD required.
Board certified Oncologist preferred.
Higher postgraduate degree e.
g.
, PhD preferred.
Clinical and/or development experience in solid tumor oncology, such as BTC or Gastrointestinal cancers is preferred.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US-BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc.
is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.
For this role, the full and complete base pay range is $0-$0.
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors.
The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy.
Internal equity considerations will also influence individual base pay decisions.
This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package.
The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.
For more information on our Benefits offerings please click here: https://careers.
jazzpharma.
com/benefits
We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.
We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology.
We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies.
Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries.
For more information, please visit www.
jazzpharmaceuticals.
com and follow @JazzPharma on Twitter.
Position Profile: Brief Description: The Clinical Development Lead, for Zanidatamab, BTC (Biliary Tract Cancer) and GEA (Gastroesophageal Adenocarcinoma) will lead the late-stage development and life-cycle management of Zanidatamab for BTC and GEA.
The Clinical Development Lead will play a pivotal role in driving the Clinical Development strategy for BTC and GEA, including new-related indications, working with a cross functional matrix team to advance the development of Zanidatamab throughout the development life cycle through to commercialization.
The Clinical Development Lead will also be responsible for leading a team of Medical Directors and Clinical Scientists.
Responsibilities include resource planning and allocation, budget management and development of the team to instill a high-performance culture driving the team to focus on positive outcomes for the patients we serve.
Essential Functions/Responsibilities Strategic Leadership: Provide strategic direction and leadership for the clinical development of BTC and GEA Zanidatamab program, aligning with overall corporate goals and objectives.
Clinical Development Planning: Develop and execute comprehensive Global clinical development plans for Zanidatamab in the context of BTC and GEA, including study design, protocol development, and regulatory strategy for all geographies.
Cross-functional Collaboration: Collaborate closely with cross-functional teams, including clinical pharmacology, translational medicine, clinical operations, medical affairs, regulatory affairs, and commercial, to ensure seamless execution of clinical development programs.
Regulatory Compliance: Ensure compliance with regulatory requirements and guidelines, working closely with regulatory affairs to facilitate timely submissions and approvals.
Clinical Trial Oversight: Oversee the execution of clinical trials, monitoring study progress, data quality, and patient safety throughout all phases of development.
Data Analysis and Interpretation: Analyze clinical trial data and collaborate with biostatisticians and clinical scientists to interpret results, draw conclusions, and make informed decisions regarding trial progression.
Risk Management: Proactively identify risks and issues related to clinical development programs and develop mitigation strategies to ensure successful outcomes.
External Collaboration: Cultivate and maintain relationships with key opinion leaders, academic institutions, clinical investigators, and collaborative partners to enhance scientific exchange and advance the oncology pipeline.
Budget and Resource Management: Manage budget allocation and resource planning for clinical development programs, optimizing efficiency and maximizing return on investment.
People Development: Foster a high-performance culture based on excellence, innovation, and accountability within the BTC and GEA clinical development team, providing mentorship and professional development opportunities to team members.
Required Knowledge, Skills, and Abilities Demonstrable experience with leading the development of a Solid Tumor Oncology asset successfully through late-stage development resulting in approval and commercialization.
Proven experience with leading and developing high performing clinical development teams.
Executive presence consistent with the level of the role, able to confidently and concisely articulate complex insights and data to executive level audiences both internally and externally.
Required/Preferred Education and Licenses MD required.
Board certified Oncologist preferred.
Higher postgraduate degree e.
g.
, PhD preferred.
Clinical and/or development experience in solid tumor oncology, such as BTC or Gastrointestinal cancers is preferred.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US-BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc.
is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.
For this role, the full and complete base pay range is $0-$0.
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors.
The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy.
Internal equity considerations will also influence individual base pay decisions.
This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package.
The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.
For more information on our Benefits offerings please click here: https://careers.
jazzpharma.
com/benefits
• Phone : NA
• Location : Remote Office Non Sales, Palo Alto, CA
• Post ID: 9136632101
