Leader in Immunology Pieris Pharmaceuticals GmbH

Pieris Pharmaceuticals GmbH is a subsidiary of Pieris Pharmaceuticals Inc., a publicly traded, clinical-stage biotech company (Nasdaq:PIRS). We are advancing our proprietary next generation therapeutic proteins, Anticalins®, in a variety of therapeutic areas to create differentiated drugs that are safer and more effective than conventional approaches. Exclusive to Pieris, Anticalin proteins promise to address high-unmet medical needs and expand the potential of targeted therapeutics. Do you have what it takes? Position: Immuno-oncology (IO) Therapeutic Program Leader, Ref.-165 Location: Freising, Germany In connection with having direct responsibility for coordinating the IND-enabling activities and subsequent clinical development for a proprietary IO bispecific drug program, the IO Therapeutic Program Leader position will encompass key roles and responsibilities that include: Overall leadership to advance a defined preclinical stage program into clinical development, championing the project vision throughout, drawing on a project team internal and external personnel Generating plans, proposals, timelines, and budgets to allow clear direction of the project and enable alignment of resources Leading the project team to develop an integrated cross-functional project implementation plan (including CMC, regulatory strategies and clinical protocol design), coordinating these development activities to achieve the project goals Ensuring that all project team members understand project goals and objectives, up-to-date project plan and schedule, critical path activities and activities that may become critical path activities Collaborating effectively with CMOs, CROs, regulatory agencies, key opinion leaders, clinicians, and external companies as appropriate Monitoring project progress, costs, resource allocations, timelines and develop corrective actions if deviations occur Making data-driven decisions, reporting the project progress to senior management and defending the project through review processes (timelines, resource requirements, Target Product Profile) Writing reports for diverse audiences to engage and educate others in the project vision, objectives and achievements Qualifications and experience: For this challenging position we are seeking a highly motivated individual with a PhD, MD, or relevant advanced degree with an immunology and oncology focus and relevant experience in preclinical and clinical development. Preferred candidates should possess relevant experience and a thorough understanding of all aspects of biologics drug development i.e. research, preclinical, CMC, regulatory affairs and clinical In-depth knowledge of oncology, inflammation and/or immunology development and disease areas; preferably, experience in preclinical and clinical development of cancer immunotherapies Proven track record of experience moving biologics (including antibody and/or protein therapeutics) into clinical development stages. Experience with clinical and translational investigation of cancer immunotherapies is a plus Strong experience in project leadership obtained through participation in cross-functional and matrix teams with a proven track record of success; experience directly managing project managers and project teams interacting effectively across boundaries with other functions and disciplines using influencing, communication and relationship building skills Proven ability to strategize, prioritize, and manage projects to ensure quality, timely, on-target and within budget accomplishment of tasks as well as determine what resources and talents are needed for the rapid progression of the projects Ability to discriminate between critical and non-critical activities and to follow established processes while identifying areas for process improvement Evidence of good clinical and scientific judgment. Ability to interpret the significance of preclinical and clinical data, and to anticipate the information that will be needed to satisfy regulatory requirements for early and late phase oncology studies Attention to detail with excellent communication (both written and verbal), presentation and organizational skills including demonstrated ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders High degree of interpersonal skills with an ability to work effectively with partners and multiple stakeholders Ability to effectively manage conflicts and negotiations while providing impact and influence Experience working collaboratively with key external oncology experts on a global scale Vision and strategy: a passion to develop novel therapeutics for cancer patients. A deep understanding of areas of unmet clinical need and the ability to integrate this with the drug development activities required to advance compounds to POC and registration trials Fluency in written and spoken English. German language skills preferred but not required We offer: Growing biotech company with excellent perspectives Small, dynamic team with a worldwide reach Working in an exciting scientific environment If you are interested to work in an exciting environment, please send your resume and cover letter in English to Pieris Pharmaceuticals’ HR department at hr.de@pieris.com. See www.pieris.com for further Information. If you apply for this position please say you saw it on Medicinoxy

Pieris Pharmaceuticals GmbH is a subsidiary of Pieris Pharmaceuticals Inc., a publicly traded, clinical-stage biotech company (Nasdaq:PIRS). We are advancing our proprietary next generation therapeutic proteins, Anticalins®, in a variety of therapeutic areas to create differentiated drugs that are safer and more effective than conventional approaches. Exclusive to Pieris, Anticalin proteins promise to address high-unmet medical needs and expand the potential of targeted therapeutics.

Do you have what it takes?

Position: Immuno-oncology (IO) Therapeutic Program Leader, Ref.-165
Location: Freising, Germany

In connection with having direct responsibility for coordinating the IND-enabling activities and subsequent clinical development for a proprietary IO bispecific drug program, the IO Therapeutic Program Leader position will encompass key roles and responsibilities that include:

Overall leadership to advance a defined preclinical stage program into clinical development, championing the project vision throughout, drawing on a project team internal and external personnel
Generating plans, proposals, timelines, and budgets to allow clear direction of the project and enable alignment of resources
Leading the project team to develop an integrated cross-functional project implementation plan (including CMC, regulatory strategies and clinical protocol design), coordinating these development activities to achieve the project goals
Ensuring that all project team members understand project goals and objectives, up-to-date project plan and schedule, critical path activities and activities that may become critical path activities
Collaborating effectively with CMOs, CROs, regulatory agencies, key opinion leaders, clinicians, and external companies as appropriate
Monitoring project progress, costs, resource allocations, timelines and develop corrective actions if deviations occur
Making data-driven decisions, reporting the project progress to senior management and defending the project through review processes (timelines, resource requirements, Target Product Profile)
Writing reports for diverse audiences to engage and educate others in the project vision, objectives and achievements

Qualifications and experience:

For this challenging position we are seeking a highly motivated individual with a PhD, MD, or relevant advanced degree with an immunology and oncology focus and relevant experience in preclinical and clinical development.

Preferred candidates should possess relevant experience and a thorough understanding of all aspects of biologics drug development i.e. research, preclinical, CMC, regulatory affairs and clinical
In-depth knowledge of oncology, inflammation and/or immunology development and disease areas; preferably, experience in preclinical and clinical development of cancer immunotherapies
Proven track record of experience moving biologics (including antibody and/or protein therapeutics) into clinical development stages. Experience with clinical and translational investigation of cancer immunotherapies is a plus
Strong experience in project leadership obtained through participation in cross-functional and matrix teams with a proven track record of success; experience directly managing project managers and project teams interacting effectively across boundaries with other functions and disciplines using influencing, communication and relationship building skills
Proven ability to strategize, prioritize, and manage projects to ensure quality, timely, on-target and within budget accomplishment of tasks as well as determine what resources and talents are needed for the rapid progression of the projects
Ability to discriminate between critical and non-critical activities and to follow established processes while identifying areas for process improvement
Evidence of good clinical and scientific judgment. Ability to interpret the significance of preclinical and clinical data, and to anticipate the information that will be needed to satisfy regulatory requirements for early and late phase oncology studies
Attention to detail with excellent communication (both written and verbal), presentation and organizational skills including demonstrated ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders
High degree of interpersonal skills with an ability to work effectively with partners and multiple stakeholders
Ability to effectively manage conflicts and negotiations while providing impact and influence
Experience working collaboratively with key external oncology experts on a global scale
Vision and strategy: a passion to develop novel therapeutics for cancer patients. A deep understanding of areas of unmet clinical need and the ability to integrate this with the drug development activities required to advance compounds to POC and registration trials
Fluency in written and spoken English. German language skills preferred but not required

We offer:

Growing biotech company with excellent perspectives
Small, dynamic team with a worldwide reach
Working in an exciting scientific environment

If you are interested to work in an exciting environment, please send your resume and cover letter in English to Pieris Pharmaceuticals’ HR department at hr.de@pieris.com. See www.pieris.com for further Information.

If you apply for this position please say you saw it on Medicinoxy