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Clinical Scientist (m/f/d) – Drug Development
Aussicht: 181
Update Tag: 24-10-2024
Ort: Hallbergmoos Bavaria
Kategorie: R & D IT - Software
Industrie: Biotechnology
Position: Associate
Jobtyp: Full-time
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Jobinhalt
Read Job Description InIhre Aufgaben- You will contribute to and may co-lead alongside the Medical Director the scientific/clinical activities on the assigned clinical study/ies and/or project(s)
- You will work closely with the Medical Director on program strategy and execution
- You will interact with a multi-disciplinary global team in a matrix structure, ensuring that clinical and scientific topics are appropriately addressed
- You will have a significant impact on the generation, conduct, and execution of clinical studies within the assigned program(s)
- You will perform clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle
- You will be responsible for the quality of reviews/ insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review
- You will contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. You will also contribute to the review and writing of clinical trial documents for study CSR activities, and publications (if applicable)
- Graduate in Life Sciences (e.g. Bachelor/Master of Sciences, Bachelor/Master in Nursing, Pharm.D., MPharm, PhD, MBBS, BDS, MD)
- Experience in clinical development, preferably in the pharmaceutical industry/CRO
- Expertise in Oncology, Immunology or Respiratory research or clinical development highly desirable
- Ability to work independently on assigned tasks or projects of increasing complexity with scientific rigor
- Aptitude to interpret and to integrate data, including, clinical safety and efficacy data, pharmacokinetics, biomarker and next generation sequencing data
- Ability to work in a global matrix organization environment, across different geographies, time-zones, ability to adapt to different working practices and styles based on diverse cultural backgrounds.
- Proficient in English. Knowledge of additional languages will be an asset
Wir sind ein stark wachsendes Biotechnologie-Unternehmen mit ca. 130 Mitarbeitern an den Standorten Hallbergmoos (Großraum München) und Boston (USA). Wir arbeiten in flachen Hierarchien mit kurzen Entscheidungswegen und bieten ein Arbeitsumfeld, welches sich durch Zusammenarbeit und Innovation auszeichnet.
Zahlreiche Sozialleistungen wie eine zusätzliche arbeitgeberfinanzierte betriebliche Krankenversicherung, freie Getränke, Obstkörbe etc. sowie eine helle, freundliche und hochmoderne Arbeitsumgebung mit hervorragender technischer Ausstattung in unserem neuen Firmengebäude in Hallbergmoos runden unser Gesamtpaket ab. Mehrmals jährlich finden kreative Mitarbeiterveranstaltungen statt, da Zusammenhalt bei uns großgeschrieben wird. Die gemeinsame Gestaltung einer innovativen und partizipativen Unternehmenskultur ist uns ein wichtiges Anliegen.
EEO Statement
Pieris Pharmaceuticals stands firmly against racial discrimination and social injustice. At our company, everyone has a voice and we are committed to equality, inclusiveness, respect and kindness. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, disability status, age, marital status, protected veteran status, or other characteristic protected by law. Pieris Pharmaceuticals is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please send an email to: Recruiting@Pieris.com
Wie Sie uns erreichen
Hallbergmoos (Germany)
Zeppelinstraße 3
85399 Hallbergmoos
+49 (0) 811 - 12447 0
Boston (USA)
Pieris Pharmaceuticals, Inc.
255 State Street, 9th floor
Boston, MA 02109
+1 (857) 246-8998
Thomas Schwarzbauer
Talent Acquisition Manager
+49 174 214 0851
Jetzt bewerben
Über uns
Pieris Pharmaceuticals (Nasdaq: PIRS) ist ein in der klinischen Phase befindliches Biotechnologieunternehmen mit Standorten in Deutschland und den USA. Pieris erforscht und entwickelt Anticalin® basierte Medikamente und adressiert validierte krankheitsrelevante Signalwege in einer einzigartigen und transformativen Weise. Unsere Pipeline umfasst inhalationsfähige Anticalin-Proteine zur Behandlung von Atemwegserkrankungen sowie immun-onkologische Multispezifika, die auf die Mikroumgebung des Tumors zugeschnitten sind. Bei den Anticalin-Proteinen handelt es sich um eine neue Klasse von Therapeutika, die in der Klinik und durch Partnerschaften mit führenden Pharmaunternehmen entwickelt wurden. Wir haben es uns zur Aufgabe gemacht, durch die innovative Kombination von Wissenschaft und Spitzentechnologien, lebensverändernde therapeutische Proteine für Patienten zu entwickeln, die an Krebs und Atemwegserkrankungen leiden.
Your Tasks
- You will contribute to and may co-lead alongside the Medical Director the scientific/clinical activities on the assigned clinical study/ies and/or project(s)
- You will work closely with the Medical Director on program strategy and execution
- You will interact with a multi-disciplinary global team in a matrix structure, ensuring that clinical and scientific topics are appropriately addressed
- You will have a significant impact on the generation, conduct, and execution of clinical studies within the assigned program(s)
- You will perform clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle
- You will be responsible for the quality of reviews/ insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review
- You will contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. You will also contribute to the review and writing of clinical trial documents for study CSR activities, and publications (if applicable)
- Graduate in Life Sciences (e.g. Bachelor/Master of Sciences, Bachelor/Master in Nursing, Pharm.D., MPharm, PhD, MBBS, BDS, MD)
- Experience in clinical development, preferably in the pharmaceutical industry/CRO
- Expertise in Oncology, Immunology or Respiratory research or clinical development highly desirable
- Ability to work independently on assigned tasks or projects of increasing complexity with scientific rigor
- Aptitude to interpret and to integrate data, including, clinical safety and efficacy data, pharmacokinetics, biomarker and next generation sequencing data
- Ability to work in a global matrix organization environment, across different geographies, time-zones, ability to adapt to different working practices and styles based on diverse cultural backgrounds.
- Proficient in English. Knowledge of additional languages will be an asset
Pieris is a fast-growing biotechnology company with approximately 130 employees across our sites in Munich, Germany and Boston, United States. We work in flat hierarchies with short decision-making paths and offer a working environment characterized by cooperation and innovation. Each of our employees participates in a bonus program based on the achievement of our company goals. In addition, we offer each employee the opportunity to participate in a stock purchase plan as well as a stock option program that allows Pieris employees to benefit directly from the our success.
Numerous social benefits such as an additional employer-financed company health insurance, free drinks etc. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment in both of our locations round off our overall package. Creative employee events take place several times a year, as we believe that a healthy spirit of collaboration is key to our success.
EEO Statement
Pieris Pharmaceuticals stands firmly against racial discrimination and social injustice. At our company, everyone has a voice and we are committed to equality, inclusiveness, respect and kindness. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, disability status, age, marital status, protected veteran status, or other characteristic protected by law. Pieris Pharmaceuticals is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please send an email to: Recruiting@Pieris.com
How To Reach Us
Hallbergmoos (Germany)
Zeppelinstraße 3
85399 Hallbergmoos
+49 (0) 811 - 12447 0
Boston (USA)
Pieris Pharmaceuticals, Inc.
255 State Street, 9th floor
Boston, MA 02109
+1 (857) 246-8998
Thomas Schwarzbauer
Talent Acquisition Manager
+49 174 214 0851
Apply for this position
About Us
Pieris Pharmaceuticals (Nasdaq: PIRS) is a clinical-stage biotechnology company with operations in Germany and the United States. Pieris discovers and develops Anticalin protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases and immuno-oncology multi-specifics tailored for the tumor microenvironment. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. It is our mission to develop life-changing therapeutic proteins for patients suffering from cancer and respiratory diseases through the innovative application of novel science and cutting-edge technologies.
Numerous social benefits such as an additional employer-financed company health insurance, free drinks etc. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment in both of our locations round off our overall package. Creative employee events take place several times a year, as we believe that a healthy spirit of collaboration is key to our success.
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Frist: 08-12-2024
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