Global Principal Expert Clinical Strategy (m/f/d) - Clinical R&D
Vienna, Austria · On-site
Senior+
Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from h…
Skills: Clinical Strategy, Clinical Development Planning, Protocol Development, Clinical Study Design, Regulatory Interactions
Global Principal Expert Clinical Strategy (m/f/d) - Clinical R&D
Vienna, Austria · On-site
Senior+
Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from h…
Skills: Clinical Strategy, Clinical Development Planning, Protocol Development, Clinical Study Design, Regulatory Interactions
Rejoignez une chaîne vitale et contribuez à notre objectif commun : améliorer la santé et la vie de nos patients et patientes. Octapharma est l'un des plus grands exploitants de protéines humaines au monde. Nous développ…
Rejoignez une chaîne vitale et contribuez à notre objectif commun : améliorer la santé et la vie de nos patients et patientes. Octapharma est l'un des plus grands exploitants de protéines humaines au monde. Nous développ…
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Rejoignez une chaîne vitale et contribuez à notre objectif commun : améliorer la santé et la vie de nos patients et patientes. Octapharma est l'un des plus grands exploitants de protéines humaines au monde. Nous développ…
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Bli en del av en livsviktig kedja och bidra till vårt gemensamma mål att förbättra människors liv. Octapharma är ett ledande biotekniskt läkemedelsföretag som kombinerar styrkan hos en global organisation med värderingar…
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Werden Sie Teil einer lebenswichtigen Kette und tragen Sie zu unserem gemeinsamen Ziel bei, das Leben von Menschen zu verbessern. Octapharma ist einer der weltweit größten Hersteller von Arzneimitteln auf Basis von Human…
Bli en del av en livsviktig kedja och bidra till vårt gemensamma mål att förbättra människors liv. Octapharma är ett ledande biotekniskt läkemedelsföretag som kombinerar styrkan hos en global organisation med värderingar…
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Rejoignez une chaîne vitale et contribuez à notre objectif commun : améliorer la santé et la vie de nos patients et patientes. Octapharma est l'un des plus grands exploitants de protéines humaines au monde. Nous développ…
Bli en del av en livsviktig kedja och bidra till vårt gemensamma mål att förbättra människors liv. Octapharma är ett ledande biotekniskt läkemedelsföretag som kombinerar styrkan hos en global organisation med värderingar…
Werden Sie Teil einer lebenswichtigen Kette und tragen Sie zu unserem gemeinsamen Ziel bei, das Leben von Menschen zu verbessern. Octapharma ist einer der weltweit größten Hersteller von Arzneimitteln auf Basis von Human…
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Werden Sie Teil einer lebenswichtigen Kette und tragen Sie zu unserem gemeinsamen Ziel bei, das Leben von Menschen zu verbessern. Octapharma ist einer der weltweit größten Hersteller von Arzneimitteln auf Basis von Human…
Werden Sie Teil einer lebenswichtigen Kette und tragen Sie zu unserem gemeinsamen Ziel bei, das Leben von Menschen zu verbessern. Octapharma ist einer der weltweit größten Hersteller von Arzneimitteln auf Basis von Human…
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Werden Sie Teil einer lebenswichtigen Kette und tragen Sie zu unserem gemeinsamen Ziel bei, das Leben von Menschen zu verbessern. Octapharma ist einer der weltweit größten Hersteller von Arzneimitteln auf Basis von Human…
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Werden Sie Teil einer lebenswichtigen Kette und tragen Sie zu unserem gemeinsamen Ziel bei, das Leben von Menschen zu verbessern. Octapharma ist einer der weltweit größten Hersteller von Arzneimitteln auf Basis von Human…
Werden Sie Teil einer lebenswichtigen Kette und tragen Sie zu unserem gemeinsamen Ziel bei, das Leben von Menschen zu verbessern. Octapharma ist einer der weltweit größten Hersteller von Arzneimitteln auf Basis von Human…
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Full-time
postgraduate degree
Company Restaurant, Meal Subsidy, Training And Further Education, Health Promotion, Parking Spaces, Public Transport Connections
Posted 6d ago
~38 hrs/week
Responsibilities
Lead the development of global clinical strategies and patient-centric development plans across all phases of clinical research. Collaborate with cross-functional teams and external experts to drive innovative trial designs and ensure successful program execution.
Requirements
Requires a degree in Medicine, Pharmacy, or Life Sciences (MD, PharmD, or PhD preferred) with at least 10 years of experience in pharmaceutical or CRO clinical development. Must possess strong expertise in protocol development, regulatory submissions, and strategic stakeholder management.
Full job description
Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.
With over 1700 employees, the Octapharma site in Vienna is the largest production site, and successful research and development location.
Your main tasks and responsibilities
Lead the development of global clinical strategies across all phases of clinical development
Develop integrated, patient-centric clinical development plans aligned with scientific, regulatory and business objectives
Provide strategic oversight for study concepts, clinical protocols and key development deliverables
Drive innovative clinical development approaches, including novel trial designs and real-world evidence generation
Partner with Regulatory Affairs to support global regulatory strategies and health authority interactions
Collaborate across Clinical Development, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs and Business Unit functions to ensure successful program execution
Build strong relationships with external experts, investigators, key opinion leaders and regulatory authorities
Your expertise and ideal skill set
Completed degree in Medicine, Pharmacy, Life Sciences or another relevant scientific discipline (MD, PharmD or PhD preferred)
Experience in pharmaceutical or CRO clinical development, including a minimum of 10 years in clinical research
Strong expertise in protocol development, clinical study design, clinical study reports and clinical development planning
Demonstrated experience with regulatory interactions, including FDA Type B/C meetings, EMA/FDA Scientific Advice, IND/CTA and NDA/BLA/MAA submissions
Strong scientific, analytical and strategic thinking skills with the ability to evaluate opportunities, risks and development scenarios
Excellent stakeholder management skills with the ability to influence senior internal and external partners
Fluent in English; additional languages are beneficial
Excellent organizational skills, a proactive mindset and the ability to manage multiple strategic priorities
Willingness to travel internationally as required
Your department - where you make an impact
Within Global Clinical Research & Development, the Clinical Strategy team shapes the clinical development of innovative therapies from early development through registration and lifecycle management. We work closely with cross-functional partners worldwide to develop evidence-based strategies that ultimately improve patient outcomes and bring innovative therapies to patients around the globe.
Thrive with us
Company restaurant & meal subsidy
Training & further education
Health promotion
Parking spaces and good public transport connections
Company and team events
Enjoy these attractive benefits! You can find all offers here: Benefits
The minimum gross salary according to the collective agreement (chemical industry) is EUR 4.355,55 based on 38 hours per week (full-time). As we strive to offer a salary that reflects your individual profile and qualifications, there is a willingness to pay above the minimum salary.
It´s in our blood
We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.
Do you have any questions? Then get in touch with your contact person.
Passion for new health solutions advancing human life
Industry
Pharmaceutical Manufacturing
Company size
1,001-5,000 employees
Founded
1983
Headquarters
Springe, Lower Saxony
LinkedIn followers
4,121
Octapharma is the world's largest privately-owned, independent company specializing in the field of blood plasma fractionation. With over 11,000 employees, we lead in the development and production of essential human proteins derived from human plasma and human cell lines. We support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Hematology, and Critical Care.
Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US.
Out sites in Germany:
📍 Octapharma Produktionsgesellschaft Deutschland mbH, Springe
📍 Octapharma Dessau GmbH, Dessau
📍 Octapharma Biopharmaceuticals GmbH, Heidelberg, Frankfurt, Berlin
📍 Octapharma GmbH, Langenfeld
📍 Octapharma Plasma GmbH, Langenfeld
Community guidelines: https://bit.ly/3M8ioml
Offices: Wolfgang-Marguerre Allee 1, Springe, Lower Saxony 31832, DE · 42/26–32 Pirrama Rd, Pyrmont, AU · Oberlaaer Straße 235, Vienna, 1100, AT · Oberlaaer Straße 235, Vienna, 1100, AT · Nizami Street 96, Nasimi Raion, Baku Ekonomic Zone, AZ
Passion for new health solutions advancing human life
Industry
Pharmaceutical Manufacturing
Company size
1,001-5,000 employees
Founded
1983
Headquarters
Springe, Lower Saxony
LinkedIn followers
4,121
Octapharma is the world's largest privately-owned, independent company specializing in the field of blood plasma fractionation. With over 11,000 employees, we lead in the development and production of essential human proteins derived from human plasma and human cell lines. We support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Hematology, and Critical Care.
Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US.
Out sites in Germany:
📍 Octapharma Produktionsgesellschaft Deutschland mbH, Springe
📍 Octapharma Dessau GmbH, Dessau
📍 Octapharma Biopharmaceuticals GmbH, Heidelberg, Frankfurt, Berlin
📍 Octapharma GmbH, Langenfeld
📍 Octapharma Plasma GmbH, Langenfeld
Community guidelines: https://bit.ly/3M8ioml
Offices: Wolfgang-Marguerre Allee 1, Springe, Lower Saxony 31832, DE · 42/26–32 Pirrama Rd, Pyrmont, AU · Oberlaaer Straße 235, Vienna, 1100, AT · Oberlaaer Straße 235, Vienna, 1100, AT · Nizami Street 96, Nasimi Raion, Baku Ekonomic Zone, AZ