Job ID: 63510

Location:
Wien, AT

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Job Level: Professionals
Job Category: Research and Development
Employment Type: Permanent position

Career Level:
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.

Mrs. Johanna Proksch, MA

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Straße 235, 1100 Wien

T: +43 (1) 610 32 - 4299

Want to find out more about us?

Visit our website Octapharma Career and follow us daily on LinkedIn.

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About Octapharma

Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 195 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.