Clinical Trial Leader (all genders)

About MiGenTra

ProBioGen is looking for a Clinical Trial Leader on behalf of MiGenTra:

MiGenTra is a healthcare transforming medicines company, and a subsidiary of ProBioGen, with a focus on high quality medicines at affordable prices. The parent companies ProBioGen and Minapharm Pharmaceuticals announced the incorporation of "MiGenTra" in late May 2021.

Headquarters are in Berlin with access to a site in Cairo, which will house its principal manufacturing plant. The formation of MiGenTra accelerates ProBioGen's 2030 growth roadmap and showcases that further growth is not limited to the ongoing capacity increase but reveals one of several significant steps in the diversification of ProBioGen's business.

The company allows for product development in the field of Biosimilars, Cell- and Gene Therapies and vaccines especially for Egypt, the Middle East and Africa, and will therefore provide access to key healthcare transforming medicines, while strengthening regional and local manufacturing capacity in the region.

MiGenTra combines the scientific and manufacturing expertise from both contributing companies, ProBioGen and Minapharm Pharmaceuticals. It is established for product development and commercialization in the field of Biosimilars, Cell- and Gene Therapies (CGT) and vaccines, capitalizing on the strong development capabilities of ProBioGen and the excellent market position of Minapharm in the region.

Your Key Responsibilities

• Independent planning and GCP conform execution of international and national clinical studies (phases I-III) in different therapeutic areas including trial start-up, conduct, and close-out activities
• Coordination of a cross-functional study team including collaboration with one or more CROs
• Management of study execution including feasibility, centre selection, recruitment, timelines, vendor management and trial master file
• Review and/or compilation of study documents like study protocol, patient information, submission documents, CRF, study manuals
• Identification and optimization of processes to increase internal quality standards and efficiency
• Participate in and facilitate CRO/vendor selection process for outsourced activities
• work with CRO to develop and revise the scope of service agreements, budgets, plans, and detailed timelines and ensure that performance expectations are met
• Organize and manage internal team meetings, investigator meetings, and other trial-specific meetings
• Serve as a liaison and resource for investigational sites
• Manage set-up and testing of electronic data management system at CRO
• Cooperation with other departments of the organization or related affiliates (e.g. MiGenTra, MiGenTra Egypt and Minapharm departments such as marketing, regulatory affairs, QA, engineering and production as well as Probiogen departments) and external parties
• Internal presentations and seminars
• Clinical budgeting responsibility
• Organization and participation in group leader seminars
• Structuring and recruitment of clinical department staff
• Proactively identify potential study issues/risks and recommends/implements solutions
• Data processing and management
• Prepare metrics and updates for management
• Preparation of presentations and publications
• Reporting on Minapharm´s Internal Reporting-System (IRS)

Your Profile

• Study and degree in medicine, sciences, pharmacy, biotechnology or equivalent
• Minimum five years of clinical trial management experience in pharma/biotech/CRO
• Profound experience in planning and execution of clinical studies as clinical trial manager, project manager in clinical research or in a CRO
• Secured knowledge of ICH-GCP guidelines and other relevant regulatory requirements
• Ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required
• Experience in the field of oncology preferred
• Experience in cell and gene therapy a plus
• Excellent oral and written communication skills in English
• Excellent planning and organization skills as well as self-dependent, precise and solution-oriented personality

Your Benefits

Sphere.
Modern working environment with a familiar and open working atmosphere.

Balance.
Flexible and family-friendly working time model, as well as special leave days for Christmas and New Year.

Care.
Subsidy for company pension plan with salary conversion.

Health.
Discounts at the Urban Sports Club, yoga offers, shiatsu treatments and health days.

Taste.
Cafeteria with HelloFreshGo fridge, daily fresh lunch from the online cafeteria Smunch - discounted due to tax benefits -, free drinks such as coffee specialties and filtered water.

FeelGood.
Special goodies for all our creative ProBioGen minds around holidays and at internal events.

Nature.
Sustainable in many facets, whether with glass water bottles for each employee and corresponding water dispensers per floor, with the implementation of our occupational safety or with our digital transformation.

Advance.
Onboarding, mentoring program, innovation days, training & workshops.

BeneFit.
Individual bonus after three years of service.

Any questions?

We are happy to help!
ProBioGen AG
People & Organizational Development
Tel. +49 (0) 30 322935 133
beatrice.wiesner@probiogen.de