(Senior) Clinical Development Manager (m/f/d)

Helm Ag; Hamburg; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

HELM Pharmaceuticals, based in Hamburg, is seeking a Manager Clinical Development (m/f/d) to lead clinical development activities within Finished Dosage Form Programs. You will combine scientific expertise with strategic thinking to shape a high-quality development pipeline and support regulatory outcomes.

In this role, you collaborate with interdisciplinary teams and external partners to drive projects forward, coordinate trials, prepare regulatory submissions, and ensure GMP/GCP compliance

Qualifications

• University degree in a life‑science discipline.
• More than 3 years of experience in clinical research.
• Hands-on, structured, solutions-oriented mindset.
• Effective communication with interdisciplinary teams and partners.
• Experience with SAP or ERP systems.
• Fluent written and spoken English.

Responsibilities

• Ensure ongoing proof of efficacy and safety across lifecycle stages.
• Provide responses to scientific and regulatory questions on trial design and portfolio.
• Represent clinical development in interdisciplinary teams for generic development.
• Plan, coordinate, and supervise clinical and pre‑clinical studies per ICH GCP guidelines; prepare scientific advice packages.
• Prepare, coordinate, and review clinical documentation for regulatory submissions, including Modules 2.4 and 2.5; respond to deficiency letters.

Skills

Clinical research

Project management

Communication

MS Office

SAP ERP

Life science degree

English (fluent)

Education

Life science degree

Tools

SAP

Job description

Experience HELM as a unique family business and an attractive employer. Through a constant exchange of ideas, our ultimate goal is to offer our customers future-oriented solutions within our global network. At any time, in any place. This allows us to work proactively and think long-term - in operations, quality management, process optimization, product development and distribution. We are innovation drivers, possibility makers and a reliable partner, all in one.

(Senior) Clinical Development Manager (m/f/d)

Date: Sep 30, 2026

Location: Hamburg, DE, 20097

Business Unit: Pharma

Job Function: Product Development / Launch Management

Level of Experience: Mid-Career

At HELM Pharmaceuticals, based in the Headquarter in Hamburg, we develop generic pharmaceuticals.

To strengthen our team in the Finished Dosage Form Programs we are looking for a Manager Clinical Development (m/f/d) with a clinical life science background.
In this position, you combine scientific expertise with strategic thinking, you help shape a high‑quality development pipeline and contribute to strong regulatory outcomes. You will work closely with interdisciplinary teams and external partners to drive projects forward efficiently. This role offers you the opportunity to actively influence clinical development decisions and create real value for customers. Become part of a dynamic environment where your work has a real impact!

• You ensure the continuous proof of efficacy and safety for our developed products across all life‑cycle stages.
• Furthermore, you also provide qualified responses to scientific and regulatory questions related to trial design, evidence requirements, and portfolio selection
• In addition, you will represent our clinical development in interdisciplinary generic development teams with emphasis on clinical trials of medicinal products.
• As Trial Manager, you plan, coordinate, and supervise clinical and/or pre‑clinical studies in line with regulatory guidelines and maintain quality management of the entire trial program in compliance with ICH GCP. This also includes consultation and design of trial concepts with competent authorities and the preparation of scientific advice packages.
• Part of your role will also include the preparation, coordination, and review of clinical documentation and dossier content for regulatory submissions, ensuring , the timely delivery of non‑clinical and clinical documentation, including the commissioning and review of Modules 2.4 and 2.5.
  • In doing so, you respond to deficiency letters during registration procedures and manage corresponding customer inquiries.
  • Moreover, you identify, select, commission and collaborate with national and international service providers (CROs, monitors, consultants), including auditing and ensuring proper investigational medicinal product handling in line with GCP and GMP requirements.
  • Lastly, you collaborate with the project teams in due‑diligence processes and evaluate dossiers as part of in‑licensing activities.

  Your profile:

  • You hold a university degree in a life‑science discipline.
  • Moreover, you have a solid understanding of clinical research with more than 3 years of experience.
  • You combine scientific rigor with a hands‑on mentality and a structured, solution‑oriented way of working.
  • You communicate effectively with interdisciplinary teams and external partners and feel comfortable managing several projects simultaneously.
  • You are familiar with common IT applications within the framework of project management (MS Office). In top of that, you already gained experience in working with SAP or another ERP system.
  • Fluent spoken and written English skills complete your profile.

Every day, each one of us contributes to HELM's success with competence, the highest expertise and unique service. We reward this commitment - not only with international opportunities, possibilities for seminars and further training but also with benefits that offer optimal conditions to reach the perfect work‑life balance.