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Senior Director Clinical Operations (f/m/d)

Ladenburg
Full-time
Permanent employee

Your mission

We are looking to hire a

Senior Director Clinical Operations (f/m/d)

in a permanent, full-time position, reporting directly to the Head of Clinical Development. 
Location: Ladenburg near Heidelberg or home based with regular visits to Ladenburg. 
 
As Senior Director Clinical Operations, you will be responsible for owning, managing and optimizing Heidelberg Pharma’s Clinical Operations function from A to Z:
  • You create and maintain the Clinical Operations Part of the Clinical Development Plan.
  • You review and further develop operational strategies of our ongoing projects to ensure that timelines,budgets and quality standards are met according to corporate goals. 
  • Provide a strong leadership role within the Clinical Operations Team and in conduction multiple clinical research trials across all functional areas of the drug development process. 
  • Report on study progress, timelines,milestonesand challenges.
  • Manage CROs over the whole processand attend investigator, kick-of for other vendor meetings.
  • Liaise with Clinical QA to ensure compliance with GCP regulations; ensure maintenance of SOPs and take the responsibility that CRO/vendor audits are completed

Your profile

  • You hold at least a MSc degree togetherwith a minimum of 8 years’ experiencein the field of clinical/ medicaldrug development. 
  • Demonstrated ability to lead people.
  • Extensive drug development experience in Phase I-III, experience with biologics and oncology preferred. Hands-on experience must include Phase I and II studies and global/international studies or programs. 
  • Being experiencedinproject management, financialplanningas wellasininteractions with national supervisory authorities, both in the EU andUS.
  • Experienced inselecting andmanaging clinical CROsand other critical service providers.
  • Ability to meet short deadlines in a dynamic biotech environment, including the rapid translation of operational strategies into clearobjectivesand deliverables. 
  • Very goodBusiness and Medical English complete your profile.

Why us?

  • Flexible working hours with compensation options and the opportunity to work remotely so that your job fits into your life
  • Mentoring program: In addition to comprehensive onboarding, you will receive a buddy who will show you everything so that you feel at home quickly
  • Prospects for your personal and professional development: Benefit from our training program so that you can take your qualifications to a new level
  • Look forward to 30 vacation days per year and additional days off on 24.12. and 31.12.
  • We support you and your family through our “FamPlus” Employee Assistance Program, e.g. in organizing childcare or caring for relatives
  • We offer you a wide range of social benefits: Company pension scheme with employer subsidy and benefits as part of company health insurance
  • You can use our free charging stations for your electric car
  • Happy coffee break, weekly fruit day and regular great company events await you

About us

As a medium-sized company based in Ladenburg near Heidelberg, we place great importance on an open and collegial work environment. We address each other informally, enjoy working as a team, and take responsibility for our areas of work. Together, we are developing a new treatment approach in oncology. Based on our ADC technologies, we are developing novel drugs for targeted and highly effective cancer treatment. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the potency of toxins to specifically target cancer cells. We use multiple payloads and have built an ADC toolbox that overcomes tumor resistance through diverse mechanisms and targets different types of cancer via various antibodies. Our goal is to develop targeted and highly effective ADCs for the treatment of a wide range of malignant hematological and solid tumors. 

We offer diverse positions in research, development, and administration. We support you on your personal career path and offer you a wide range of opportunities for professional development.

We welcome all applications regardless of origin, gender, age, physical characteristics, disability, religion, sexual orientation, gender identity, or any other criterion under applicable law. What matters to us are your strengths and experience. We promote diversity and equal opportunity by treating all applications fairly and avoiding discrimination.