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Head of Clinical Development, Oncology / Onco Hematology (f/m/d)

Ladenburg
Full-time
Permanent employee

Your mission

We are looking to hire a
 
Head of Clinical Development, Oncology / Onco Hematology (f/m/d)
 
in a permanent, full-time position, reporting directly to the Chief Executive Officer.
Location: Ladenburg near Heidelberg or home based with regular visits to Ladenburg.
 
As Head of Clinical Development and member of the Executive Management Team, you will overall be responsible for leading the Clinical Department (Clinical Development & Clinical Operations), managing the internal interfaces and the partnership to our strategic and operational external partners. Providing medical, scientific, strategic and operational leadership for the successful planning, execution, assessment, and reporting of the clinical trials run by Heidelberg Pharma includes the following responsibilities: 

  • You are accountable for the overall Clinical Development Strategy of our development portfolio and the creation of Clinical Development Plans, including FiH and PoC strategies, for clinical stage drugs and theimplementation into the Integrated Global Development Plan. Current focus is on Phase 1 and Phase 2 considering the needs for a Phase3 program and market access.
  • You are accountable for thepreparation ofhigh-quality study concept sheets, study protocols and study reports, Investigator Brochures, submission/registration documents, publications, etc.Also,you provide medical/scientific input and drive the creation of further relevant clinical documents, always working in a hands-on mode.
  • You provide medical expertise for the clinical operations team.Furthermore, you are an active team member of cross-functionalproject teamsand the Benefit/Risk Assessment Team. You alsoare accountable forappropriatevendor selectionprocess,vendorcontract negotiations,andvendoroversight (CROs, central laboratory, central imaging). 
  • In addition, you provide medical/scientific input into,e.g. business plan, project strategy, in-/out-licensingactivities,etc.as assigned. You are the scientific and medical expert in clinicaldevelopment with a strong interface tonon-clinical drug development. You manageKeyOpinionLeader interactions, maintain and develop KOLnetwork,establishand maintain relationships with scientific advisors.
  • Youwillrepresent HDP interests in e.g. Joint Development Committees and Joint Steering Committees established withpartnersasappropriate.
  • Furthermore, you liaison investigators, Institutional Ethics Committees/Institutional Review Boards, consultantsand academic institutions withinthearea of responsibilityand you prepare and participatein meetings with national supervisory authorities (e.g. EMA, FDA,BfArM).
  • Youare accountabletoensure adequate safety overview and medical monitoring of the trials including periodic safety updatesby the team or yourself,youorganizeand support DMCsas well as you assure compliance with ICH-GCP and other regulatory requirements.
  • Further you create and approve internal and external training materials and processes.

Your profile

  • You are a Medical Doctor with a minimum of8yearsprovenstrategic and operational leadership experience in the field of clinica ldevelopment and clinical operations
  • You are board certified in the field of Oncology or Hematology oryou have relevant professional experience in oncologicalor onco-hematologicaldrug development.
  • A very good understanding of clinical drug development, pharmacovigilance, biostatistics and GCPis required for this position.
  • Being experienced in interactions with national supervisory authorities (e.g. EMA, FDA,BfArM) is a plus.
  • You are assertive, highly process-driven and solution-oriented,and youhavethe ability towork incross-functionalteams as well as in matrix organizations 
  • Youpossessan organizational andplanning talent with excellent communication skills (written or spoken). You appreciate independent,structured and precise work.
  • You are a hands-on personalwayswilling to takeoveroperational tasks to drive the projects and balance theteam’sresponsibilities– the tasksaredriving theaccountability and responsibility.
  • Very good Business 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.