Senior Clinical Development Leader Oncology/Immuno-Oncology

Type of contract: Permanent

Location: Whippany (US), Basel (CH) or Berlin (Germany) or London (UK)

Our client is a global Life Sciences enterprise, which products and services are designed to benefit people and improve their quality of life. There you have the opportunity to be part of a culture where the passion of the employees to innovate is highly valued, and they are given the power to change.

The company is currently looking for a Senior Clinical Development Leader for two of their business units - Oncogenic Signaling and Immuno-Oncology.

Tasks and Responsibilities:

  • Be responsible for the design and execution of the clinical strategy of early assets based on deep scientific and disease biology understanding, translational expertise and medical knowledge, including patient safety and data integrity
  • Lead the Global Early Clinical Development (ECD) Team, a cross functional multinational team of internal experts, from candidate selection to the design and execution of the required exploratory clinical studies and advancement to registration studies
  • Represent the ECD at the Global Project Team
  • Create and translate Target Product Profile into clinical strategy
  • Be responsible for the medical section of the protocol
  • Oversee the assessment of study safety and efficacy data and ensure appropriate contact is in place for study medical and patient safety aspects
  • Be responsible for study medical/safety aspects and risk-benefit assessments supported by Pharmacovigilance and Clinical Trial Scientist
  • Ensure Clinical Study Report (CSR) medical content adheres to acceptable medical standards
  • May supervise employees, both directly and indirectly through a matrix structure
  • Develop high impact relationships with internal partners across research, translational science, and clinical development functions
  • Establish, lead, and manage relationships with key external stakeholders (e.g. Key Opinion Leaders, health authorities)
  • Represent the team to other decision/governance meetings, senior leaders.

Qualifications and Skills:

  • M.D., M.D./Ph.D. or equivalent degree. Oncology / Hematology board certification is a plus.
  • Passion and track-record for developing novel cancer drugs based on a deep understanding of therapeutic science and clinical landscape
  • 8+ years’ experience in exploratory clinical drug development within a pharmaceutical / biotech environment, or as an academic investigator
  • Experience in Oncology and/or Immuno-Oncology
  • Understanding of the scientific methods and tools used in early development studies, biomarkers, translational modeling, biostats and a good understanding of Oncology medical needs and clinical trial landscape
  • Participated in clinical oncology studies with molecular targeted or immunological therapies
  • Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics)
  • Experience with health authority interactions globally
  • Participated and preferably led a drug development program to registration or IND filing
  • Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions
  • High energy with focus and vision; self-motivated with a high sense of urgency, proactive and solutions-oriented
  • Ability to develop and implement strategic growth plan
  • Strong consensus-building skills and the ability to lead multidisciplinary teams towards sound decision-making
  • Excellent communication skills, high level of comfort/success working in a matrix environment (global/multi-cultural/cross functional), including
  • contributing daily to building trusting, establishing clarity, collaboration and driving results;
  • Provide subject matter expertise and mentor others;
  • Networking and alliance management.

If you believe you could be the right candidate for this position, please send us your most recent resume to:

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