Associate Director Clinical Development (m/f/d)

Your Profile:

• M.D. with scientific and clinical background in Immuno-Oncology, Oncology
  
• Minimum of 3 years+ of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and/or the academic setting, including management of clinical development activities.
  
• Good understanding of the clinical and scientific methods and approaches used in clinical development, from FIH to registration; experience with regulatory processes and registration a plus.
  
• Experience in contributing to trial designs and protocols.
  
• Hand-on experience in managing the clinical day-to-day work for the successful delivery of clinical trials.
  
• Experiences in preparing global health authority interactions (e.g. EMA, FDA).
  
• Experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
  
• Ability to plan clinical activities based on a TPP and CDP guidance, and translating them into trial designs
  
• Experiences with working in a matrix environment (global and cross-functional)
  
• Experience in collaborating and communicating with external collaboration partners like KOLs and investigators.
  
• Good understanding of the science supporting the clinical development programs. Confident to discuss and present scientific and mechanistic aspects of drug development.
  
• Subject matter expertise on drug development topics, and genuine interest to drive innovation and continuous improvement
  
• Proficiency in English (written and spoken)

Your Tasks:

• Works hand-in-hand with the VP of Clinical Development to support development of clinical strategies, plans and their operationalization especially on trial level.
  
• Drives the operational planning, content, execution and delivery for our programs and studies. Will manage day-to-day clinical activities for our clinical studies including management of protocol amendments, overseeing data review activities and communicating with investigator / sites where appropriate.
  
• Assumes Program Lead responsibilities if assigned as clinical lead for a program; working hand-in-hand with VP Clinical Development to develop and implement CDP. Supports translation of Target Product Profile into clinical strategy.
  
• Collaborates with other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) to support clarity on clinical objectives, and drives alignment on objectives and expected outcomes especially on a protocol and clinical study level.
  
• Contributes to the trial medical/ safety aspects and risk-benefit assessments supported by the Clinical Trial Scientists and Pharmacovigilance.
  
• Collaborates closely with Pharmacovigilance on development of Risk Management Plans.
  
• Collaborates and gives guidance for the Clinical Trial Scientists, and works with them on day-to-day basis on clinical trials, driving overall progress of study implementation
  
• Supervises and gets involved in ongoing medical data review, ensures medical queries of running studies are resolved
  
• Ensures on program (where appropriate) and trial level, that the clinical development team works hand-in-hand with Clinical Operations team for patient centric drug development, ensuring balancing of high medical quality, trial complexity, as well as time and cost considerations
  
• Collaborates with other partner functions in Development on the acceleration of program and trial design and innovation for the patient (e.g. digital endpoints, synthetic control arms, RWE/ HEOR, PRO, Medical Affairs)
  
• Creates input for clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs.
  
• Writes/ co-writes Clinical Study Report (CSR) medical content and ensures it meets high quality expectations on medical standards.
  
• Manages relationships with key external stakeholders (industry partners, Key Opinion Leaders, health authorities), where appropriate.
  
• Represents the team to decision/ governance meetings, senior management, or advisory boards as applicable.
  
• Contributes to a collaborate culture within and outside Clinical Development and actively manages best practice sharing and capability building within the clinical team.

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