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Senior Medical Director Clinical Development

  • Location: San Diego
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 21 days ago

Senior Medical Director/ Medical Director Clinical Development




The Senior Medical Director/ Medical Director Clinical Development will oversee the direction, planning, execution, and interpretation of the assigned clinical trials, protocols, and the data collection activities for one or more clinical trials. This position will develop and implement clinical strategies and be responsible for the oversight of contracted personnel and/or organizations. He or she will also serve as a liaison between the company and clinical investigators and will maintain established and productive relationships with key opinion leaders and Health Authority representatives. The ideal candidate must have in-depth knowledge and experience in oncology , with experience and expertise in the design and conduct of early and late-stage clinical studies. This individual will also manage program development, including working cross functionally with all the disciplines necessary for successful drug development: the CROs as well as pre-clinical, quality assurance, regulatory, legal, biostatistics and data management, pharmacovigilance, and clinical operations functions.

This position works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all company functional areas and its global office sites is essential.

Responsibilities

  • Formulate study designs for assigned immune-oncology programs, lead protocol development, and collaborate with cross-functional teams in study start-up activities in collaboration with clinical investigators, key opinion leaders and Health Authorities.
  • Clinical deliverables may include clinical sections of individual protocols consistent with the asset development plans, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
  • Directs protocol implementation including site identification and communication, attendance at investigators' meetings, correspondence with sites including and interaction with operations teams
  • Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration
  • Monitors clinical trials including the oversight of all aspects of trial conduct and safety, contact with investigators and site study staff
  • Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
  • Provides support in ensuring overall safety for the assigned section, may be a core member of the Product Safety and Risk Management Team, and supports overall program safety reporting (e.g., Periodic Safety Update Reports, Drug Safety Update Reports, and other safety related documents) in collaboration with Safety & Pharmacovigilance
  • As a medical expert, supports interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups) and internal stakeholders
  • Supports data analysis and assembly, including clinical study report writing, contributes to the preparation of abstracts, presentations, and manuscripts
  • Interacts closely with the Regulatory group and regulatory agencies, taking part in IND submissions, investigator brochure authorship and communication with US and international regulatory agencies
  • Must possess sound scientific and clinical judgement with ability to properly interpret clinical trial data.
  • Remains up to date with current information on pharmaceutical regulations, guidelines, and practices, as well as therapeutic area knowledge to ensure consistent best practices across all activities.

Qualifications

  • M.D. and Board Certification or Board Eligibility in the field of Medical Oncology, with clinical experience and/or expertise in Oncology.
  • Training and board eligibility in oncology preferred.
  • 5 to 10 years of experience in clinical research including the design and execution of clinical trials, within a pharmaceutical or biotech environment.
  • 2-5 years of industry experience preferred in clinical development or related area that includes oncology, preferably, oncology
  • Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience with FDA and other health authorities strongly desired.
  • Must possess sound scientific and clinical judgement with ability to properly interpret clinical trial data.
  • Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents.
  • Good working knowledge of drug safety databases (preferably ARGUS) and MedDRA.
  • Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
  • Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel.






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