Medical Director

Seeking a Medical Director/Senior Medical Director with drug development, safety/pharmacovigilance and clinical trials experience to participate in the exploratory clinical development and safety management of new agents for the treatment of cancer. The position will involve clinical trial development with novel anti-cancer therapies. The Medical Director will act as a clinical representative to a number of cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within one or more programs. They will also participate in review of the safety database/serious adverse events and assist in developing the safety/risk management plans and long-range strategic plans for the molecule or molecules.

 

 

Key responsibilities:

  • Act as global medical/safety monitor for assigned clinical trials

    • Oversee all medical/scientific/safety aspects of assigned clinical trials, including identifying study sites, reviewing of eligibility data, reviewing patient profiles (safety and efficacy) on an ongoing basis, reviewing query generation, working closely with global Clin Ops, Data Management, Medical Writing, etc.

    • Direct protocol implementation, including site identification and communication, attend investigators’ meetings, correspond with sites including IRBs, and interact with operations teams.

    • Collaborate with global team members (e.g., Clin Ops, PVG, Stats, Data Management, Medical Writing, etc.) on trial execution

    • Provide medical expertise in the development, review and approval of Case Report Form (CRF) design, Informed Consent Form (ICF) design, site source documents, etc.

    • Review and approve Statistical Analysis Plans (SAPs) and all tables/plots, prepared or designed by Department of Biostatistics for clinical statistical analysis;

    • Lead the review, analysis and interpretation of study data

    • Support data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts.

    • Responsibility for medical assessment, medical review, signal detection and health hazard evaluation activities

    • Provision of individual case medical assessment and review and periodic report medical review.

    • Review the listing and narrative summaries for regulatory submissions including annual reports for NDAs and INDs, and integrated safety summaries.

    • Prepare and review of ad hoc documents required in response to requests from the FDA and other regulatory agencies.

 

  • Work with internal resources or outsource partners to oversee and manage all drug safety and surveillance activities for clinical trial phases.

  • Utilize epidemiology tools and medical judgment to conduct ongoing evaluation of potential safety signals.

  • Provide medical input to the assessment of emerging safety information, from clinical trials.

  • Contribute to safety sections of product labeling reviews.

  • Supervise the performance of safety contractors.

  • Interact closely with the regulatory department and regulatory agencies, taking part in IND submissions, IB authorship, and communication with US and international regulatory agencies.

  • Prepare, review, and approve the clinical study and safety related portion for INDs, NDAs (such as Sections 2.7 and 2.5 for NDAs), ANDAs or their amendments or supplements;

  • Prepare, review, and approve product labels and packaging inserts for NDA submissions.

  • Provide medical expertise in the review of adverse events (AEs) and manage pharmacovigilance activities;

  • Make final determination as to whether an Adverse Drug Event (ADE) is serious, unexpected or periodic;

  • Respond to FDA's possible questions regarding medical/safety matters during FDA interactions.

  • Attend in-person meetings and teleconferences with the FDA or other regulatory or business entities in conjunction with other Company team members to represent the Company regarding medical affairs, medical issues, safety concerns, ADEs, clinical trial results, drug development pipeline, etc

  • Medically evaluate safety data and develop R&D risk management initiatives

 

 

 

  • Serve as content owner for assigned clinical trial and other documents where clinical/medical is identified as the content owner

    • Conduct protocol development to include working closely with medical writing and project teams.

    • Write the clinical sections and review of all clinical documents related to the assigned clinical studies (e.g., study protocols and study reports), as well as contributing to related study documents, e.g., Investigator Brochure

    • Provide medical/scientific input and driving/contributing to the creation of these documents, or parts thereof

    • Collaborate with other contributors to these documents to ensure overall consistency and quality

 

  • Participate in program development, including working cross-functionally with all of the disciplines necessary for successful drug development: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management, pharmacovigilence, and clinical operations.

  • Interact 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.

  • Demonstrate independence, initiative and the ability to thrive in a fast-paced environment.

  • Travel time is approximately 20% including visits to investigative sites, regulatory agencies, and attendance at major oncology meetings.

 

 

 

 

Candidates should have an M.D. with board certification in Oncology or Hematology/Oncology. Experience in clinical trials, drug development and pharmacovigiliance/safety are preferred.

Effective oral and written communication skills are required, as are excellent interpersonal skills with demonstrated ability to work with a small growing team. The candidate should have the desire to proactively participate within a multi-disciplinary team of colleagues and the ability to interact with external experts and investigators. Minimum 3 years of pharmaceutical industry experience with 1 years of those in Oncology/Hematology and in Drug Safety and Pharmacovigilance.

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