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Medical Director

Medical Director

LanceSoftCambridge, MA, US
30+ days ago
Job type
  • Full-time
Job description

Remote

EST preferred, or CST

REQUIRED EDUCATION, EXPERIENCE, LICENSES / CERTIFICATIONS :

  • MD or internationally recognized equivalent plus 6 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical / clinical experience within academia (or a combination of afore mentioned).
  • Experience in rare disease and / or hematology area preferred
  • NDA / MAA / Submission experience preferred
  • Track record and demonstrated ability to lead and manage both science and business aspects of drug development.
  • Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals

Job Description for Medical Director, Clinical Science, Marketed Products Development

  • The Medical Director Marketed Products Development (MDMPD) Clinical Science is accountable for Medical Sponsor and Clinical oversight for assigned marketed products globally.
  • Participates in new business evaluation. Usually responsible for multiple products.
  • The MDMPD is an integral member of an Marketed Products Development Team (MPDT) in Global Medical that is responsible for providing dedicated support for the products under its purview.
  • The MDMPD interacts and partners with marketed products MPD affiliated function leads (regulatory affairs, global safety / pharmacovigilance, global development operations and project management) to set Global Medical strategy and prioritize functional area support for assigned MP portfolio.
  • This individual is responsible for medical and clinical scientific leadership for the assigned MPDT and product specific global program teams (GPT) or established product teams (EPT) as required.
  • The MDMPD provides Medical Sponsor Oversight for all assigned products managed by the MPDT as part of the dedicated, integrated functional area support to ensure the ability of Client to meet its corporate obligations as MAH for assigned products.
  • The MDMPD provides medical and clinical leadership to make sure that the MPDT anticipates potential compliance risks and has appropriate contingency plans in place to allow the rapid response to regulatory agency, scientific, or commercial hurdles.
  • The MDMPD will be required to be the medical and clinical scientific expert for the assigned products and to develop and maintain an up-to-date expert knowledge of the scientific, medical and regulatory aspects of the products in order to provide medical, clinical and scientific support, guidance, mentoring and leadership across these areas.

    • RESPONSIBILITIES AND ACCOUNTABILITIES :

    The Medical Director Marketed Products will be responsible for, and participate in the following activities :

    Marketed Product Clinical Science support & Leadership

  • Partner with Marketed Product Project Manager to coordinate functional support for assigned products within the MPDT. Provide medical and clinical scientific leadership and expertise for assigned products to support other function leads within the MPDT.
  • Establish integrated partnership(s) with MPD affiliated functional leads in R & D (regulatory affairs, global safety / pharmacovigilance, global development operations).
  • Collaborates with the commercial organization and Established Products Teams and Sub Teams
  • Form integrated partnerships and collaborate with all relevant cross-divisional stakeholders involved in the support of assigned products, including but not limited to, Quality, Global Manufacturing and Supply, Medical Affairs (Global and Regional), Global Commercial, LOC MDs, Regional Business Units (e.g., product brand leads) and LOC product leads.
  • Forms integrated partnerships with and works with Global Product Team Leaders (GPL) and Established Product Team Lead (EPTL) as necessary, and ensures excellence in delivery of medical and clinical support and execution of clinical development activities / studies across assigned products. Ensure the MPDT in Global Medical works effectively to support GPT / EPTs.
  • Medical Monitoring and supervisions and guidance for vendor medical monitors.
  • Forms integrated partnership with strategic partner vendor(s) and provide oversight of all strategic partner vendor medical and clinical deliverables for all products in assigned MPDT. Ensure highest quality of medical / clinical science input and clinical components of deliverables from the strategic partner vendor.
  • Partners with strategic partner vendor(s) and drives medical and clinical scientific activities relating to the preparation / approval of protocols and the conduct of clinical studies to support LCM, post marketing requirements and regional or local registration as needed. Provides Client oversight of strategic partner MDs / clinical staff involved in these activities. Accountable for the successful design, execution and interpretation of clinical studies.
  • Oversee the strategic partner vendor(s) to ensure appropriate and continuous medical monitoring and medical data review of clinical studies, protecting the safety of patients within the study. Responsible for internal oversight of strategic partner vendor medical monitoring activities, assessing issues related to protocol conduct and / or individual subject safety. Assesses overall safety information for studies and compound in conjunction with global safety / Pharmacovigilance. Makes final decisions regarding study conduct related to scientific integrity.
  • Establish integrated partnership with strategic partner clinical operations and statistical functional leads to ensure the integrity and correctness of data analysis and interpretation with the appropriate integration of safety and efficacy data from clinical studies longitudinally and cross-sectionally in support of regulatory submissions, ensuring data quality and adherence to national and international regulations and requirements and ICH.
  • Participates in cross functional non-project-specific initiatives and committees on behalf of project clinical perspective.
  • Presents study conclusions to management and determine how individual study results impact the product strategy. Interprets data from an overall scientific and regulatory standpoint as well as within the context of the medical significance to individual patients.
  • Participate in and support all required regulatory submissions / interactions for assigned products. Represent Client as Responsible Medical Doctor and Medical / Clinical expert to regulatory agencies globally for assigned products as needed. Support Local Operating Company (LOC) medical staff for all regulatory agency interactions as needed. Drive medical and clinical scientific input and development of required documents for regulatory applications / submissions (e.g. briefing reports, CTDs, IND updates, PSUR updates, label changes etc.), materials used for meeting presentations, and formal responses to communications received from the regulatory agencies.
  • Provide scientific education and mentoring for internal and external audiences (academic partners, scientific community, regulatory agencies)
  • Oversee compliance with internal SOPs and external legal requirements, including training of personnel, contractual arrangements with external service providers and partner companies.

    • External Interactions

  • Build and develop medical and clinical expert relationships to ensure delivery and maintenance of state-of-the-art medical therapeutic and clinical scientific expertise into medical and clinical support for assigned marketed products in Global Medical.
  • Participates in meetings with regulatory agencies as required
  • Represent Client on external bodies as needed.

    • Due Diligence, Business Development & Alliance Projects

  • Participate and conduct clinical due diligence evaluations and development of clinical development plans for potential alliances and or in-licensing opportunities.
  • Assess both scientific and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans.
  • Interacting with upper management of potential partner / acquisition companies during due diligence visits and alliance negotiations, and actively participating on internal assessment teams in conjunction with commercial colleagues.

    • REQUIRED EDUCATION, EXPERIENCE, LICENSES / CERTIFICATIONS :

  • MD or internationally recognized equivalent plus 6 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical / clinical experience within academia (or a combination of afore mentioned).
  • Experience in rare disease and / or hematology area preferred
  • NDA / MAA / Submission experience preferred
  • Track record and demonstrated ability to lead and manage both science and business aspects of drug development.
  • Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals

    • Skills

  • Superior communication, strategic, interpersonal and negotiating skills
  • Ability to proactively predict issues and solve problems
  • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
  • Diplomacy and positive influencing abilities across multinational business cultures

    • Knowledge

  • Emerging research in disease area and therapeutic approaches relevant to the assigned programs
  • Nonclinical and clinical drug discovery and development
  • TMS state-of-the-art technologies
  • Regional / global Regulatory requirements
  • GCP / ICH
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