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Medical Director

Company: Cymabay Therapeutics
Location: Newark
Posted on: June 6, 2021

Job Description:

Summary:

The Medical Director will report to the Vice President of Clinical Development. This position is responsible for planning and providing input for CymaBay's medical policies, standards, and programs as well as to design, implement and monitor clinical studies. The incumbent will also interact with biometrics personnel to plan data entry and analysis; recruit/screen/select competent investigators; plan content for investigator meetings; ensure that Good Clinical Practices (GCPs) are followed; ensure timely completion of studies; monitor data for safety and efficacy trends by reviewing clinical data; and ensure timely writing of clinical study reports upon completion or termination of studies. They will review requests of Investigational New Drugs (IND) studies and provide input for pharmacokinetics and pre-clinical studies; support development of clinical portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios and provide medical input to regulatory strategy and briefing documents.

Essential Functions and Job Responsibilities:

  • Provide clinical leadership for seladelpar for the treatment of Primary Biliary Cholangitis
  • Participates as key member of CymaBay's Clinical Development Team (CDT) to develop and maintain both strategic and operating plans for CymaBay's PBC development programs
  • Build, manage, and mentor clinical development professionals assigned to this role. This may include clinical scientists involved in medical monitoring and clinical drug safety.
  • Provide medical monitoring for studies to clinical investigators and internal/external team members (e.g., address medical and eligibility questions related to clinical protocols, answer product candidate related questions, etc.)
  • Oversee safety for assigned clinical studies (e.g., SAE reporting, ongoing review of events, integrated evaluation)
  • Responsible for coordinating the writing delivery of clinical sections to clinical and regulatory documents (e.g. clinical research plans, protocols (phase 1-4), clinical study reports, IB, and regulatory submissions). Develop, review and approve clinical protocols IB, ICF, eCRF, medical monitoring plans in collaboration with clinical scientists and applicable project team members.
  • In conjunction with medical affairs and other team members, establish, submit and execute seladelpar presentations for external meetings as well as publications in relevant peer-reviewed journals
  • Build and maintain medical expertise in the relevant fields to maintain and foster interactions at the highest possible level
  • Identifies and develops solutions for organizational and program and study level problems. Attends all CDT, applicable team and execution team meetings, as appropriate, with the goal of integrating clinical and cross-functional solutions to deliver program objectives.
  • Manages administrative responsibilities such as review and approve medical monitoring budgets, and personnel management for clinical staff assigned under this role
  • Ensure adherence to GCP/ICH standards and internal SOPs in the conduct and reporting of clinical studies
  • Support the Company in establishing and maintaining a work environment focused on quality and which fosters learning, respect, open communication, collaboration, integration, and teamwork
  • Complete other responsibilities as assigned and agreed upon

Minimum Qualifications:

  • M.D. or M.D./Ph.D.
  • Minimum of 4-5 years of experience in pharmaceutical or biotechnology setting and several additional years of clinical practice
  • Clinical development experience across all phases of product development and in multiple indications, to include roles in late-stage clinical trials, regulatory filings
  • Experience in hepatology/gastroenterology are preferred, but clinical experience or training in cardiology, endocrinology, nephrology, rheumatology/immunology will be considered. Experience in orphan indications is considered valuable.
  • Experience directly recruiting and managing clinical research staff
  • Thorough knowledge of FDA regulatory requirements, as well as knowledge of ex-US regulatory processes, and ICH/GCP guidelines are essential
  • Strategic thinker and creative problem-solver capable of identifying risks and risk mitigation strategies
  • Possesses excellent teamwork, negotiation and influencing skills, able to work in a matrix project team setting and a proven track record establishing and achieving clear and consistent goals and objectives
  • Excellent verbal and written communication skills
  • Must be willing and able to shift from a leader role to a "hands on" detail-oriented contributor

Keywords: Cymabay Therapeutics, Newark , Medical Director, Other , Newark, California

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