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Associate Vice President, Clinical Development

Company: Reata Pharmaceuticals
Location: Plano
Posted on: January 27, 2023

Job Description:

The Associate Vice President, Clinical Development will be a key leader supporting strategy and operational implementation of clinical activities to support the development of Reata's clinical assets. This position will involve extensive coordination with the Chief Medical Officer, external CROs and Reata's Clinical Development Team, Medical Directors, Biostatistics, Clinical Pharmacology, Clinical Program Operations, Bioinformatics, Regulatory Affairs, and Quality Assurance.

RESPONSIBILITIES:

  • Contribute medical and scientific clinical research experience to the development of overall strategy and objectives of the clinical development programs
  • Serve as the NDA Lead for the Clinical Development group and is responsible for conceptualizing and operationalizing the NDA process, modules, and other deliverables as they pertain to Clinical Development
  • Partner with regulatory department, driving IND and NDA submissions, IB authorship and updating, and communication with US and international regulatory agencies
  • Direct protocol development, including writing and reviewing protocols, and working closely with data management in constructing and supporting materials
  • Review/evaluate clinical data
  • Support of data analysis and assembly, including clinical study report writing, and contribute to the preparation of abstracts, presentations, and manuscripts
  • Lead program development, including working cross-functionally with all of the disciplines necessary for successful drug development, including manufacturing, quality assurance, regulatory, marketing, product development, legal, biostatistics, data management, and clinical operations
  • Maintain complete and in-depth knowledge of the scientific and technical characteristics of assigned compounds in development or planning phase
  • Participate on key committees, and be responsible for presenting successfully at high-level internal meetings and reviews
  • Forge alliances with Data Management, Pharmacovigilance, Medical Directors, and Medical Affairs to coordinate real-time availability of clinical trial data, assuring data integrity, including safety, efficacy, pharmacokinetic, and correlative studies data to provide consolidated information for trial progress
  • Review statements of work, master service agreements, and quality agreements as related to clinical programs
  • Responsible for clinical development plans, clinical trial protocols, clinical pharmacology, data analyses, clinical study reports, and other related clinical documents
  • Ensure with QA that all company clinical trials are conducted according to GCP and all applicable regulatory requirements, with a focus on the safety and medical monitoring aspects of the trials
  • Drive creation of and be accountable for clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities' questions
  • Collaborate with Medical Affairs and Commercial Teams to develop a strong group of Key Opinion Leaders
  • Develop publication plan and directly oversee timely clinical data communication
  • Support relationships among the clinical/scientific community and with external experts including Key Opinion Leaders AND/OR
  • Serve as an external spokesperson of the clinical programs in interactions with development partners, investigator meetings, and advisory boards

    CORPORATE COMMITMENTS:

    • Demonstrate commitment and support for company and department goals, objectives, and procedures
    • Represent Reata by developing collaborative relationships with industry colleagues and vendors
    • Demonstrate professionalism and adherence to moral, ethical, and quality principles
    • Participate in corporate and departmental meetings
    • Comply with applicable regulations, GCP, and corporate policies and procedures

      QUALIFICATIONS:

      • MD or MD/PhD, with strong academic qualifications, and demonstrated clinical development experience in a pharmaceutical or biotechnology setting
      • Knowledge of clinical development process and methods of scientific investigation, GCP, the FDA regulatory environment and guidelines, including study and protocol design
      • Board certification in Internal Medicine is required
      • Full subspecialty training in Nephrology is preferred, however other suitable training in Cardiovascular, Pulmonary, Endocrinology, or Diabetes, may be appropriate
      • Excellent working knowledge of FDA, EMA, and PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Experience in representing the sponsor in front of regulatory agencies
      • Experience leading cross-functional members (CMC, Clinical Pharmacology, Medical Affairs, Regulatory, and Commercial) in program teams
      • Demonstrate expertise in clinical design and implementation of Phase 1 to Pivotal Clinical studies, with evidence-direct leadership of trials that meet the timelines, budget, and expected outcomes and lead to the regulatory success of innovative medicines
      • Significant Phase I-IV clinical trial experience and a strong history of involvement and contribution in the filing of NDAs
      • Sound medical/scientific writing skills and ability to analyze and interpret efficacy and safety data
      • Direct experience in clinical development of biologics and small molecules
      • Knowledge of statistical concepts as they relate to clinical plans
      • Knowledge of clinical pharmacology
      • Knowledge of adaptive trials and design of trial to support accelerated approval under accelerated and Restricted Approvals Under Subpart H and Subpart E
      • Experience managing clinical CROs from RFP to statements of work to coordinating execution
      • Knowledge of the day-to-day medical monitoring of clinical trials (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports)
      • Knowledge in pharmacovigilance, including the receipt and processing of ADRs, completion of MedWatch forms, and generation of Periodic Safety Update Reports
      • Strong communication and collaboration skills
      • The ideal candidate will have a network of external thought leaders, who serve as advisers
      • Excellent leadership, management, and organizational skills, along with problem-solving, conflict resolution, and team building
      • Must demonstrate highly refined analytic and communication skills, and the ability to work effectively, both independently and in a team environment
      • Willing to travel to support clinical and corporate activities

Keywords: Reata Pharmaceuticals, Plano , Associate Vice President, Clinical Development, Executive , Plano, Texas

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