Pulmovant

Director, Clinical Development Scientist, Pulmovant

Pulmovant

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Job Level

Lead

About the role

  • Supporting the design and execution of key elements of the Clinical Development Plan (clinical study or studies) and associated data collection activities, within a therapeutic area.
  • Contribute to the development of study concepts, protocol designs, and study essential documents by liaising with other functions and arranging external expert consultations, as needed.
  • Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define the clinical strategy.
  • Collaborating on, or leading where appropriate, the preparation of clinical study related documents including protocols, charters, statistical analyses plans and summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
  • Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
  • Reviewing and synthesizing scientific literature and competitive intelligence to support study and program strategy
  • Supporting development of publications arising from studies and other relevant initiatives.
  • Where appropriate, serve as the SME for identification, translation, inclusion, implementation, and reporting related to liquid, tissue and/or imaging endpoints.
  • Liaising with other functions to enable quality clinical study execution, by ensuring knowledge of the protocol, implementing effective quality control procedures and monitoring their execution.
  • Participate in the development of clinical study protocol concept sheets and protocols, study operations manuals, and other study essential documents.
  • Participating in Investigator meeting planning and execution and/or site initiation meetings.
  • Monitoring, cleaning, analyzing, and reviewing safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
  • Support CROs/ CRAs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Finally, engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
  • Providing support for business development activities, such as due diligence and research collaborations.
  • Develop and implement scientific publication and communication plans that align with product strategies.
  • Lead scientific content development for congresses, managing publication deliverables (manuscripts and presentations), and project management across cross-functional teams to ensure timely delivery
  • Ensure all publications and communications adhere to international regulatory guidelines, ethical standards, industry standards and internal SOPs. This includes critically reviewing content for scientific accuracy and rigor.
  • Manage external vendors, medical writers, and the associated annual budget for publication and scientific communication activities.

Requirements

  • Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree).
  • Understanding of general (and specific) therapeutic principles including therapeutic area experience.
  • Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
  • Familiar with scientific literature searches and weighing of quality peer reviewed data
  • Ability to clearly communicate to internal and external stakeholders orally and in writing
  • Basics of strategic vs. tactical thinking.
  • Strong written and oral presentation skills.
  • Fosters a collaborative work environment; has skills demonstrating leadership and ability to lead by influence.
  • Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
  • Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
  • Engage in problem solving and non-linear thought, analysis, and systematic thinking.
Benefits
  • Equal employment opportunities
  • Prohibits discrimination and harassment of any type
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical research methodologydata analysisstatistical analysisscientific literature reviewclinical study protocol developmentsafety data monitoringefficacy data analysispublication developmentproject managementregulatory compliance
Soft Skills
communication skillscollaborative workleadershippresentation skillsstrategic thinkingproblem solvinganalytical thinkinginterpersonal skillsinfluencebusiness acumen
Certifications
M.S.Ph.D.Pharm D.MPH