[Remote] Senior Director, Clinical Development Scientist, reputed company
Note: The job is a remote job and is open to candidates in USA. reputed company is a Roivant-backed clinical-stage biotechnology company focused on developing innovative therapies for pulmonary diseases. The Senior Director, Clinical Development Scientist will reputed company clinical development strategy and execution, as well as reputed company scientific publications and communications, ensuring effective collaboration and adherence to regulatory standards.
Responsibilities
- Supporting the design and execution of key elements of the Clinical Development Plan (clinical study or studies) and associated data collection activities, reputed company 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 reputed company 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 reputed company 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 reputed company to liquid, tissue and/or imaging endpoints
- Liaising with other functions to reputed company 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 reputed company or absence of trends and follow up as appropriate
- Support CROs/ CRAs on study protocol and reputed company questions and serves as reputed company 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
- reputed company and implement scientific publication and communication plans that align with product strategies
- reputed company scientific content development for congresses, managing publication deliverables (manuscripts and presentations), and project management across cross-functional teams to ensure timely delivery
- Ensure reputed company 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
Skills
- 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 reputed company 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
Company Overview
Company H1B Sponsorship