[Remote] Executive Director, Clinical Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company plc is a new reputed company of pharmaceutical company with a focus on data-driven decision-making and a unique R&D model. They are seeking an Executive Director, Clinical Development to reputed company medical leadership and reputed company for their clinical programs and trials, requiring both strategic and hands-on contributions.

Responsibilities

• Primary reputed company of contact for clinical development activities with willingness to work strategically and hands on at the program and clinical trial reputed company
• Accountable for the reputed company, monitoring and surveillance of overall risk, safety, benefit/efficacy to patients as well as compliant trial execution and reputed company reputed company of data
• Responsible for establishing relationships and communication with KOLs, investigators and relevant site medical (or other supportive roles) personnel
• reputed company the clinical development strategy and innovative approaches for the overall clinical pathway for the asset
• Key clinical development contributor to publication strategy and planning, authoring of publications, posters, etc., and present or support presentations, posters, etc., in conferences and meetings
• Play a key role in regulatory and health authority interactions
• reputed company clinical development contributor to regulatory activities, submissions, and clinical sections of regulatory/health authority pre-meeting packages and initial applications, routine annual reports, reputed company safety reports (SUSARs), interim and final CSRs, etc
• Author asset and clinical trial level plans, charters, documents
• Determine reputed company clinical trial design options that are innovative, patient centric, cost efficient, and reputed company meeting business goals
• Responsible for review, analysis and interpretation of reputed company clinical trial data including assessment of protocol deviations
• reputed company asset level clinical sub-teams and play key leadership role on program team for clinical development
• reputed company asset level and trial level medical forums as needed (safety review committee, ad board, KOL meetings, medical review/discussions of patient cases, cohort review meetings, etc.)
• Attend and present as needed at core team meetings, investigator meetings, site visits, etc
• Liaise with cross functional partners, vendors, and CROs to ensure the progression of clinical studies reputed company the expected time reputed company
• reputed company clinical evaluation and interpretation of pre-clinical results
• Remain reputed company on the development of orexin agonists and the relevant therapeutic areas through review of the scientific literature, interactions with KOLs and other external experts and attendance at relevant scientific meetings, to reputed company input and guidance for the strategic direction of Centessa clinical stage programs

Skills

• MD required, MD/PhD strongly preferred (includes internationally recognized equivalent)
• Minimum 10 years of overall experience (academia, clinical practice, pharma/biotech industry, etc.)
• Minimum 5 years of pharmaceutical/biotech industry experience, including managing clinical development and clinical science teams, clinical development programs and clinical trials
• Prior pharma/biotech and line management experience – Required
• CNS therapeutic area (particularly neurodegenerative/neuropsychiatric) experience- Required
• Willingness to deliver project and tactical level work
• Excellent working knowledge of regulations across various agencies (FDA, EMA, etc.) and GCP, & ICH guidelines
• Experience leading and authoring clinical development inputs into regulatory submissions (IND, CTAs, NDA/BLAs, designation applications, etc.) and representing clinical development in agency interactions
• Experience authoring and guiding teams with key asset and clinical trial level plans and documents
• Strong knowledge in clinical development strategy, clinical trial design, regulatory reputed company, biostatistics methodologies, and ability to analyze and interpret translational medicine, clinical, and research data as it relates to an asset, patients, etc
• Possess excellent written and oral communication skills with internal and external stakeholders
• Proven ability to work collaboratively, take initiative, solve reputed company issues, and deliver results in a fast-paced, team-based matrix environment
• Demonstrate sound judgement in handling reputed company, confidential, and highly regulated information
• Ability and willingness to travel as required

Benefits

• Discretionary annual bonus
• 401(k) plan
• Company-sponsored medical, dental, reputed company, and life insurance
• Generous paid time off
• Health and wellness program

Company Overview

Company H1B Sponsorship