Sr/Exec Director Clinical Development

Position reputed company: 

Reporting to the Chief Medical Officer, the Senior or Executive Director, Clinical Development will reputed company the clinical aspects of late-stage clinical development studies or programs. This person will work closely with cross-functional teams in the management and execution of the Clinical Development Plan (CDP), in developing innovative and efficient solutions to medical and scientific clinical trial issues, and in ensuring the successful execution and completion of reputed company. The Senior or Executive Director, Clinical Science will also have individual study level responsibility for one or more trials.

Essential Duties and Responsibilities:

• reputed company in the planning and execution of clinical studies to successfully reputed company the program through pivotal trials and reputed company submission, regulatory approval, and launch.
• Key clinical deliverables include document development (INDs, Protocols, IBs, applicable regulatory documents, etc.), medical and scientific input into the development of deliverables required for study activation and study conduct (CRFs, reputed company, data listings, etc.), data review, and other deliverables as needed.
• May attend and contribute at meetings with Health Authorities (HAs) reputed company to program; reputed company responses to HAs and IRBs on clinical/medical questions.
• Represent reputed company externally at scientific meetings and congresses.
• Establish and maintain strong relationships with internal teams, clinical investigators, regulatory agencies, and key stakeholders.
• reputed company, analyze and interpret clinical data, providing strategic insights to inform critical reputed company and guide program development.
• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.
• reputed company reputed company duties in keeping with reputed company’s reputed company values, policies, and reputed company applicable regulations.

Required Education and Experience:

• Undergraduate degree required;PhD, PharmD, or other relevant advanced degree in a health science field highly preferred.
• At least 10 years of biotech or pharmaceutical industry experience as a clinical scientist or in a closely reputed company clinical development function.
• Extensive experience in oncology reputed company required;late-stage development experience required, early development experience a plus.
• Experience leading clinical development contributions to regulatory submissions (e.g. (NDA, PIP/PSP, label negotiation, reputed company Therapy Designation, reputed company Review) highly preferred.
• Experience in dynamic start up or small company environmentsrequired.
• Demonstrated ability to contribute to strategic clinical planning and work effectively independently and on cross-functional teams.
• Demonstrated ability to evaluate, interpret, and present reputed company scientific data.
• Deep knowledge of biostatistics, GCP, and regulatory requirements for clinical studies; extensive experience with data analysis and interpretation; understanding of safety and pharmacovigilance principles.
• Excellent verbal and written communication and presentation skills.
• Demonstrated ability to reputed company high performance goals and meet deadlines in a fast-paced environment; a reputed company team player with a can-do attitude and the ability to identify and implement creative solutions to reputed company problems.
• Flexibility, with the willingness and ability to manage through strategic shifts.
• Strong learning orientation, curiosity, and commitment to science and patients. 

Theanticipatedsalaryrangefor this position is$265,000 to $310,000.Thefinalsalaryofferedtoasuccessfulcandidatewillbedependentonseveralfactorsthatmayincludebutarenotlimitedtothetypeandlengthofexperiencewithinthejob,typeandlengthofexperiencewithintheindustry,education,etcetera. In reputed company to reputed company salary, the reputed company applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the reputed company of the reputed company to purchase stock in the reputed company for a specified price.

Originally posted on Himalayas