Director Clinical Development
1 month ago
Benefits Offered
401K, Dental, Life, Medical, Vision
Employment Type
Full-Time
“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”
Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning research, we launched our first commercial product in CNS in 2020 and received approval for an expanded indication in 2021. Currently celebrating our 22nd anniversary, we have a strong pipeline with projects in preclinical development stage through Phase III. We celebrate science, welcome curiosity, expect collaboration and demand integrity and respect in all we do, create and deliver.
The Associate Director/Director Clinical Development, will be responsible for the leadership, oversight, and medical integrity of psychiatry studies/programs. This individual will monitor clinical studies, review and interpret clinical trial data, provide input into clinical study and regulatory communications and reports, and contribute to clinical development plans and strategy.
*This position is classified as a NYC headquarters position, but the role is currently working remote.
Job Responsibilities
- Provide cross functional Clinical Development leadership for internal and external team members in the delivery of clinical studies:
- Provide a role in the strategic planning of clinical studies and programs, including the development of study design, milestones, key deliverables.
- Provide support and oversight to all other functional areas of the study teams throughout the lifecycle of the study (startup, maintenance, closeout) in order to ensure data integrity, resolve and/or escalate issues, achieve alignment, and adhere to study goals and timelines.
- Act as primary contact for medical communication to ensure medical safety within studies. Develop and maintain relationships with sites and Investigators.
- Provide medical monitoring, which includes reviewing study participant eligibility, protocol interpretation, coding support, protocol deviation review, and data cleaning in collaboration with Clinical Operations and Data Management
- Work with Biometrics to contribute to the analysis and interpretation of clinical results
- Author, review, and/or provide strategic input into:
- Clinical sections of regulatory documents including, IND submissions, annual updates, DSUR, investigator brochures, and briefing documents
- Study specific documents such as study protocols/amendments, informed consent documents, case report forms, placebo justifications, and clinical study reports
- Scientific publications, manuscripts, posters, or other documents intended for external audiences
- Represent Clinical Development at Regulatory Authority Meetings
- Present the clinical development aspects of a project and clinical trial results at internal or external meetings
- Communicate to Senior Management and relevant functions any potential issues, risks or changes to the Clinical Development Plan
- Complete all company and job-related training as assigned within the required timelines.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
- Duties, responsibilities, and activities may change at any time with or without notice.
Job Requirements
- MD degree or international equivalent
- Specialty training in Psychiatry
- Minimum 1 year of relevant experience within the pharmaceutical, Biotech or relatable Industry
- Ability to travel at least 30%
- Ability to work in a team setting as well as function as an individual contributor
- Ability to work efficiently and under tight timelines
- Ability to communicate effectively
- Ability to be flexible in an ever-changing environment
- Ability to think strategically and be able to anticipate problems before they occur
- Ability to be proactive in finding solutions to issues
- Proficient in Microsoft Office (Word, Excel, PowerPoint)
- Must be able to perform all essential functions of the position, with or without reasonable accommodation
Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.
Associate Director Clinical Development Base Salary range $175K - $190K
Director Clinical Development Base Salary range $180K - $250K
#ITCI
-
Director Clinical Development
1 month ago
New York, United States Intra-Cellular Therapies, Inc Full timeBenefits Offered 401K, Dental, Life, Medical, Vision Employment Type Full-Time "We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders" Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning...
-
Director Clinical Development
4 weeks ago
New York, United States Intra-Cellular Therapies, Inc Full timeBenefits Offered 401K, Dental, Life, Medical, Vision Employment Type Full-Time "We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders" Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning...
-
Director Clinical Development
1 month ago
New York, United States BioSpace Full timeJob DetailsBenefits Offered401K, Dental, Life, Medical, VisionEmployment TypeFull-Time"We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders"Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning...
-
Director Clinical Development
4 weeks ago
New York, United States BioSpace Full timeJob DetailsBenefits Offered401K, Dental, Life, Medical, VisionEmployment TypeFull-Time"We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders"Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning...
-
Director Clinical Development
1 month ago
New York City, United States Intra-Cellular Therapies, Inc. Full timeBenefits Offered401K, Dental, Life, Medical, VisionEmployment TypeFull-Time “We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders” Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on...
-
Director Clinical Development
3 weeks ago
New York City, United States Intra-Cellular Therapies, Inc. Full timeBenefits Offered401K, Dental, Life, Medical, VisionEmployment TypeFull-Time “We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders” Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on...
-
Executive Director Clinical Development
1 week ago
New York, New York, United States Discover International Full timeWe partnered with a rapidly expanding biotech company specializing in Neurodegenerative Disorders. They boast a strong pipeline of 15 early-stage assets. Job Title: Executive Director/Vice President Clinical Development Lead the clinical development plan and overall strategy for multiple global programs Identify unmet medical needs in the...
-
Late Clinical Development, Medical Director
1 week ago
New York, New York, United States AstraZeneca Full timeJob DescriptionThe Late Phase Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally, in a matrixed environment, with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The Global...
-
New York, United States Roivant Sciences Full timeThe Medical Director/Senior Director will join the Clinical Development group and provide clinical scientific leadership for programs including direct responsibility for clinical development strategy and execution of clinical trials, with a focus in immunology, rare diseases and oncology. The optimal candidate will have the desire to proactively participate...
-
New York, United States Roivant Sciences Full timeThe Medical Director/Senior Director will join the Clinical Development group and provide clinical scientific leadership for programs including direct responsibility for clinical development strategy and execution of clinical trials, with a focus in immunology, rare diseases and oncology. The optimal candidate will have the desire to proactively participate...
-
Executive Director Clinical Development
4 weeks ago
New York, United States Discover International Full timeWe have have partnered with a fast growing biotech focused on Neurodegenerative Disorders. The client have a robust pipeline of 15 early stage assets.Role:Executive Director or Vice President Clinical Development creating clinical development plans for Neurodegenerative Diseases.Key ResponsibilitiesLead the clinical development plan and overall clinical...
-
Executive Director Clinical Development
4 weeks ago
New York, United States Discover International Full timeWe have have partnered with a fast growing biotech focused on Neurodegenerative Disorders. The client have a robust pipeline of 15 early stage assets.Role:Executive Director or Vice President Clinical Development creating clinical development plans for Neurodegenerative Diseases.Key ResponsibilitiesLead the clinical development plan and overall clinical...
-
Director of Development
2 weeks ago
New York, United States Village Health Works Full time**JOB TITLE**: Director of Development **REPORTS TO**: CEO **LOCATION**: NYC **ORGANIZATION BACKGROUND** Village Health Works (VHW) is a 501(c)(3) corporation. It is a social justice organization founded on the belief that health equity is not a commodity but a right. Founded in partnership with the communities we currently serve, VHW’s mission is to...
-
Clinical Director
1 month ago
New York, United States Tandym Group Full timeA social services organization in Brooklyn is actively seeking a compassionate and dedicated Clinical Director to join their growing staff. In this role, the Clinical Director will be responsible for the programmatic service delivery in partnership with the Program Director. Responsibilities: The Clinical Director will: Supervise the programs...
-
Clinical Director
2 months ago
New York, United States Tandym Group Full timeA social services organization in Brooklyn is actively seeking a compassionate and dedicated Clinical Director to join their growing staff. In this role, the Clinical Director will be responsible for the programmatic service delivery in partnership with the Program Director.Responsibilities:The Clinical Director will:Supervise the program's...
-
Clinical Director
2 months ago
New York, United States Tandym Group Full timeA social services organization in Brooklyn is actively seeking a compassionate and dedicated Clinical Director to join their growing staff. In this role, the Clinical Director will be responsible for the programmatic service delivery in partnership with the Program Director.Responsibilities:The Clinical Director will:Supervise the program's...
-
Clinical Director
1 month ago
New York, United States Women In Need, Inc. Full timeJob DescriptionJob DescriptionTitle of Position: Clinical Director FLSA Status: ExemptDepartment: Transitional HousingReports to: Program DirectorPositions reporting to this position: Client Care Coordinators and Case ManagersSalary: Up to $90,000/yearPurpose of the PositionThe Clinical Director is responsible for the programmatic service delivery in...
-
Clinical Director
1 month ago
New York, United States Women In Need, Inc. Full timeJob DescriptionJob DescriptionTitle of Position: Clinical Director FLSA Status: ExemptDepartment: Transitional HousingReports to: Program DirectorPositions reporting to this position: Client Care Coordinators and Case ManagersSalary: Up to $86,700Purpose of the PositionThe Clinical Director is responsible for the programmatic service delivery in partnership...
-
Clinical Director
1 month ago
New York, United States Women In Need, Inc. Full timeJob DescriptionJob DescriptionTitle of Position: Clinical Director FLSA Status: ExemptDepartment: Transitional HousingReports to: Program DirectorPositions reporting to this position: Client Care Coordinators and Case ManagersSalary: Up to $90,000/yearPurpose of the PositionThe Clinical Director is responsible for the programmatic service delivery in...
-
Clinical Director
4 weeks ago
New York, United States Women In Need, Inc. Full timeJob DescriptionJob DescriptionTitle of Position: Clinical Director FLSA Status: ExemptDepartment: Transitional HousingReports to: Program DirectorPositions reporting to this position: Client Care Coordinators and Case ManagersSalary: Up to $90,000/yearPurpose of the PositionThe Clinical Director is responsible for the programmatic service delivery in...
