Senior Medical Director, Clinical Development
3 weeks ago
SK Life Science (SKLSI) is seeking an experienced Director of Clinical Development-CNS to be involved in multiple product development projects. Working with cross-functional teams, the Director of Clinical Development will provide therapeutic and pharmacovigilance expertise to the clinical development of the SKLSI pipeline of therapeutic drugs with particular focus on epilepsy. The Director will partner closely with clinical operations to support each product development project. The Director will work with regulatory, discovery, business development, legal, quality and CMC to facilitate the development of SK Life Science products.
ResponsibilitiesGeneral:
- Training in Good Clinical Practices (GCP)
- Knowledge of relevant regulatory guidance for the clinical development process
- Experience with FDA and/or EMA preferred
Skills:
- Excellent cross-functional collaboration skills and must be able to work effectively in a team setting (including virtual teams)
- Evidence of ability to work with opinion leaders and clinical sites/investigators
- Excellent communication skills necessary to:
- Represent the Company externally in scientific presentations, conferences, industry groups and at Advisory Boards/Investigator Meetings
- Present to internal stakeholders including clinical and non-clinical audiences
- Interact with industry regulators
- Strong computer skills including MS office Suite (Word, Excel, PowerPoint, Outlook) and use of industry-standard software (e.g., electronic data capture systems) and proficient in data analysis software and data presentation
Responsibilities:
- Participate in the development of product development plans and lead clinical trial strategy for given project/program
- Participate in the design and conduct of clinical trials by providing oversight in collaboration with internal and external operations personnel (including CRO oversight for given projects/studies)
- Ensures projects/programs are delivered in compliance with GCP requirements and global ethical and regulatory standards
- Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials
- Provide medical expertise regarding product development or other scientific issues for drug discovery and development, and senior management
- Participate in pharmacovigilance activities including SAE evaluation and reporting and analysis of safety data
- Participate in preparation of protocols, Investigator Brochures, clinical study reports, safety reports, and the clinical sections of Annual Reports, INDs/IMPDs, NDAs/MAAs, SOPs, pediatric investigation plans, as well as abstracts and manuscripts
- Interface with regulatory agencies for clinical development programs and regulatory submissions when necessary
- Oversee the scientific interaction with relevant medical consultants/advisors and investigators
Education Preferred:
- M.D. Degree
- Practice experience preferable but not required
Work Experience:
- Minimum of 2 years of experience in clinical development in the pharmaceutical industry, preferably with neurology compounds or relevant academic research experience
Physical & Mental Requirements:
- Ability to multitask
- Adapts to change/flexible
- Maintain composure under pressure
- Ability to follow verbal or written instructions and use of effective verbal communication
- Examine and observe details
- Self-starter and decision maker
Other
- 10% travel
-
Senior Director, Head of Clinical Operations
2 weeks ago
Paramus, United States SK Life Science, Inc. Full timeOverview: To provide management oversight/leadership to the Clinical Operations group for all Phase I-IV studies at SKLSI. Assure implementation of consistent and complaint clinical trial processes for all SKLSI clinical studies. Responsibilities: Play leadership role in a matrixed multi-disciplinary team (CMC, Drug Supply, Regulatory, Pharmacovigilance,...
-
Clinic Director
2 weeks ago
Paramus, United States Forge Health Full timeAbout us: Forge Health is a mission-driven outpatient mental health and substance use provider dedicated to providing the highest quality, affordable, and effective "one-stop-shop" care to individuals, families, and communities in need. As the first and only behavioral healthcare provider with a proven, national payer-validated ability to drive clinical...
-
Senior Developer
1 week ago
Paramus, United States Russell Tobin Full timeThe Information Technology team at Russell Tobin & Associates is supporting a top service and utility organization that has an opening for a Senior ERP Developer.Location: Paramus NJ (Hybrid: 2 days/week in office minimum)Type: 12 months contract to HirePay Range: $60/H - $70/H, depending upon experienceDescription:The Senior ERP Developer will be...
-
Senior Developer
1 week ago
Paramus, United States Russell Tobin Full timeThe Information Technology team at Russell Tobin & Associates is supporting a top service and utility organization that has an opening for a Senior ERP Developer.Location: Paramus NJ (Hybrid: 2 days/week in office minimum)Type: 12 months contract to HirePay Range: $60/H - $70/H, depending upon experienceDescription:The Senior ERP Developer will be...
-
Senior ERP Developer
2 weeks ago
Paramus, United States Russell Tobin & Associates Full timeWhat are we looking for in our Senior ERP Developer? The Information Technology team at Russell Tobin & Associates is supporting a top service and utility organization that has an opening for a Senior ERP Developer.Location: Paramus NJ (Hybrid: 2 days/week in office minimum)Type: 12 months contract to HirePay Range: $60/H - $70/H,...
-
Director, Regulatory Affairs Strategy
8 hours ago
Paramus, United States NS Pharma Inc Full timeResponsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The Director will manage and lead regulatory strategy and submission related activities of assigned projects and manage direct reports, consultants and CROs...
-
Clinical Nutritionist
4 weeks ago
Paramus, United States NJ Veterans Memorial Home Paramus Full timeUnder direction of a Supervising Clinical Nutritionist and/or Clinical/Medical Director or other clinical/medical administrator, is responsible for evaluation of the nutrition status of assigned clients and develops nutrition care plans in compliance with federal, state and department standards; does related work as required. - **QUALIFICATIONS...
-
Director of Sales
7 days ago
Paramus, New Jersey, United States Sunrise Senior Living Full time: Sunrise Senior Living was again certified as a Great Place to Work® by Activated Insights. This is the 6th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise of Paramus Job ID: (phone number removed) JOB OVERVIEW: "Sunrise is the best place that...
-
Director, Regulatory Affairs Strategy
3 weeks ago
Paramus, United States NS Pharma Inc Full timeResponsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The Director will manage and lead regulatory strategy and submission related activities of assigned projects and manage direct reports, consultants and CROs...
-
Senior ERP Developer
7 days ago
Paramus, United States RSC Solutions Full timeLocation - Paramus, NJ - Hybrid (minimum 2 days per week in the office) Contracto to Hire W2 Role The Senior ERP Developer will be responsible for design, development, and implementation of ERP solutions to streamline business processes and drive operational efficiency The Senior ERP Developer will work closely with business and technology stakeholders to...
-
Director, Regulatory Affairs Strategy
4 weeks ago
Paramus, United States NS Pharma, Inc. Full timeResponsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The Director will manage and lead regulatory strategy and submission related activities of assigned projects and manage direct reports, consultants and CROs...
-
Senior ERP Developer
2 weeks ago
Paramus, United States HIGH BRIDGE CONSULTING LLC Full timeJob DescriptionJob DescriptionPOSITION PURPOSEProvide a brief description as to the primary purpose of this job (no more than three to five sentences).The Senior ERP Developer will be responsible for design, development, and implementation of ERP solutions to streamline business processes and drive operational efficiencyThe Senior ERP Developer will work...
-
Senior ERP Developer
2 weeks ago
Paramus, United States HIGH BRIDGE CONSULTING LLC Full timeJob DescriptionJob DescriptionPOSITION PURPOSEProvide a brief description as to the primary purpose of this job (no more than three to five sentences).The Senior ERP Developer will be responsible for design, development, and implementation of ERP solutions to streamline business processes and drive operational efficiencyThe Senior ERP Developer will work...
-
Senior ERP Developer
2 weeks ago
Paramus, United States V R Della Infotech Inc Full timeJob DescriptionJob DescriptionPOSITION PURPOSEProvide a brief description as to the primary purpose of this job (no more than three to five sentences).The Senior ERP Developer will be responsible for design, development, and implementation of ERP solutions to streamline business processes and drive operational efficiencyThe Senior ERP Developer will work...
-
Clinical Informatics Trainer
4 weeks ago
Paramus, United States Tandym Group Full timeA healthcare organization in New Jersey is actively seeking an experienced licensed healthcare professional to join their team as a Clinical Informatics Trainer / Analyst (RN/LMSW/LCSW). In this role, the Clinical Informatics Trainer / Analyst (RN/LMSW/LCSW) will be responsible for the implementation, optimization, and maintenance of the electronic medical...
-
Clinical Informatics Trainer
4 weeks ago
Paramus, United States Tandym Group Full timeA healthcare organization in New Jersey is actively seeking an experienced licensed healthcare professional to join their team as a Clinical Informatics Trainer / Analyst (RN/LMSW/LCSW). In this role, the Clinical Informatics Trainer / Analyst (RN/LMSW/LCSW) will be responsible for the implementation, optimization, and maintenance of the electronic medical...
-
Certified Med Tech
4 weeks ago
Paramus, United States Brightview Senior Living, LLC Full timeAbout Us: **We are honored that Brightview Senior Living has been recognized as one of Fortune Magazine's 100 Best Companies to Work For in 2023!!** **We're in the top 100 across all industries, and all companies no matter how large or small...and we're the ONLY Senior Living company on the prestigious list!** Overview: Are you the person who double...
-
Paramus, United States K.A. Recruiting Full timeLooking for a Molecular Management job? My name is Leah and I'm a healthcare recruiter, I'm here to help! I have a new Director of Molecular Genomics Laboratory position available near Paramus, New Jersey! Details - Full-time and permanent - Shift: Days - Full, comprehensive benefits package (PTO, health insurance, life insurance, 401k, etc) Job Summary The...
-
Senior ERP Developer PeopleSoft W2 ONLY Federal
2 weeks ago
Paramus, United States United Global Technologies Full timeThe Senior ERP Developer will be responsible for design, development, and implementation of ERP solutions to streamline business processes and drive operational efficiency The Senior ERP Developer will work closely with business and technology stakeholders to maintain SLAs for up time and support of business systems. The ERP Developer will work...
-
Paramus, United States United Global Technologies Full timeThe Senior ERP Developer will be responsible for design, development, and implementation of ERP solutions to streamline business processes and drive operational efficiency The Senior ERP Developer will work closely with business and technology stakeholders to maintain SLAs for up time and support of business systems. The ERP Developer will work...