Clinical Scientist, Associate Director, Clinical Development
About The Position
The Clinical Scientist (CS), Associate Director provides scientific expertise to clinical studies and is responsible for clinical activities of assigned program. This role partners closely with the disease area (DA) heads, clinical trial physicians, and clinical leads, in developing the scientific and clinical strategy of assigned trials and/or programs. As part of the clinical development team (CDT), the CS will use methodological, analytical and scientific expertise to develop study designs in different phases of clinical development. The role requires a well-organized, operationally focused individual with analytical skills and ability to deliver multiple tasks in a fast-paced environment. The role also requires leadership skills and collaboration skills to work closely with internal and external cross-functional teams. This role can be based out of Parsippany, NJ or West Chester, PA. However, remote option may be considered for the right candidate meeting the requirements.
Requirements
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or another scientific field preferred). Strong scientific background.
- A minimum of 3+ years of experience in clinical research within pharmaceutical industry or CRO, or equivalent specifically in clinical study design, data analysis, data review and interpretation.
- Independently perform scientific literature searches, read and understand scientific and medical/clinical concepts and analyze relevant quality peer reviewed data
- Understand phase I-III drug development process including knowledge of Good Clinical Practice (GCP), clinical trial design, statistics, regulatory processes, and clinical development concepts/processes.
- Demonstrates knowledge and application of statistical analysis methodology and can identify data trends and interpret data effectively through the continuum of a study.
- Strong knowledge of Therapeutic/Disease Area (TA/DA), with the capability to interpret, discuss and present trial or program level data.
- Maintain knowledge of the TA/DA, disease state and potential drug effects
Responsibilities
- Provide scientific expertise to clinical studies (eg: protocol, Key Results, Clinical Study Report)
- Contribute to planning and execution of trials with moderate supervision
- Support other clinical development activities (e.g. medical review and validation of clinical data, study risk assessment, quality review of data, signal assessment and such)
- Contribute to the Protocol concept sheet, final protocol and protocol amendments and the clinical study report for their studies
- Contribute to the clinical part of regulatory documents for their projects: e.g. Common Technical Document (CTD) for FDA & EMA submission, Briefing Books, and develop answers to questions from health authorities
- Provide appropriate scientific and clinical input and support for all activities related to clinical studies: e.g. clinical development team activities, investigators training, site feasibility assessment, patients eligibility, Medical Management Plan, clinical review of data, IDMC and IAC activities and more.
- Become the clinical expert and the point-person in the Clinical Study team related to clinical data, protocol procedures and scientific expertise, as appropriate.
- Support the development of the protocol concept sheet, final protocol and protocol amendments.
- Contribute to the development, writing and review of the Clinical Development Plan (CDP).
- May lead or co-lead the CDT
- Ensure continuous medical review of aggregated data during clinical trial conduct to identify trends and ensure quality data for database locks and interim data reviews
- Author or contribute to the development or review of medical related study documents (pre-defined protocol deviation list, the Informed Consent Form (ICF), narrative plan, study specific committee charter, etc)
- Support CRAs/CROs and internal Teva personnel on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures
- Engage with investigators, site staff, CROs, external development partners and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies
- Contribute to the processing of responses to medical questions raised by EC/IRBs, sites
Benefits
- Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
- Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
- Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
- Life and Disability Protection: Company paid Life and Disability insurance.
- Employee Assistance Program
- Employee Stock Purchase Plan
- Tuition Assistance
- Flexible Spending Accounts
- Health Savings Account
- Life Style Spending Account
- Volunteer Time Off
- Paid Parental Leave, if eligible
- Family Building Benefits
- Virtual Physical Therapy
- Accident, Critical Illness and Hospital Indemnity Insurances
- Identity Theft Protection
- Legal Plan
- Voluntary Life Insurance and Long Term Disability
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
