Clinical Scientist, Director Clinical Development

Who we are

The opportunity

The Clinical Scientist (CS), Director provides scientific expertise necessary to design and deliver clinical studies and is responsible for clinical activities of assigned program. This role partners closely with the disease area heads, clinical trial physician, and clinical lead, in developing the scientific and clinical strategy of assigned trials and/or programs. As part of the clinical development team, the CS will use methodological, analytical and scientific expertise to develop study designs in different phases of clinical development. The CS ensures the collection, analysis, review, and reporting of high-quality trial data in accordance with Clinical Development plans. The role requires a well—organized operationally focused individual with analytic skills and ability to deliver multiple tasks that can collaborate closely with cross-functional teams.  The CS is a member of the study team and CDT.

The role of the Clinical Scientist is to:

• Provide scientific expertise to the clinical studies (eg: protocol, Key Results, Clinical Study Report)
• Leads, plans and executes study level activities for one or more trials with minimal supervision
• Support other clinical development activities (e.g. medical review and validation of clinical data, study risk assessment)
• Contribute to the Protocol concept sheet, final protocol and protocol amendments and the clinical study report for their study(ies)
• Contribute to the clinical part of regulatory documents for their projects: Common Technical Document for FDA & EMA submission, PMDA, CA, etc and answers to questions from health authorities
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, clinical development team, and Investigators
• Be the clinical reference in the Clinical Study team related to clinical data

This role can be based in the Parsippany, NJ or the West Chester, PA locations.  

How you’ll spend your day

• 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).
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, site feasibility, and medical information to the study team, clinical development team, and investigators.
• Activities related to data generation and validation, including CRF (case report form) design, clinical data review/query resolution. Ensure continuous medical review of aggregated data during clinical trial conduct to identify trends and ensure quality data for database locks and interim cuts.
• Author or contribute to the development or review of medical related study documents (pre-defined protocol deviation list, the Informed Consent Form, narrative plan, study specific committee charter, etc).
• Support CRAs/CROs on study protocol and related questions and serves as a point of contact for managing/answering questions relating to trial procedures.
• Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
• Assist in the processing of responses to medical questions raised by EC/IRBs, sites.
• Review development of site and CRA training materials and presentation at site initiation visit and Investigator meetings and support on Study committee (e.g., DMC, protocol review committee).
• Support clinical aspects of Business Development and Licensing activities as needed.

Your experience and qualifications

• Advanced Degree required preferably in Life Sciences (MD, PhD, Pharm D, MS, RN or another scientific field preferred). Strong scientific background is required.
• A minimum of 5 years of experience in clinical development within pharmaceutical industry or CRO, specifically in clinical study design, data analysis, data review and interpretation is required.

Functional Knowledge:    

• Understanding of phase I-III drug development including knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development processes.
• Demonstrates knowledge and application of statistical analysis methodology and can identify data trends and interpret data effectively through the continuum of a study.
• Knowledge of Therapeutic Area (TA) preferred, with the capability to interpret, discuss and present trial or program level data.
• Maintain knowledge of the TA, disease state and potential drug effects 

Job-Specific Competencies:

• Excellent scientific communication skills, both verbal and in writing (English).
• Ability to communicate effectively with senior management and colleagues.
• Strong negotiation and conflict resolution skills.
• Strong presentation skills.
• Ability to work in a matrix organization environment.
• Highly self-motivated and proactive.
• Team player.

Travel for the role is expected to be less the 20%

Compensation Data

The annual starting salary for this position is between $227,000 – 297,000 annually.  Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate. 

Enjoy a more rewarding choice

Enjoy a more rewarding choice 

• We offer a competitive benefits package, including: 
• 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. 
• Additional benefits include, but are not limited to, 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 and more.  

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