Clinical Development Scientist

(Immuno-oncology focus)

 

 
Position #:                      1439
Therapeutic Area:          Immuno-Oncology               
Recruiting Status:          Exclusive Search
Location:                        Montgomery County Maryland
Why Available:               New position
 

Note:   Also seeking two Clinical Trial Project Managers   Link to job description:    Clinical Trial Project Managers

Note:   Also seeking VP/Director of Clinical Operations   Link to job description:      VP/Director, Clinical Operations

 

POSITION SUMMARY

The Clinical Development Scientist role is an exciting opportunity for a highly motivated individual to contribute to the development and execution of the clinical strategy and plans for our client’s Immuno-Oncology programs.

 

Through extensive interaction with the clinical development team, this individual will have an opportunity to make an impact through strategic and scientific input as well as the scientific support of the Company’s clinical programs.  He/she will use their scientific knowledge and experience to help build clinical expertise in the Oncology therapeutic area.

 

More specifically, this role collaborates with others on the team to design, plan, and implement the overall direction of clinical research projects including writing protocols, informed consent documents, Investigator’s Brochures. This individual will also coordinate activities to ensure compliance with protocol and overall clinical objectives as well as evaluate and analyze clinical data.

 

Essential Duties & Responsibilities

  • Contribute to the design of clinical studies in close collaboration with the Medical Lead as well as the entire Clinical Development team.

  • Write and coordinate finalization of clinical study documents (e.g., protocols, informed consent documents, and clinical components of investigator brochures) in compliance with regulatory standards.

  • Write draft manuscripts (paper, abstracts, posters, etc.) review and summarize relevant literature.

  • Organize expert panel, consultant, or advisory board meetings as appropriate to provide input to clinical plans

  • Provide clinical input to CRF design, statistical analysis plan, and drug supply planning

  • Collaborate with Clinical Operations in the identification and, evaluation, and selection of clinical sites and investigators, with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a time- and cost-effective manner.

  • Participate in site initiation visits as needed

  • Write protocol amendments, as necessary, to address safety, efficacy, or operational issues

  • In collaboration with Clinical Operations and the Medical Lead, Review protocol deviations (PD) reported by sites to identify the cause and appropriate resolution. Review PD trends and take appropriate actions, as needed.

  • Perform clinical data review and analysis of study results

  • Work with biometrics and other clinical team members in the review and interpretation of data

  • Assist in preparation of the clinical content of regulatory submissions / documents / meetings

  • In collaboration with the Communications team, responsible for the preparation of abstracts, posters, presentations, and publications.

  • Present clinical trial results internally and to the scientific community

  • In collaboration with the Pharmacovigilance Lead, review and track emerging efficacy and safety data, and take actions as appropriate

  • Perform and document regular review of individual subject safety data, and perform review of cumulative safety data with the Pharmacovigilance

 

Key Attributes

  • A high sense of urgency and personal initiative

  • A commitment to quality and excellence.

  • Strong scientific writing skills

  • Ability to work proactively and independently.

  • Effective verbal and written communication skills in relating to colleagues and associates both internal and external to the company.

  • Ability to work independently and successfully in a matrix environment,

  • Ability to prioritize and manage multiple tasks simultaneously.

  • Strong influence management, collaboration, and relationship building skills.

  • Detail oriented and ability to demonstrate.

  • Resilient and tenacious with the courage to challenge.

  • Highly analytical and strong problem-solving skills.
     

Education & Experience:

  • RN, MS, PhD or PharmD, with clinical research experience and a strong knowledge of drug development, or equivalent strongly preferred.

  • At least 3 - 10 years of technical operational experience in all phases of clinical trial planning, start-up, conduct, reporting and publishing required.

  • Experience in clinical oncology is required with recent immuno-oncology experience strongly preferred.

  • Extensive, direct knowledge of the clinical development process with the ability to understand concepts of various phases and principles of study design is required.

  • Experience with interacting with medical monitors, development operations) and clinical investigators

  • Thorough understanding of ICH, GCP, and relevant regulatory requirements is required.

 

NEXT STEP OPTIONS:

 

Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.

 

NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.

 

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