Associate Director / Director Clinical Research Scientist – Remote (East Coast only)

Biotech/Pharma company; New York (NY); Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a dynamic Associate Director or Director Clinical Research Scientist to lead clinical strategies and ensure the effective translation of clinical development plans into actionable operational deliverables. This pivotal role involves contributing to the scientific content of various clinical documents, including protocols and reports, and working collaboratively with cross-functional teams to drive clinical excellence. Candidates should possess a strong background in clinical protocol development, regulatory writing, and a solid understanding of the drug development process. If you are passionate about advancing clinical research and thrive in a collaborative environment, this opportunity is perfect for you.

Benefits

20-25% bonus

Initial stock grant

Qualifications

• 7+ years in pharma/biotech with strong clinical protocol development experience.
• Familiarity with ICH/GCP and statistical methodology is required.

Responsibilities

• Develop clinical documents and provide scientific input for clinical strategies.
• Collaborate cross-functionally and manage a small team.

Skills

Clinical Protocol Development

Clinical Data Review

Medical Writing

Regulatory Submission

Statistical Methodology

Oncology Knowledge

Education

Ph.D. in a scientific discipline

Advanced Degree in a related discipline

Job description

Associate Director / Director Clinical Research Scientist – Remote (East Coast only)

New York City Metropolitan Area

Company: Biotech/Pharma company

Summary:

We are currently working with a client looking to hire an Associate Director or Director Clinical Research Scientist responsible for Clinical Strategies to ensure translation of the clinical development plans into operational deliverables. This role will contribute to the scientific content of clinical program documents including Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, Submission Documents, Publications and other Scientific Material.

Description:

• Provide scientific input into clinical data review, development of clinical presentations and integration of analyses into clinical documents.
• Develop scientific content (authorship/review) and clinical documents including study synopses, protocols, protocol amendments, ICFs, IBs, CSRs, DSURs.
• Conduct clinical review and input for study conduct in collaboration with clinical sub team.
• Contribute to the development of scientific documents including conference abstracts, manuscripts and other scientific information in collaboration with internal and external stakeholders.
• Assist in the development of clinical/scientific components of regulatory dossiers and meeting material (INDs, BLAs/MAAs, Type B/C FDA meetings).
• Work cross-functionally with Clinical Operations, Statisticians, Medical Writing, Medical Directors, Clinical Development and Regulatory Affairs.
• Provide scientific input and support for cross-functional activities including Program Management, Publications, Medical Affairs, Commercial Development, and Business Development.
• Review medical & scientific literature and material including publications, conference abstracts and posters, research databases and provide relevant knowledge related to disease state and compounds.
• Manage a small group/team. AD will report to Director, Director will report to Sr. Director.

Required:

• Advanced Degree in a scientific or related discipline required; Ph.D. preferred.
• Minimum of 7 years of experience in the pharma/biotech industry is a must; 9 years for Director.
• Strong experience in developing clinical protocols, study conduct and review of clinical data, drug development process and ICH/GCP.
• Familiarity with statistical methodology and interpretation of clinical data.
• 5 years of experience in medical or regulatory writing and submission of regulatory documents.
• Experience in Oncology or related disease is highly preferred.
• Ability to travel for internal and external meetings when needed.

Position pays a competitive base salary plus 20-25% bonus and an initial stock grant.

Seniority level

Director

Employment type

Full-time

Job function

Science