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Senior Clinical Research Scientist

6+ years
Not Disclosed
10 Aug. 2, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

At Genmab, we are dedicated to shaping extraordinary futures by developing groundbreaking antibody therapies that transform cancer treatment and address serious diseases. With a focus on scientific innovation and a commitment to excellence, we aim to make a profound impact on patients' lives and the future of medicine. Our culture thrives on being uniquely authentic, determined to excel, and genuinely impactful.

The Role

As a Senior Clinical Research Scientist, you'll play a pivotal role within our Medical department, driving the global development strategy for one or more clinical trials. You'll oversee various aspects of clinical development, collaborate closely with the Medical Director, and work across functions to ensure high-quality, timely deliverables. Reporting to the Senior Director of Clinical Research, your responsibilities will include:

  • Leading or co-leading clinical trials in specific therapeutic areas for one or more compounds.
  • Developing and contributing to the program strategy and clinical development plans (CDPs).
  • Collaborating with the Medical Director to create clinical and regulatory documents, including protocols, informed consent forms, and study reports.
  • Developing case report forms (eCRFs) and providing scientific support for data management deliverables.
  • Leading the medical data review plan (MDRP), performing ongoing data reviews, and summarizing efficacy and safety data.
  • Engaging in site selection, feasibility assessments, and interactions with key opinion leaders (KOLs).
  • Coordinating internal and external committee meetings, including presentation preparations.
  • Providing input for publications and contributing to investigator meetings, CRO/CRA training, and site initiation visits (SIVs).

Requirements

  • PhD, Pharm D, MS, or equivalent degree in a relevant discipline (medical, biological, pharmaceutical sciences, or related field).
  • At least 6 years of clinical research experience, with a minimum of 3 years in drug development.
  • Prior experience in oncology/hematology drug development is a plus.
  • Strong skills in project-oriented, matrixed team environments.
  • Excellent communication skills, both oral and written.
  • Ability to travel as needed.
  • This role is based in Princeton, NJ, with a hybrid work arrangement.

Compensation

For U.S.-based candidates, the proposed salary range for this position is $114,375.00 to $190,625.00. Salary offers will be based on various factors including skills, qualifications, experience, and location. Additional compensation, such as bonuses, may be available for certain positions.

About You

You are passionate about our mission to transform cancer treatment and are committed to our scientifically-driven approach. You excel in collaborative, diverse teams and thrive in a dynamic, fast-paced environment. With a strong desire to innovate and a commitment to high-quality work, you are ready to contribute to our mission and have a meaningful impact.

Locations

Genmab fosters a flexible working environment to support a balanced work-life dynamic. Our open, collaborative office spaces are designed to connect employees, while remote work options are available to accommodate various needs.

About Genmab

Genmab is a leading biotechnology company dedicated to advancing antibody therapeutics. For over 20 years, our innovative team has developed cutting-edge technologies and formed strategic partnerships to deliver next-generation treatments. Our goal is to transform the lives of individuals with cancer and other serious diseases by 2030 through our proprietary pipeline of antibody medicines.

Commitment to Diversity, Equity, and Inclusion

Genmab is committed to creating a diverse and inclusive workplace where every employee is valued and respected. We do not discriminate based on race, color, religion, sex, national origin, age, disability, or genetic information. Learn more about our diversity commitments on our website.

Data Privacy

Genmab is dedicated to protecting your personal data. For details on how we handle your data in connection with your application, please refer to our privacy policy on our website: Genmab Privacy Policy.

Please note that for positions in the Netherlands, a fixed-term contract may be offered initially, with potential for renewal based on performance and business conditions.

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