Senior Clinical Research Scientist

6+ years

$114,375.00-$190,625.00

Plainsboro

10 Sept. 30, 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, CPC Certified, 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

About Genmab

At Genmab, we are dedicated to building extraordinary futures together by developing innovative antibody products and groundbreaking therapies that transform the lives of patients and redefine cancer treatment. Our culture is rooted in care, candor, and a drive for impact. We believe that embracing our unique qualities and striving for authenticity is essential to fulfilling our mission.

The Role

As a Senior Clinical Research Scientist in the Medical department, you will play a vital role in implementing the global development strategy. You will lead or co-lead one or more clinical trials in a therapeutic area for various compounds at different stages of development. This includes overseeing clinical trial implementation and collaborating closely with the Medical Director and cross-functional teams to ensure high-quality, timely deliverables. You will report to the Director of Clinical Research.

Responsibilities

Lead or co-lead clinical trials in a therapeutic area for multiple compounds.
Collaborate with the Medical Director and senior Clinical Research Scientists on program strategy and clinical development plans (CDPs).
Assist in creating clinical and regulatory documents, annual safety updates, and registration dossiers (including protocols, informed consent forms, and study reports) to support compound registration and commercialization.
Develop case report forms (eCRFs) and guidelines, providing scientific support for key data management activities.
Lead the medical data review plan (MDRP), perform ongoing data analysis, and summarize efficacy and safety findings.
Contribute medical insights for country/site selection and feasibility assessments, as well as engage with key opinion leaders (KOLs).
Prepare charters and coordinate internal and external committee meetings, including presentations for Dose Escalation Committees, Data Monitoring Committees, and Safety Committees.
Participate in developing and reviewing study plans, acting as a liaison to project teams and contract research organizations (CROs).
Provide input for publications in collaboration with Scientific Communications.
Support training at Investigator meetings, CRO/CRA training, and site initiation visits (SIVs) as needed.

Requirements

PhD, PharmD, MS, or equivalent degree in medical, biological, pharmaceutical science, or a related discipline.
A minimum of 6 years of clinical research experience, including at least 3 years in drug development.
Prior experience in oncology or hematology drug development is a plus.
Proven ability to work effectively in a project-oriented, matrixed team environment.
Excellent oral, written, and interpersonal communication skills.
Willingness to travel as needed.

For US-based candidates, the proposed salary range for this position is:

$114,375.00 - $190,625.00. Actual salary offers will consider various factors, including skills, qualifications, experience, and location. Certain positions may also be eligible for bonuses and other compensation.

About You

You are passionate about our mission and genuinely care about transforming patient lives through innovative cancer treatments.
You bring rigor and excellence to your work, firmly believing in a science-driven approach to problem-solving.
You are a generous collaborator who thrives in diverse teams.
You are determined to excel and take pride in enabling the success of your colleagues.
You embrace challenges and innovate without fear.
You have experience or a strong desire to work in a dynamic, fast-growing company.
You work hard while enjoying the journey.

Locations

Genmab promotes an agile working environment to enhance work-life balance. Our offices feature open, community-focused spaces designed to connect employees while immersing them in our state-of-the-art laboratories. Whether working from our collaborative office spaces or remotely, we prioritize connectivity to drive innovation.

Commitment to Diversity, Equity, and Inclusion

Genmab is committed to fostering diversity at all levels of the organization, which we believe is essential for our continued success. We ensure that no applicant is discriminated against based on race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. For more details, please visit our website.

Data Privacy

Genmab is committed to protecting your personal data and privacy. For more information on how we handle your data during the application process, please refer to our Job Applicant Privacy Notice.

Note: In the Netherlands, Genmab's policy for all permanent budgeted hires is to initially offer a fixed-term contract for one year. If performance is satisfactory and business conditions remain stable, a renewal for an indefinite term may be considered.

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