Senior Clinical Research Scientist

University of Georgia- FACS; Princeton (NJ); Hybrid; USD 144,000 - 216,000; Full time

Benefits offered by this job

401(k) match

Health benefits

Voluntary insurance plans

Paid time off

Parental leave

Backup care

Financial wellness tools

Lifestyle Spending Account

Commuter benefits

Tuition reimbursement

Job summary

Genmab is seeking a Senior Clinical Research Scientist to join the Medical department in Princeton, NJ. You will lead or co-lead clinical trials, develop CDP, and prepare regulatory documents in collaboration with the Medical Director and cross-functional teams.

Ideal candidates hold a PhD, PharmD, MS or equivalent and have at least 6 years in clinical research with 3+ years in drug development, preferably in oncology/hematology. Hybrid work arrangement and competitive compensation offered.

Qualifications

• Minimum of 6 years of experience in clinical research with at least 3+ years of drug development experience.
• Oncology/hematology drug development experience is a plus.
• Proven skills in working in a project-oriented matrixed team environment.
• Excellent oral, written and interpersonal communication skills.

Responsibilities

• Lead or co-lead one or more clinical trial(s) in a therapeutic area for one or more compounds.
• Collaborate with the Medical Director and senior scientists to develop the clinical development plan (CDP).
• Contribute to regulatory documents, safety updates, and regulatory submissions to support registration and commercialization.
• Contribute to data management deliverables and eCRF development and guidelines.
• Develop the medical data review plan and summarize efficacy/safety data for interpretation.

Skills

Clinical research

Drug development

Oncology/hematology

Communication skills

Travel ability

Education

PhD, Pharm D, MS or equivalent degree

Job description

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

As a Senior Clinical Research Scientist, you will be in the Medical department and responsible to contribute to the implementation of the global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development. This may include clinical trial implementation, and oversight of all aspects of clinical development working closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables. You will report to Director, Clinical Research Scientist.

Responsibilities

• Lead or co-lead one or more clinical trial(s) in a therapeutic area for one or more compounds
• Works closely with Medical Director and other Sr. level Clinical Research Scientist (as warranted)
• Contributes to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
• In collaboration with the Medical Director, contributes to the development of clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] to support registration and commercialization of the compound(s)
• Participates in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities).
• Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
• Contributes medical input for country/site selection, feasibility assessment and engage in KOL interaction
• Prepare charters and coordinate internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, and Safety Committees)
• Participate in the development and review of study plans and serve as a liaison to project teams and CROs
• Provide input for the development of publications in coordination with Scientific Communications
• Contribute to training at Investigator meetings, CRO/CRA training, SIVs as warranted

Qualifications

• PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
• Minimum of 6 years of experience in clinical research with at least 3 or more years of drug development experience
• Prior oncology/hematology drug development experience is a plus
• Proven skills from working in a project oriented matrixed team environment
• Excellent oral, written and interpersonal (communication) skills
• Ability to travel, as needed

This role is located in Princeton NJ and is hybrid.

For US based candidates, the proposed salary band for this position is as follows:

$144,160.00---$216,240.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.