Director, Clinical Research Scientist

Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

PhD, Pharm D, MS or equivalent degree in medical, biological, pharmaceutical science or related discipline., Minimum of 10+ years of experience in clinical research, with at least 6 years in drug development, preferably in oncology/hematology., Significant experience in a project-oriented matrixed team environment and leading teams., Proven performance in a comparable role..

Key responsabilities:

  • Lead one or more clinical trials and oversee all aspects of clinical development.
  • Contribute to the development of program strategy and clinical development plans for assigned trials.
  • Author and review clinical and regulatory documents to support registration and commercialization of compounds.
  • Prepare and participate in internal/external committee meetings and provide scientific leadership for Clinical Research.

Genmab logo
Genmab Large http://www.genmab.com
1001 - 5000 Employees
See all jobs

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!


Job Description

Director, Clinical Research Scientist

Serve as a key role in contributing to the scientific and medical expertise in a therapeutic area leading one or more clinical trials for one or more compounds in various stages of clinical development(including clinical trial and program implementation, and oversight of all aspects of clinical development) working closely with the Medical Director/Medical Compound Lead and cross-functionally to effectively implement the global development strategy.

  • Oversee program and the management of Clinical Research Scientists
  • Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
  • Author components, and review clinical and regulatory documents and registration dossiers (i.e., protocol, ICF, IB, safety updates, study reports, regulatory submissions, etc.) to support registration and commercialization of the compound(s)
  • Participate in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key 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
  • Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction
  • Prepare, coordinate and/or participate in internal/external committee meetings including presentation preparation (i.e., Dose Escalation, DMC, Safety, Steering Committee)
  • Participate in the development and review of study plans and serve as a liaison to project teams and CROs
  • Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted
  • Provide input for development of publications in coordination with Scientific Communications
  •  Provides scientific and clinical leadership for Clinical Research



Requirements
 

  • PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
  • Minimum requirement: 10+ years of experience in clinical research with at least 6 or more years of drug development experience (including experience in oncology/hematology drug
    development)
  • Significant experience working in a project-oriented matrixed team environment
  • Experience in leading teams and activities
  • Proven performance in earlier role/comparable role

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

$182,000.00---$273,000.00

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 bonuses. 

Regular full-time U.S. employees are eligible to enroll in Genmab benefits. Our benefits package is crafted to help employees feel supported and cared for in all aspects of life — physical, financial, social, and emotional. 
 

About You

  • You are genuinely passionate about our purpose

  • You bring precision and excellence to all that you do

  • You believe in our rooted-in-science approach to problem-solving

  • You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

  • You take pride in enabling the best work of others on the team

  • You can grapple with the unknown and be innovative

  • You have experience working in a fast-growing, dynamic company (or a strong desire to)

  • You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

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.

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Leadership
  • Distributed Team Management
  • Collaboration
  • Adaptability
  • Problem Solving

Related jobs