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At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role:
The Senior Medical Director supports Oncology Clinical Devlopment.
Responsibilities:
- Oversee clinical program including component studies
- Oversee safety of the drug, including the safety aspects of patients in clinical studies and signal detection with support of the Safety physician
- Lead and oversee creation of clinical components of key documents (regulatory documents, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting registration, market access, and commercialization of the compound(s)
- Create, integrate, and execute overall medical strategy of assigned clinical development programs and product pipeline; provide strategic medical advice on potential new projects (internal & external)
- Plan and execute publication and clinical communication strategy in coordination with Scientific Communications; provide inputs to key external presentations
- Direct study design, protocol development, and execution of clinical research for pivotal cancer studies
- Provide medical expertise in oncology, including relevant, up-to-date knowledge of competitor products
- Contribute in an active and ongoing manner to the scientific, medical, and commercial development of current and future product candidates (internally and externally developed)
- Interact with key opinion leaders to ensure implementation of the latest clinical and medical thinking and guidelines into clinical development plans, as well as consideration of novel medical methods development and new potential targets
- Support business development and alliance management activities as needed, including due diligence activities, investor activities, medical input into the assessment of candidate in-licensing products, and ensuring optimal collaboration with partners
- Oversee conception and execution of clinical strategy for specified projects
- Contribute to medical department best practices, standardization and to cross-functional process improvements
- Support the development of case report forms, perform medical monitoring, liaise with investigators and site personnel, perform preliminary and exploratory data analyses on clinical trials, author clinical study reports, provide input on publication materials, and participate in advisory boards.
- Establish productive, interactive relationships with relevant internal departments, as well as the medical and scientific community
- Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
- Create medical deliverables: clinical development plans, concept sheets, briefing books, and label and marketing application dossier
- Contribute and coordinate medical input to preclinical development of candidate therapeutic antibodies
- Participate in selection of the right product candidates for clinical development, etc.
- Drive and monitor quality of all clinical documents (e.g., Investigators’ Brochures, protocols, study reports, clinical components of regulatory submissions, safety documents) produced by CDT
- Act as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, KOLs, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Safety, Regulatory, Medical Affairs, Commercial), and internal decision boards
- Attend relevant congresses or other relevant fora to maintain up-to-date scientific/medical knowledge
Requirements:
- MD background with a minimum of 10+ years of directly related industry experience within oncology or hematology or 10+ years of highly relevant academic experience (e.g. KOL) within oncology or hematology
- Significant experience with relevant areas of oncology
- Proven ability to build and lead teams and inspire trust among colleagues
- Significant experience in building internal/external networks and reputation, and speaking at external forums/conferences as an emerging leader in field
- Experience implementing significant optimization/innovation of organizational processes
- Experience training and managing team members
- Proven performance in earlier role/comparable role
For US based candidates, the proposed salary band for this position is as follows:
At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role:
The Senior Medical Director supports Oncology Clinical Devlopment.
Responsibilities:
- Oversee clinical program including component studies
- Oversee safety of the drug, including the safety aspects of patients in clinical studies and signal detection with support of the Safety physician
- Lead and oversee creation of clinical components of key documents (regulatory documents, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting registration, market access, and commercialization of the compound(s)
- Create, integrate, and execute overall medical strategy of assigned clinical development programs and product pipeline; provide strategic medical advice on potential new projects (internal & external)
- Plan and execute publication and clinical communication strategy in coordination with Scientific Communications; provide inputs to key external presentations
- Direct study design, protocol development, and execution of clinical research for pivotal cancer studies
- Provide medical expertise in oncology, including relevant, up-to-date knowledge of competitor products
- Contribute in an active and ongoing manner to the scientific, medical, and commercial development of current and future product candidates (internally and externally developed)
- Interact with key opinion leaders to ensure implementation of the latest clinical and medical thinking and guidelines into clinical development plans, as well as consideration of novel medical methods development and new potential targets
- Support business development and alliance management activities as needed, including due diligence activities, investor activities, medical input into the assessment of candidate in-licensing products, and ensuring optimal collaboration with partners
- Oversee conception and execution of clinical strategy for specified projects
- Contribute to medical department best practices, standardization and to cross-functional process improvements
- Support the development of case report forms, perform medical monitoring, liaise with investigators and site personnel, perform preliminary and exploratory data analyses on clinical trials, author clinical study reports, provide input on publication materials, and participate in advisory boards.
- Establish productive, interactive relationships with relevant internal departments, as well as the medical and scientific community
- Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
- Create medical deliverables: clinical development plans, concept sheets, briefing books, and label and marketing application dossier
- Contribute and coordinate medical input to preclinical development of candidate therapeutic antibodies
- Participate in selection of the right product candidates for clinical development, etc.
- Drive and monitor quality of all clinical documents (e.g., Investigators’ Brochures, protocols, study reports, clinical components of regulatory submissions, safety documents) produced by CDT
- Act as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, KOLs, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Safety, Regulatory, Medical Affairs, Commercial), and internal decision boards
- Attend relevant congresses or other relevant fora to maintain up-to-date scientific/medical knowledge
Requirements:
- MD background with a minimum of 10+ years of directly related industry experience within oncology or hematology or 10+ years of highly relevant academic experience (e.g. KOL) within oncology or hematology
- Significant experience with relevant areas of oncology
- Proven ability to build and lead teams and inspire trust among colleagues
- Significant experience in building internal/external networks and reputation, and speaking at external forums/conferences as an emerging leader in field
- Experience implementing significant optimization/innovation of organizational processes
- Experience training and managing team members
- Proven performance in earlier role/comparable role
For US based candidates, the proposed salary band for this position is as follows:
$255,000.00---$425,000.00
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.
About You
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed 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 guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website .
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 https://www.genmab.com/privacy .
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.
About Us
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
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