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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 hematologyor 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,...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity