Hele denne side er en annonce i samarbejde med Nortra Online.

(Associate) Medical Director

  • Genmab
  • 1000København K,Danmark
  • 04/01/2023
Fuldtid

Jobbeskrivelse

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role We are looking for an experienced and dedicated (Associate) Medical Director to be a part of our Global Clinical Development Team (Hematology). AS (Associate) Medical Director will be accountable for the medical oversight of one or more clinical trials, medical review and communication of data, and medical input into regulatory documents and presentations. This is a full time position that can be located either in Utrecht, NL or Copenhagen DK. Responsibilities: Directing study design, protocol development and execution of clinical research for pivotal cancer studies. Contributing to the overall medical strategy of the assigned clinical development programs and product pipeline as well as giving in-depth medical advice on potential new projects (internal and external). Generating/reviewing clinical components of key documents (regulatory documents, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting registration, market access and commercialization of the compound(s). Ensuring quality of all clinical documents (e.g. Investigators’ Brochure, protocols, study reports, clinical components of regulatory submissions, safety related documents). Also, the Employee shall act as medical expert and have the ability to lead interactions with external stakeholders (e.g. regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups) internal stakeholders (e.g. Research, Translation Medicine, Safety, Regulatory, Global Medical Affairs and Commercial) and internal decision boards. Moreover, the Employee shall: Oversee the safety aspects of patients in clinical studies and signal detection with support of the Safety physician. Plan and execute publication and clinical communication strategy in coordination with Scientific Communications. Provide input to key external presentations. Ensure career development of functional reports (esp. clinical research scientists) and other CMT colleagues through active participation in the performance management and talent planning processes. Provide on-boarding, training and mentoring support and contribute to the performance evaluation of CMT members as appropriate. The Employee shall also render such other related services and duties as may be assigned from time to time by supervisor. Participate in interviews of new potential hires for the Medical Department. Act as the Study Lead and, when needed, represent the program or disease area. Be proactive in interacting with the different line functions to ensure alignment with the objectives of the Medical Department. Requirements Medical Degree is required, background ideally with a minimum of 1+ years of directly related industry in clinical development or academic experience within oncology and/or hematology. Experience as a responsible Medical Officer for clinical trial(s) from industry is required for Director Level. We are open to more junior profiles for Associate Director level and do not require industrial experience for that. Scientific background and/or deep understanding of lymphoma strongly preferred. Ability to represent the Company in a variety of internal and external settings. Persuasive and effective in personal interactions at all levels of the organization. Demonstrated success in teamwork within a matrix organization and ability to inspire trust among colleagues. Innovative, flexible, resilient and visionary with the ability to seize opportunities. Ability to prioritize, respond to directives, and work in a fast-paced and changing environment. Result and goal-oriented and committed to contributing to the overall success of Genmab. Deep desire to make a difference. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer. At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do. 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. Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location 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. Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website https://www.genmab.com/privacy. Scam alert Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation. This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.