Director, Global Medical Affairs Strategy

Gevonden in: Talent NL C2 - 2 weken geleden

Utrecht, Nederland Genmab Voltijd

The Role

The Genmab pipeline comprises of robust and diverse antibody products in immuno-oncology and beyond. Reporting to the Global Medical Affairs Strategy Lead (MASL) the Director will be responsible for the development and execution of the Global Medical Affairs strategic and tactical plans for the asset(s) for the primary indication as well as new indications to expand into as part of the asset life cycle management. The Director should have a strong background and experience in the field of solid tumors, with proven ability to translate and align commercial and scientific goals and objectives into actions. Director will work as an integral part of the Medical Affairs Strategy Team in close alignment with Global Medical Affairs Strategy Lead and the cross-functional medical affairs cross functional partners, providing input and strategic direction for the program. Director will also support data generation and life cycle management initiatives as well as establish and maintain the relationships with the global thought leaders in support of the programs. 

Responsibilities

  • Lead annual medical planning for asset(s) ; Work closely with extended medical affairs functions (global and regional markets) to inform and implement overall medical strategy for designated products and/or therapeutic areas 
  • Lead and execute on engagement strategy with thought leaders, patient advocacy groups, professional societies and institutions 
  • Lead the planning and execution of Early Access Program,  and investigator initiated trials program, within appropriate standards for compliance, quality, timeliness, and budget.in alignment with MASL 
  • Contribute and execute on the life cycle management of the asset (s)
  • Drive collaboration with cross-functional teams (e.g. commercial, field/regional, medical information/communication, HEOR) to provide support, medical review, and medical expertise advice as required 
  • Collaborate with medical and clinical operations departments to coordinate the planning, execution, and management of clinical trial activities across medical affairs functions  
  • Contribute to effective publication planning to ensure consistent and meaningful scientific communication 
  • Contribute to the development of internal guidance and process/resource documents 
  • Contribute to development and review of regulatory documents for regulatory submissions
  •  Serve as medical reviewer and expert on promotional and medical review committees 
  • Inform development of strategies to demonstrate the value of disease/products with focus on payer and clinical decision-maker outcomes 
  • Lead the strategy team congress activity planning in collaboration with cross-functional stakeholders, and compiling of congress reports including key competitive intelligence 

Requirements

  • Scientific or Medical Degree (Pharm D, PhD, MD) required  
  • Expertise in clinical landscape of solid tumors required; Knowledge of gynecological cancers and/or head & neck cancer is preferred.
  • 7+ years of medical affairs or clinical development background in oncology  
  • Biotech / Pharmaceutical industry experience, with strong understanding of solid tumor drug development and medical affairs function 
  • Ability to work successfully under pressure in a fast-paced environment and with tight timelines 
  • Demonstrated ability to lead strategically, drive performance, build alignment, inform, negotiate, and collaborate across partnerships 
  • Ability to lead collaboratively across various internal stakeholders and develop trusted partnerships 
  • A strong ability to interpret and articulate clinical/HEOR data and the impact on development programs 
  • In depth understanding of compliance and regulatory requirements for pharmaceutical Medical Affairs, R&D and Commercial work 
  • Knowledge of evidence-based medicine concepts, applied biostatistics and health economics are desirable 
  • Demonstrated organizational skills to manage multiple projects simultaneously, prioritize projects effectively and communicate at all levels within the company 
  • Strong written and verbal communication skills (including presentation skills)  
  • Ability to travel internationally to conferences and meetings, which will include occasional weekend travel 

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

$,.00---$,.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.

  • Medical Director

    Gevonden in: Talent NL C2 - 3 weken geleden

    Utrecht, Nederland Genmab Voltijd

    The Role & Department Genmab continues to grow and is currently seeking a Medical Director to join our Medical Solid Tumor Team, focusing on early development/First-in-human trials.As Medical Director at Genmab, you will be accountable for the medical oversight of one or more clinical trials, medical review and communication of data, and medical input into...

  • Senior Director, Regulatory Affairs Strategy-EU/RoW

    Gevonden in: Talent NL C2 - 1 week geleden

    Utrecht, Nederland Genmab Voltijd

    The Role & DepartmentAs a Senior Director, you will join our Global Regulatory Affairs organization. In this capacity, you will assume responsibility for the EU/ROW regulatory strategy for an assigned program and will manage a group of Regulatory Strategists with EU/ROW responsibilities for our programs across all stages of development. The chosen candidate...

  • Regulatory Affairs Specialist

    Gevonden in: Talent NL C2 - 5 dagen geleden

    Utrecht, Nederland Undutchables Voltijd

    Key activities/main objectivesManage and ensure compliance with regulatory requirements for the product portfolio.Provide regulatory affairs (RA) support for research and development Key activities/main objectivesManage and ensure compliance with regulatory requirements for the product portfolio.Provide regulatory affairs (RA) support for research and...

  • Regulatory Affairs Specialist

    Gevonden in: Talent NL A C2 - 3 dagen geleden

    Utrecht, Nederland Undutchables Voltijd

    Key activities/main objectivesManage and ensure compliance with regulatory requirements for the product portfolio.Provide regulatory affairs (RA) support for research and development Key activities/main objectivesManage and ensure compliance with regulatory requirements for the product portfolio.Provide regulatory affairs (RA) support for research and...

  • Regulatory Affairs Specialist

    Gevonden in: beBee S NL - 4 weken geleden

    Utrecht, Nederland Mediq Voltijd

    What are you going to do? Your position as a Regulatory Affairs Specialist is in our Quality Management team where we always have various projects on the agenda. Regulatory affairs for medical devices is a wide area with a wide range of expertise in clinical and in technical aspects. Your main responsibilities consists of: Collecting, registering,...

  • Product development scientist medical devices

    Gevonden in: Talent NL 2A C2 - 3 weken geleden

    Utrecht, Nederland Oxford Global Resources Voltijd

    We are looking for passionate product developer within medical divides.You well work on developing cutting-edge solutions utilizing synthetic bioresorbable materials and therapeutic proteins.Job Description: We are seeking a talented and motivated Product Development Scientist with expertise in medical devices to join our dynamic team.As a Product...

  • Product Development Scientist Medical Devices

    Gevonden in: Whatjobs NL C2 - 4 dagen geleden

    Utrecht, Nederland Oxford Global Resources Voltijd

    We are looking for passionate product developer within medical divides.You well work on developing cutting-edge solutions utilizing synthetic bioresorbable materials and therapeutic proteins. Job Description: We are seeking a talented and motivated Product Development Scientist with expertise in medical devices to join our dynamic team. As a Product...

  • Product Development Scientist Medical Devices

    Gevonden in: Talent NL C2 - 3 dagen geleden

    Utrecht, Nederland Oxford Global Resources Voltijd

    We are looking for passionate product developer within medical divides. You well work on developing cutting-edge solutions utilizing synthetic bioresorbable materials and therapeutic proteins. Job Description: We are seeking a talented and motivated Product Development Scientist with expertise in medical devices to join our dynamic team. As a Product...

  • Product Development Scientist Medical Devices

    Gevonden in: Talent NL A C2 - 1 week geleden

    Utrecht, Nederland Oxford Global Resources Voltijd

    We are looking for passionate product developer within medical divides. You well work on developing cutting-edge solutions utilizing synthetic bioresorbable materials and therapeutic proteins. Job Description: We are seeking a talented and motivated Product Development Scientist with expertise in medical devices to join our dynamic team. As a Product...

  • Product Development Scientist Medical Devices

    Gevonden in: beBee S NL - 3 weken geleden

    Utrecht, Nederland Oxford Global Resources Voltijd

    We are looking for passionate product developer within medical divides. You well work on developing cutting-edge solutions utilizing synthetic bioresorbable materials and therapeutic proteins. Job Description: We are seeking a talented and motivated Product Development Scientist with expertise in medical devices to join our dynamic team. As a Product...

  • Real World Evidence

    Gevonden in: Talent NL C2 - 1 week geleden

    Utrecht, Nederland Lilly Voltijd

    We’re looking for people who are determined to make life better for people around the world. The RWE Scientist (medical affairs) will contribute to the compendium of evidence in support of demonstrating the value of Lilly’s medicines across all business units and mainly focusing on data helping to obtain and keep reimbursement. The development of the...

  • Strategy Consultant FEC

    Gevonden in: beBee S NL - 2 weken geleden

    Utrecht, Nederland Rabobank Voltijd

    Bouw jij mee aan de korte en lange termijn strategie van het Global Financial Economic Crime (FEC) domein? Jij & jouw functie Wil jij impact hebben in het beschermen van onze klanten, de Rabobank en de maatschappij door het bestrijden van financiële en economische criminaliteit? Werk jij graag in een kleinschalig team aan het ontwikkelen en realiseren van...

  • Strategy Consultant FEC

    3 weken geleden

    Utrecht, Nederland Rabobank Voltijd

    Bouw jij mee aan de korte en lange termijn strategie van het Global Financial Economic Crime (FEC) domein? Jij & jouw functie Wil jij impact hebben in het beschermen van onze klanten, de Rabobank en de maatschappij door het bestrijden van financiële en economische criminaliteit? Werk jij graag in een kleinschalig team aan het ontwikkelen en realiseren van...

  • Associate Director, QA GCP/PV

    Gevonden in: Talent NL C2 - 3 weken geleden

    Utrecht, Nederland Genmab Voltijd

    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...

  • (Associate) Director, Global Drug Safety

    Gevonden in: Talent NL C2 - 1 week geleden

    Utrecht, Nederland Genmab Voltijd

    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...

  • Senior Strategy Consultant FEC

    2 weken geleden

    Utrecht, Nederland Rabobank Gruppe Voltijd

    Bouw jij mee aan de korte en lange termijn strategie van het Global Financial Economic Crime (FEC) domein? Jij & jouw functie Wil jij impact hebben in het beschermen van onze klanten, de Rabobank en de maatschappij door het bestrijden van financiële en economische criminaliteit? Werk jij graag in een kleinschalig team aan het ontwikkelen en realiseren van...

  • Associate Director, Laboratory Support

    6 dagen geleden

    Utrecht, Nederland Genmab Voltijd

    The Role Genmab is modernizing the corporate IT function globally to better serve the business and support company growth. Genmab is aiming to become a fully integrated global biotech company, operating in an efficient and compliant manner by providing IT solutions and services that enhance productivity and innovation. To support this strategy going...

  • Applications Director

    3 weken geleden

    Utrecht, Nederland LRM Group Voltijd

    Uitdagende MT positie binnen de ICT afdeling in een internationale context Kenmerken: Uitdagende MT positie binnen de ICT afdeling in een internationale context; Vertalen Business demands naar applicatie- en processtrategie; Doel moet zijn een zo standaard mogelijk ERP en PLM applicatielandschap; Geeft leiding aan 10 professionals en een...

  • Medical Science Liaison Neurology

    Gevonden in: Talent NL C2 - 5 dagen geleden

    Utrecht, Nederland Lilly Voltijd

    We’re looking for people who are determined to make life better for people around the world. #Wearelilly Medical Science Liaison Neurology Position: The Medical Science Liaison is an expert in communicating complex scientific and medical information to various stakeholders. You are the first contact person and clinical data expert for...

  • Medical Science Liaison Manager Belgium

    3 weken geleden

    Utrecht, Nederland Eli Lilly and Company Voltijd

    Medical Science Liaison Manager Belgium & the Netherlands page is loaded Medical Science Liaison Manager Belgium & the Netherlands Apply locations Belgium, Brussels Netherlands, Utrecht time type Full time posted on Posted 30+ Days Ago job requisition id R-57008 At Lilly, we unite caring with discovery to make life better for people around the world. We...