VP Medical Affairs
Medical Affairs | Waltham, MA | Full Time
Oncopeptides is a global biotech company committed to developing targeted therapies for patients facing hard-to-treat hematological diseases. Oncopeptides has one U.S. FDA approved product, PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen. PEPAXTO is approved for patients with triple-class refractory multiple myeloma and was evaluated in several clinical studies including the pivotal Phase 2 HORIZON study and is currently being evaluated in the confirmatory Phase 3 OCEAN study. Oncopeptides’ headquarters is in Stockholm, Sweden, with a U.S. headquarters in Boston, Massachusetts. In addition to Boston, Oncopeptides has a footprint in Los Altos, California, another U.S. biotech hub. PEPAXTO®is a trademark of Oncopeptides AB (publ).
The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.
The company is in a strong financial position and has an effective Executive Team and Board of Directors. Discover more about Oncopeptides at www.oncopeptides.com
The VP Medical Affairs US is the formal leader of the US Medical Affairs organization and the line manager of part of the medical affairs US organization. The VP Medical Affairs US needs to have the ability to lead and collaborate in a cross-functional setting. General management skills, strategic thinking, excellent scientific and medical understanding within the field of hematology/oncology as well as proven ability to work with key external stakeholders is essential to the role. The VP Medical Affairs US always acts with a scientific and patient centric mindset.
The VP Medical Affairs US reports to the SVP and Global Head of Medical Affairs. Furthermore, has a dotted line into the General Manager, ONCOPEPTIDES US. The VP Medical Affairs US must not have commercial objectives or measures and must comply with all applicable rules, regulations and standards.
· Lead, manage and develop the US Medical Affairs team including direct line management of Medical Affairs team members such as Medical Affairs Director, Evidence Generation Director, Regional MSL Managers, Nurse Educator Manager, Patient Advocacy Lead, Project manager, and Medical Assistant.
· Ensure an agile and innovative Medical Affairs organization that is externally focused.
· Develop and execute the Medical Affairs plan for Oncopeptides US, fully aligned with the Global Medical Affairs strategy.
· Oversee all medical activities in US that are needed to support data generation in line with the R&D strategy, Translational Research plan and Medical Affairs Evidence Generation plan. Includes Global activities performed in the country as well as country-specific projects.
· Contribute to the development and implementation of the Global Investigator Initiated Trial (IIT) strategy. Review, assessment and prioritization of US proposals in line with the Global IIT strategy. Ensure execution of approved proposal in line with all applicable rules and regulations.
· Build and maintain critical relationships in the medical and scientific communities including US Key Opinion Leaders (KOLs) and key decision makers in US medical centers.
· Engage with US disease-specific non-governmental organizations as per need.
· Ensure qualitative and sufficient medical contribution to gain market access across US at national and regional levels.
· Provide medical expertise as per need to Oncopeptides regulatory group and as per need participate in meetings with regulators and applicable authorities.
· Review and approve any promotional/educational information materials for medical accuracy as per local rules and regulations and in line with Oncopeptides SOPs.
· Interact closely with the US commercial group by providing medical input to the commercial strategy, ensure training and support to the commercial organization related to clinical aspects of the disease area of interest and ensure high quality scientific and core message integrity.
· Represent Medical US in the Global Medical Affairs Leadership team, the US leadership team as well as any other cross-functional US and Global teams as per need.
· The US Director of Medical Affairs has an overarching responsibility for the US Medical Affairs budget.
· Study physician for Early Access Program and other Medical Affairs initiated studies as per need.
· Medical Doctor
· 10 + years pharma experience including Oncology or Hematology and with at least 5 years of experience from Medical Affairs. The candidate must have been involved in preparing and execution of at least one successful launch.
· Experience in KOL advocacy development and highly credible with existing MM networks among top KOLs. Skills in establishing long lasting relationships with different working groups, societies and other stakeholders.
· Demonstrated capabilities in development of medical strategies, tactics and proven track record of impactful execution of Medical Affairs activity plans in pre-launch and launch phase.
· Good understanding of data generation including RWE, Clinical trials, IITs, Translational research.
· Extensive experience from leading and managing people with a track record of building high performing teams.
· Demonstrated ability to lead and act in international, highly multicultural environment.
· Solid collaboration and teamwork inter-personal characteristics.
· Innovative mindset with the ability to work in an agile environment.
· Pro-active and goal oriented with the ability to act independent
· Always keep high ethical standards and acting compliant to applicable rules and regulations.
· Current GCP Training