Sr. Director, Evidence Generation
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
Senior Director Evidence Generation is responsible for identifying evidence gaps for US and address those in line with Oncopeptides strategy, priorities and needs. The Senior Director Evidence Generation serve as the link between the US Medical Affairs team and the Global Medical Affairs and Market Access team working to support US specific Investigator Initiated Trials, Epidemiology, Real World Evidence projects and Health Economics and Outcomes Research projects. The scope includes everything from planning to execution and requires proficiency in pharmaceutical research design and methods, pharmacoeconomic principles, project and vendor management skills. The Senior Director Evidence Generation should have experience from studies including real world data, patient reported outcomes and epidemiologic initiatives that supports the market access and communication strategies throughout the lifecycle of Oncopeptides products.
The Senior Evidence Generation Director US reports to the Head of Medical Affairs US. The Senior Evidence Generation Director US must not have commercial objectives or measures and must comply with all applicable rules, regulations and standards.
This position is based in Waltham, MA.
Essential Duties & Responsibilities:
- Develop a deep understanding of internal and external stakeholders needs by identifying evidence gaps in line with Oncopeptides product strategies.
- Demonstrate a thorough understanding of RWD sources to guide the organization on appropriate data sources to use for addressing key business questions.
- Lead the development of a US medical evidence plan in close cross-functional collaboration and in close alignment with the Global Medical Affairs team.
- Ensure organized and timely execution and completion of projects included in the US Medical evidence plan.
- Coordinate the procurement of various US specific datasets, design and implement analytical solutions in support of various business strategies e.g. understanding of current treatment landscape, burden of disease, unmet need based on RWD sources.
- Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, dossiers, and other means.
- Thoughtful vendor management in line with our needs. Ensuring vendors act in line with all applicable standards, rules, and regulations.
- Monitor the external environment to stay up to date on leading analytic capabilities, both within and outside of pharma, which can be applied within the organization.
- Guide and support the US Medical field team when Investigator Initiated Trial (IIT) proposals are received to ensure proposals of high quality and in line with strategy
- Support the dialogue with Global Medical Affairs team in close collaboration with the field team.
- Serve as a link between US Medical Affairs and Global Medical Affairs in development of evidence strategies and tactics.
- Represent US Medical Affairs in relevant cross-functional teams. Serve as a valued partner to ensure aligned prioritization.
- Responsible for budget development and planning including assessing cost and ensure return of investment. Furthermore, ensure cost control and strategic use of budget related activities within the scope of the role.
- Retrospective and prospective collection of PROs, accountability for adaptation of pharmacoeconomic modelling in close collaboration with the Global HEOR team.
Experience, Education, Training, Traits:
- Medical Doctor or master’s degree in Natural Science
- 10 + years pharma experience including Oncology or Hematology and with at least 5 years of experience from Medical Affairs.
- Demonstrated capabilities in development of medical evidence strategies, tactics, and proven track record of impactful execution of Medical Affairs Evidence plans in pre-launch and launch phase.
- Proficiency in data generation including non-interventional studies and real world evidence studies.
- Good understanding of clinical trial development
- Strong organizational skills and time management; ability to manage diverse range of simultaneous projects.
- Demonstrated ability to act as an informal leader in an international, highly multicultural matrix organization.
- Solid collaboration and teamwork inter-personal characteristics including excellent verbal and written communication skills.
- Innovative mindset with ability to solve for problems through creative thinking.
- Ability to work in an agile fast-moving 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