Senior Director, Medical Affairs

The CompanyIt’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia USA. Join us, and let’s transform lives, together. PharmaEssentia USA Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved in Europe and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taipei Exchange (6446) and are expanding our global presence with operations in the U.S., Japan, and China, along with a world-class biologics production facility in Taichung.Position OverviewThe Senior Director, Medical Affairs role will identify and integrate the unmet needs and perspectives of healthcare providers, payers, patients, and caregivers into product and franchise Medical Affairs strategies. You will be responsible for the strategic development and overall accountability and tactical execution of our flagship product ropeginterferon launch in polycythemia vera. You will collaborate cross-functionally as well as collaborate with external KOLs and decision-makers.Key ResponsibilitiesLead the PharmaEssentia platform and product portfolio specific Medical Affairs strategy and executionDevelop, execute and collaborate a highly efficient, integrated US medical affairs/scientific strategyProvide management and oversight of the Medical Affairs team which includes the US HEOR team, publication and scientific communication team, call center, Congress planning and KOL mapping and strategyScientific evidence generation (RWE, HEOR, Phase IV and IIT) and scientific information exchange with all key stakeholdersInvolvement in the planning, strategy, tactics, slide deck development, and training of the MSL team. Strong collaboration with the MSL directorProvide cross-functional support to MSLs, medical information, regulatory affairs and clinical development with medical and scientific expertise for life cycle managementProvide relevant data evidence to ensure that the strategy is clearly defined and consistent with clinical development and commercial strategic objectivesReview and approve medical and scientific content of Regulatory, Safety, Medical Affairs, and CommercialPartner with stakeholders to develop and implement real world evidence generating strategies for assigned programs and provide subject matter expertiseStrategic Guidance / US PEC representation at corporate meetings & eventsLaunch Lead/MSL LeadExternal Expert Engagement (Providers, Payers, Advocacy)Support Clinical DevelopmentSupport identification and management of and build relationships with key stakeholdersIdentify and review potential clinical study sites supporting Clinical Development in study-site engagementThe PersonEducation: PhD or PharmD required; MD degree preferredQualifications and ExperienceMinimum of 10 years of relevant working experience in the Pharmaceutical/Biotechnology industryMinimum of 6 years of experience in Medical AffairsAbility to articulate complex scientific and medical information in understandable business termsKnowledgeable in regulatory guidelines and clinical terminologyAbility to work independently and with a team with strong writing, communication, and project management skillsThorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resourceExperience developing engagement and education toolsClinical trial support experienceTravel required - up to 25%Preferred RequirementsExperience in hematology/oncology and rare diseasesThe expected salary range for this position based on greater Boston, MA location is $250,000-$290,000. Actual salary pay will be based on multiple factors, including geographic location, experience, qualifications, and other job-related factors permitted by law.BenefitsComprehensive medical coverageDental and vision coverageGenerous paid time-off401(k) retirement plan with competitive company matchMedical & Dependent Care Flexible Spending AccountUp to $150 monthly cell phone reimbursementEmployee Assistance ProgramFree parkingEEO StatementAt PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer. #J-18808-Ljbffr