Senior Director, Medical Affairs - PharmaEssentia : Job Details

PharmaEssentia USA is seeking a Senior Director, Medical Affairs to 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 with external KOLs and decision-makers.

The Company PharmaEssentia USA Corporation is a rapidly growing biopharmaceutical innovator. We leverage deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in hematology and oncology, with one product approved in Europe and a diversifying pipeline. We believe in the potential to improve health and quality of life for patients with limited options today through rigorous research and innovative thinking. Founded in 2003, PharmaEssentia USA is expanding its global presence with operations in the U.S., Japan, and China, along with a world-class biologics production facility in Taichung.

• Lead the PharmaEssentia platform and product portfolio specific Medical Affairs strategy and execution
• Develop, execute and collaborate a highly efficient, integrated US medical affairs/scientific strategy
• Provide 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 strategy
• Scientific evidence generation (RWE, HEOR, Phase IV and IIT) and scientific information exchange with all key stakeholders
• Involvement in the planning, strategy, tactics, slide deck development, and training of the MSL team. Strong collaboration with the MSL director
• Provide cross-functional support to MSLs, medical information, regulatory affairs and clinical development with medical and scientific expertise for life cycle management
• Provide relevant data evidence to ensure that the strategy is clearly defined and consistent with clinical development and commercial strategic objectives
• Review and approve medical and scientific content of Regulatory, Safety, Medical Affairs, and Commercial
• Partner with stakeholders to develop and implement real world evidence generating strategies for assigned programs and provide subject matter expertise
• Strategic Guidance / US PEC representation at corporate meetings & events
• Launch Lead/MSL Lead
• External Expert Engagement (Providers, Payers, Advocacy)
• Support Clinical Development
• Support identification and management of and build relationships with key stakeholders
• Identify and review potential clinical study sites supporting Clinical Development in study-site engagement

Education: PhD or PharmD required; MD degree preferred

• Minimum of 10 years of relevant working experience in the Pharmaceutical/Bi Biotechnology industry
• Minimum of 6 years of experience in Medical Affairs
• Ability to articulate complex scientific and medical information in understandable business terms
• Knowledgeable in regulatory guidelines and clinical terminology
• Ability to work independently and with a team with strong writing, communication, and project management skills
• Thorough understanding of clinical methodologies and providing sound analytical support; you quickly establish credibility as a reliable resource
• Experience developing engagement and education tools
• Clinical trial support experience
• Travel required - up to 25%

Preferred Requirements: Experience in hematology/oncology and rare diseases

• Comprehensive medical coverage
• Dental and vision coverage
• Generous paid time-off
• 401(k) retirement plan with competitive company match
• Medical & Dependent Care Flexible Spending Account
• Up to $150 monthly cell phone reimbursement
• Employee Assistance Program
• Free parking

At 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, military and veteran status, and any other characteristic protected by applicable law. Diversity and inclusion are critical to our success as a global company. 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. You will contribute to expanding options for people with cancer by joining our team.

Seniority level: Director

Employment type: Full-time

Job function: Health Care Provider