Senior Director, Medical Affairs

The Company

It’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 Overview

The 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 Responsibilities

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

The Person

Education : PhD or PharmD required; MD degree preferred

Qualifications and Experience

Minimum of 10 years of relevant working experience in the Pharmaceutical / 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

The 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.

Benefits

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

EEO Statement

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 (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.

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