Job Description
Job Description
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 Corporation.
Join us, and let’s transform lives, together.
PharmaEssentia USA 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 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 Taiwan Stock Exchange (TWSE : 6446) and are expanding our global presence with operations in the U.
S., Japan, South Korea, and China, along with a world-class biologics production facility in Taichung.
Position Overview :
The Head of Medical is a key member of the executive team, engaged in defining the overall business strategy and direction of the organization.
This position leads the overall Medical function including Medical Affairs, MSL team, Medical Regulatory Affairs, Medical Operations, Safety and Pharmacovigilance, and Patient Advocacy.
The Head of Medical will set the vision for the medical organization and has direct oversight of the group.
Responsibilities :
- Lead and shape clinical strategy, including scientific rationale, regulatory input, and advice from medical KOLs, patient advocacy groups and payors.
- Lead the overall development and execution of Medical Affairs strategy to ensure a robust medical engagement strategy with leading physicians, KOLs, thought leaders and key people at public health organizations.
- Forge and bolster relationships with KOLs and investigators in the MPN space and bring their voices into PharmaEssentia’s clinical programs.
- Oversee medical monitoring and overall pharmacovigilance activities for the company.
- Contribute to the regulatory strategy, preparation, and review of regulatory submissions, and participate in regulatory agency meetings as relevant.
- Contribute to the development of publication plans and present clinical data at key meetings.
- Strong hands-on leadership skills with ability to work on both strategic and operational level of clinical and medical functions.
- Effective communication skills, professional presence, and ability to engage effectively with stakeholders at all levels including the CEO, Board of Directors, General Manager USA, company employees and the investor, medical and patient community.
- Collaborative and able to motivate and energize cross functional team members to achieve shared goals.
Qualifications :
- MD required with 15+ years of experience in Clinical Development and Medical Affairs.
- Hematology, Oncology, and rare disease experience with strong preference for hematology experience.
- Proven ability to oversee clinical and medical functions.
- Understanding of global regulatory requirements and ability to influence decision making experience in late stage interactions (including successful NDAs / BLAs) with regulators preferred.
- Record of designing and leading rigorous clinical development plans in oncology.
- Established links with the medical community globally and locally, with proven ability to develop close working relationships with KOLs.
Benefits of working with our team :
PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits :
- Comprehensive medical coverage : 80% employer paid
- Dental coverage : 90% employer paid
- Vision coverage : 100% employer paid
- 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
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.
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.
https : / / us.pharmaessentia.com / careers /
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