Senior Director, US Regulatory Policy Lead
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
The Senior Director, US Regulatory Policy, reports directly to the US Regulatory Intelligence & Policy Lead for BeiGene. The incumbent will be expected to establish and maintain strong interfaces with FDA as well as identify, lead, and execute on regulatory policy priorities for BeiGene. The US Regulatory Policy Senior Director will drive value to patients, heath care providers, and BeiGene business by shaping key regulatory policy priorities and by providing expert insights on pipeline and marketed products to ensure that changing regulatory policy landscape in the US are incorporated into BeiGene short-term and long-term regulatory strategies.
Essential Functions of the job:
Proactively lead US Regulatory Policy for BeiGene by continuing to establish and maintain strong interfaces with the FDA Provide expertise, executive briefings and staffing for BeiGene Senior Leaders’ Board level responsibilities (including BeiGene CEO and Executive Committee members) as the FDA regulatory policy representative with select US industry trade associations (e.g. BIO). Establish regulatory policy topic priorities for BeiGene in order to focus policy efforts in the US region and spearhead plans that influence short-term and long-term goals on priority policy topics, including but not limited to expanding diversity in US clinical trials for drug development Demonstrate the keen ability to drive and shape BeiGene policies to help advance our public policy agenda, especially in oncology and rare disease drug development Direct the development of BeiGene company positions in response to draft FDA regulatory policies Effectively represent the BeiGene position and serve as the company representative internally and externally on key policy topics to appropriately shape the regulatory environment with health authorities (e.g. interact with the FDA and engage in proactive policy activities policy topics, such as real world data, rare diseases, pediatrics, diversity in clinical trials) as well as engage with patient advocacy organizations, medical societies and key industry stakeholder such as DIA, BIO, etc. Drive value to external key stakeholders and BeiGene business by shaping key US regulatory policy priorities and providing expert insights on complimentary global policy topics Provide strategic expert insights into regulatory strategies for BeiGene’s marketed and pipeline products to ensure FDA’s policies are understood and requirements are satisfied; effectively communicate FDA’s current thinking to help BeiGene effectively manage regulatory hurdles so that BeiGene can become a value leader in the US market Demonstrate the ability to work effectively in a matrix environment where connectivity is paramount and a priority over reporting lines, including establishing and maintaining strong partnerships with cross-functional groups and departments across the business (e.g. clinical, regulatory, commercial, legal, government affairs, etc.) Establish, build on, and maintain close relationship with Regulatory Intelligence to partner on any clinical / reg background and precedent across products and indications and how / which policies apply and hurdles Demonstrate leadership and further efforts for BeiGene’s culture and core values initiatives
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
Computer Skills: Advanced MS Office skills and additional IT skills as regulatory intelligence function evolves.
- FDA experience (5-10 years)
- Pharmaceutical Industry Regulatory Policy experience (at least 10 years)
- High degree of understanding of medical product regulations, policies, and guidances
- Scientific knowledge: product development expertise
- Preferable advanced degree (at least Masters; BS Pharm, Pharm D, PhD preferred)
- Strong writing, speaking, and presentation skills
- Familiarity with quantitative sciences
- Strong experience in product development
- Critical thinker, able to analyze and critique data
- Intellectually creative
Travel: Health Authority meetings as directed.
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Learn more here
BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, United States and Europe. BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, see www.beigene.com.
Job posted: 2021-03-13