Senior Director, Medical Affairs

About Pharming

PharmingHealthcare Inc.is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, witha significant proportionof its employees based in the U.S.

Our Vision

Our Vision is to develop a leading global rare disease company with a diverse portfolio and presence in large markets,leveragingproven and efficient clinical development, supply chain, and commercial infrastructure.

Life at Pharming

Today,more than ever,we'repositioned to realize our vision of becoming a leading global rare disease company. Our success will come from everyone's commitment to our patients, our ability to work with focus and clarity, and our shared dedication to building something meaningful together. We can only achieve this by embracing our biotech culture, Life at Pharming, which is dynamic, experimental, and shaped by what we learn together.

Summary

Reporting to the Vice President, Medical Afffairs-US & Canada, the Senior Director, Medical Affairs role is a leadership position responsible for developing and driving the Medical Affairs Plan for KL1333 for the treatment of primary mitochondrial disease (PMD). The key functions of this role will be to represent and consider the healthcare environment of the US with internal departments including Medical Affairs, Clinical Research, Marketing, Sales, Market Access, Patient Advocacy, & Government Affairs, and external customers involved in PMD research and patient treatment. The Senior Director, Medical Affairs will be a key member of the life cycle team.

Responsibilities

• Ability to demonstrate deep subject matter expertise in PMD/neurology clinical trials and clinical use, pipeline, and competitive products.
• Develop strategies and implementation plans to define and address unmet research and medical needs within the US patient populations affected.




• US customer segments, including traditional Opinion Leaders and HCPs and will include Integrated Medical Systems / Hospitals and Formulary Decision Makers




• Prepare presentation materials and present scientific data at internal meetings and external advisory boards.
• Serve as an information resource and trainer to Pharming colleagues, including medical educational activities, grants and investigator-sponsored/collaborative studies.
• Support data generation activities through:




• Critical review of phase 3b and phase 4 study proposals and Investigator-Initiated Trials (IITs)
• Review of abstracts and/or manuscripts
• Communication of Pharming's commitment to scientific excellence through research and education




• Provide medical and scientific leadership and support at key scientific meetings (US and International)
• Provide strategic input to Global/Regional Medical Affairs Plan and Life Cycle Team activities

• Assist medical and scientific review of US promotional materials for submission to promotional review committee (PRC), medical review committee (MRC), and social medial governance council (SMGC).
• Other activities, as assigned, to support rare disease Medical Affairs initiatives

Qualifications

• Advanced degree in a healthcare field from an accredited university; MD or MD/PhD required
• 8+ years' experience in practice and/or industry, with experience specific to neurology/movement disorders/rare disease/genetic diseases preferred
• Industry experience in Medical Affairs, Clinical Development, or Research or success in a similar role outside of the biotech/pharmaceutical industry preferred
• Strong leadership and management skills
• Experience in product launch, regulatory filings and FDA communications
• Experience successfully managing multiple projects concurrently
• Cultivates and maintains key relationships with both internal and external customers
• Strong presentation and communication skills to both professional and non-professional audiences; able to provide succinct, strategic, and actionable insights to senior leadership and executives
• Proactive self-starter who can lead workstreams independently
• Ability to efficiently work remotely, and travel both domestically and internationally up to 30% of the time
• Commitment and alignment to Pharming's mission, core values and behaviors

Salary Range

Pharming takes into consideration a combination of candidate's work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level.

The base salary range for this job is from $230,000-$330,000 per year.

Compensation & Benefits

• A fully remote work schedule
• Competitive compensation package including annual target bonus
• Long-term incentive program
• 401(k) plan with company match
• Paid Time Off (PTO)
• 13 Company Holidays per year

Other Benefits

• Excellent benefit plans including medical, dental, and vision
• Flexible spending accounts
• Company-provided life insurance, short-term disability, and long-term disability plans
• Optional accident, hospital indemnity, critical illness, and pet insurance plans
• Tuition reimbursement program
• Health and wellness program
• Choice of company provided mobile phone or cell phone stipend

Additional Information

Pharming Healthcare, Inc. is a merit-based equal opportunity employer. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected classes.

An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to HR-US@pharming.com.

Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.