Senior Medical Director - Clinical Research

Senior Medical Director - Clinical Research

About Pharming

Pharming Healthcare 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, with a significant proportion of 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, leveraging proven and efficient clinical development, supply chain, and commercial infrastructure.

Life at Pharming

Today, more than ever, we're positioned 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. We are looking for people who are excited about our vision and living our values:

• We put Patients at the heart

• We act with urgency

• We make it simple

• We get it done

Summary

The Senior Medical Directoris a critical member of the Clinical Research and asset development teams for napazimone.Reporting to the Vice President- Clinical Research and working closely with the Executive Medical Director and Life Cycle Team leader for napazimone, this person will provide strategic medical and scientific leadership for development-stage products with a focus on napazimone for Primary Mitochondrial Disease. The successful candidate will lead/support global clinical research and activities for napazimone and other Pharming products.

Responsibilities

• Lead/support clinical development (strategy, develop protocols, study start-up, close-out, oversight, and regulatory support) for napazimone studies

• Dedicated medical and scientific role to execute of the clinical strategy for the napazimone program, including

• Support the pivotal napazimone studies for mtDNA Primary Mitochondrial Disease

• Lead the napazimone pediatric study plan and clinical pharmacology studies

• Lead the napazimone program for new indications

• Work cross-functionally to define, plan, and implement studies

• Lead the sponsor oversight of medical monitoring across the napazimone programs

• Analyze and oversee data from clinical trials and produce reports, including safety data, efficacy data, completeness and trend analysis eCRF data, and oversight of protocol deviations

• Lead clinical study site engagement in the US

• Participating and providing clinical input into safety and regulatory interactions.

• Participate in strategic planning as part of Medical Affairs, Marketing and Business Development teams

• Provide medical and scientific leadership and support at key scientific meetings (US and International)

• Extensive interactions with academic thought leaders to optimize and develop clinical trial strategies

• Perform other duties as assigned

Qualifications

• Medical license in good standing in a U.S. State or Territory preferred

• 5+ years in clinical development including managing CROs

• Experience in product launch, regulatory filings and FDA communications highly preferred

• Strong leadership and management skills

• Strong verbal and written communication skills are essential

• Exceptional interpersonal skills and problem-solving capabilities

• Ability to work effectively across a global matrixed organization

• Travel - Include 20% travel time required for the position where travel occurs locally or internationally, if applicable

• 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 $310,000 to $375,000 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.