[Hiring] Senior Medical Director - Clinical Research @Pharming Group N.V.
Role Description
The Senior Medical Director is 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 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.
• Participate and provide 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
• Must hold a medical license in good standing in a U.S. State or Territory.
• 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.
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.
• 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.
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The Senior Medical Director is 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 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.
• Participate and provide 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
• Must hold a medical license in good standing in a U.S. State or Territory.
• 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.
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.
• 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.
Apply tot his job
Apply To this Job