Senior Director, Rare Disease Program Leader

Proclinical is currently recruiting for a Senior Director of Rare Disease Program Leader for a biotechnology company located in Cambridge, MA. Successful candidate will be responsible for leadership and management of the clinical-stage Rare Disease programs from IND to licensure. We are seeking a motivated and energetic Program Leader for multiple rare disease programs to drive the program strategy and maintain accountability of program execution. The successful candidate will work in close coordination with the program manager to enable the execution of the set timelines. The program leader will lead a cross-functional team across clinical operations, regulatory affairs, clinical pharmacology, biomarkers, CMC, non-clinical, and medical to deliver against the program strategy. The successful candidate will have experience in late-stage readiness and development of rare disease programs.

Job Responsibilities

• Lead the cross-functional teams for MMA and PA rare disease programs
• Represent the program status, scenarios, and trade-offs for MMA and PA with senior leadership, internal stakeholders, and external stakeholders
• Align on a program direction in coordination with senior functional leaders and program representatives
• Support development of regulatory documents and HA interactions
• Engage external stakeholders including KOLs and key PIs; engage advisory boards in order to develop an effective program strategy
• Accountable for the integrated development plan for MMA and PA programs
• Develop a program budget in coordination with the program manager, finance and functional representatives; identify trade-offs
• Work with senior leadership to support late-stage development activities including endpoints for registration, patient reported outcomes, and health-economics
• Work with corporate affairs to continue patient advocacy efforts for both MMA and PA

Skills and Requirements:

• BS/MS degree in a scientific field with 15+ years of experience or PhD or MD with 10-12 years of experience in a biotechnology or pharmaceutical setting
• Experience in rare disease drug development including the transition of novel candidates from discovery through licensure
• Proven track record of successful cross functional program leadership or management supporting early- and late-stage programs
• Strong ability to lead cross-functional teams; engage senior leadership, health authorities, and KOLs
• Prior experience managing or working within cross-functional project teams with timeline management and budgetary responsibility
• Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally
• Strong written and oral communication skills as well as demonstrated organizational aptitude

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Max Robinson at (+1) 929-388-1651 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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