Vice President, Clinical Development

Role Description

Reporting to the Chief Medical Officer, the VP, Head of Clinical Development serves as the medical lead and subject matter expert in key therapeutic areas. The VP is responsible for driving and implementing the clinical development strategy for molgramostim nebulizer solution. The VP plays a central role in clinical trial safety oversight and provides medical/scientific input to cross-functional teams, and will be involved with medical affairs and regulatory to ensure appropriate information availability. This role is involved in the production of clinical study reports and NDA/BLA clinical and safety modules all while developing strong collaborations with clinical investigators and medical thought leaders in the pulmonary therapeutic area.

Core Responsibilities

• Ensure an effective and high-performing clinical development function, including sufficient resources to meet the demands of the company.
• Oversee the Company's clinical development activities, including clinical trial design, implementation, conduct and reporting, safety surveillance and reporting, identification,selectionand oversight of relevant clinical vendors.
• Provide input into clinical development plans and clinical trial protocols, including review of key trial-related documents, procedures, and analysis plans includinginformed consent forms, clinical research forms, statistical analysis plans, and clinical study reports.
• Overseereviewof SAEreports with respect to medical accuracy, causality assessment, and expectation assessment.
• Function as(or provide oversight for) themedical monitor for selected studies, including medical oversight, pharmacovigilance review of medical accuracy, causality, and expectedness, and align scientific aspects of clinical development projects with expert advice and available clinical evidence.
• Collaborate with senior leaders to review and evaluate business development opportunities.
• In collaboration with Quality Assurance, oversee the creation, periodicupdatesandimplementation of excellent clinical development procedures.
• Serve as the primary liaison with Clinical Operations to ensuretimelydelivery of milestones and data.
• Ensure cohesion with Medical Affairs and provide clinical support for publications, advisory boards, and presentations of results at medical congresses.
• Prepare or review documents for regulatory submissions, including clinicalstudyreports, clinical & safety summaries and overviews, and Investigator's Brochures.
• Support business development activities by providing clinical input, technicalexpertise, and medical evaluation of new indications and business opportunities. Generate development plans and medical rationales for new products or indications.
• Keep apprised of medical and scientific knowledge within the assigned clinical area through literature review, participation in scientific meetings, and frequent interactions with clinical experts.
• Maintain and expand the global clinical network with medical/scientific experts and key opinion leaders in the field
• Hire, provide feeback, monitor and direct work, manage performance, and proactively coach direct reports
• Other duties andprojects asassigned.

Qualifications

• Doctorate degree (MD, DO) with10 pharmaceutical/biotechnology/clinical development experience, preferably in PulmonaryMedicine.
• Board certification in pulmonary medicinedesirable.
• Ability to understand and effectively communicate scientific and medical information.
• Proven leadership skills
• Excellent written and oral communication skills are imperative. Ability toanticipateand adapt to change; strong interpersonal skillscommensuratewith the need to work closely with partners, investigators, contractors, consultants, and team members across functions
• Ability to communicate well with health care professionals. Ability toestablishstrong relationships with peer groups, professional organizations, and other outside parties

Work Location and Travel

This role is US-based and requires the ability to work a US Eastern Time Zone. While US-based remote candidates will be accepted, preference is given to candidates within the greater Philadelphia area. Travel to Savara's US HQ outside of Philadelphia is required; other domestic or international travel may also be required (estimated quarterly).

Compensation and Benefits

Savara's approach is to provide comprehensive compensation and benefits that are competitive wtihin the job market, offer opportunities to recognize excellence in performance, and are equitable and accessible for all staff. The base range for this role is $340,000 to $390,000 annually, and the compensation package will include a bonus and equity.

Savara provides comprehensive benefits including:

• Medical, dental and vision coverage
• FSA for health care and dependent care
• Paid time off and paid holidays, including a week-long winter shutdown
• Paid parental leave
• 401(k) with highly competitive match
• Life, AD&D, STD and LTD insurance coverage

About Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.