Apply on Employer Site

Savara Inc. · 4 hours ago

Vice President, Clinical Development

United States

Full-time

Remote

Director/Executive

$340K/yr - $390K/yr

10+ years exp

Savara Inc. is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The Vice President, Clinical Development will serve as the medical lead and subject matter expert, responsible for driving the clinical development strategy for molgramostim nebulizer solution and overseeing clinical trial safety oversight.

BiopharmaBiotechnologyPharmaceutical

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, selection and 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 including informed consent forms, clinical research forms, statistical analysis plans, and clinical study reports

Oversee review of SAE reports with respect to medical accuracy, causality assessment, and expectation assessment

Function as (or provide oversight for) the medical 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, periodic updates and implementation of excellent clinical development procedures

Serve as the primary liaison with Clinical Operations to ensure timely delivery 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 clinical study reports, clinical & safety summaries and overviews, and Investigator's Brochures

Support business development activities by providing clinical input, technical expertise, 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 feedback, monitor and direct work, manage performance, and proactively coach direct reports

Other duties and projects as assigned

Qualification

Doctorate degree MDDoctorate degree DOPharmaceutical/biotechnology experienceClinical development experienceBoard certification in pulmonary medicineWrittenLeadership skillsOral communicationInterpersonal skillsRelationship buildingAdaptability

Required

Doctorate degree (MD, DO) with 10+ pharmaceutical/biotechnology/clinical development experience, preferably in Pulmonary Medicine

Ability to understand and effectively communicate scientific and medical information

Proven leadership skills

Excellent written and oral communication skills are imperative

Ability to anticipate and adapt to change; strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions

Ability to communicate well with health care professionals

Ability to establish strong relationships with peer groups, professional organizations, and other outside parties