Director, Clinical Development

Company Overview:

At Avalyn Pharma, we are focused on enhancing the lives of patients with rare respiratory diseases through the development of innovative inhaled therapies. Our lead asset is Phase 2b-ready for the treatment of pulmonary fibrosis.

Position Overview:

Director, Clinical Development, is responsible for ensuring that Avalyn Pharma assets from a clinical development perspective are aligned for success, from early clinical development, leading up to launch. The Director, Clinical Development, does this by bringing together a deep knowledge of the ILD/IPF therapeutic area landscape, US and Global external expert insights, US/Global healthcare dynamics, understanding of the clinical medical environment, and the clinical development experience to translate medical needs and gaps into an integrated strategic clinical development plan that enables the clinical development role in the overall Avalyn Pharma market approach, while informing medical affairs efforts to support this goal. The Director Clinical Development is responsible for active involvement in all clinical development programs initiated by Avalyn Pharma.

Essential activities to be accomplished: clinical trial medical direction, collaborates cross functionally across within the larger Avalyn Pharma functions such as Clinical Operations, Medical Affairs, Field Based Medical, Regulatory Affairs, and externally with vendors filling key roles in the conduct of our trials; creates, executes, measures, and adapts the clinical development strategy, including trial strategy and design; works with Medical Affairs to develop the appropriate communications for FBM, Patient Advocacy and Professional Relations, appropriate publication strategy and plans.

Key Responsibilities:

• Cross collaborates with Sr. VP Clinical Development, VP Clinical Operations, VP Medical Affairs, and Sr. VP, Program Management to co-create the clinical development plan to ensure that market needs are met, including clinical trial design, clinical indication, choice of potential comparator, implementation of imaging and biomarker plan.
• Fulfills the day-to-day medical oversight of clinical trials in all clinical development programs initiated by Avalyn Pharma
• Works collaboratively with Sr. VP Clin Dev, Sr. Director Clin Dev, and CMO to align on best-in-class collaborations with external partners for potential trial outcomes (i.e. imaging, bio bank, lung function, etc.)
• Ensures external experts' and patient’s feedback and input to the overall clinical development plan and specific clinical protocols.
• Implements excellence in clinical development as well as the generation of a consolidated medical strategy and integrated evidence plan to address meaningful gaps internally and externally.
• Oversees, in collaboration with Sr. VP, Clinical Development throughout the lifecycle from early clinical development through approval, launch and loss of exclusivity
• Collaborates with Medical Affairs to promote synergies throughout the product lifecycle to ensure the success of launches and timely execution of prioritized evidence generation initiatives.
• Responsible for providing clinical development insights into the Target Product Profiles, Clinical Development Plans, Pediatric Investigational Plan, core Clinical Trial Protocols, Project Analysis and Data Management Plan, Investigator Brochure, Annual Safety Report / IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development, and input into regulatory strategies and labeling discussions.
• Provides medical input in regulatory meetings and contributes to the submission strategy, regulatory dossiers, and safety issues.
• Contributes to the development of advisory boards, adjudication committees and Safety Data Monitoring boards.
• Collaborates with Medical Affairs to support profile of external experts for Field Based Medicine interaction.

Key requirements for this role are:

• MD/DO, APRN, MS, or PharmD with a strong clinical and research background in ILD, including IPF and PPF. MBA a plus.
• Demonstrated experience in developing and executing clinical trial strategy and plans, tactics to initiate and maintain trial plans, and integrated evidence generation both for the strategic plan and following the study
• Background scientific knowledge of the US/Global healthcare system and regulatory landscape, including the needs of providers, patients, payers, and caregivers
• Ability to translate science into clinical patient value and operate within SOPs and working instructions
• Strong oral and written communication skills as well as the ability to present complex information to large scientific / academic audiences as well as to the media
• Strong understanding of the shifting healthcare environment, medical, pharmaceutical and payor market dynamics, portfolio growth
• Ability to manage multiple projects and identify risks in a fast-paced environment with a drive for results and sense of urgency to meet medical market needs
• Ability to travel as required by the nature of the role including conferences and KOL meetings
• Self-motivated, independent, and able to work effectively in a small team and fast-paced environment
• Strong organizational and time-management skills, with the ability to prioritize and manage multiple projects simultaneously