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Director of Clinical Development

Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Overview:

Our 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, will possess a deep knowledge of the ILD/IPF therapeutic area landscape, US and Global external expert insights and 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. The Director, Clinical Development will be responsible for active involvement in all clinical development programs initiated by Avalyn Pharma current and future state.

• The Director, Clinical Development will also be responsible for clinical trial medical direction and will collaborate cross functionally across Avalyn Pharma functions such as Clinical Operations, Medical Affairs, Field Based Medical and Regulatory Affairs. This person will serve as a primary liaison with external vendors filling key roles in the conduct of our trials; creating, executing, measuring, and adapting the clinical development strategy, including trial strategy and design while working closely with Medical Affairs to develop the appropriate communications for FBM, Patient Advocacy and Professional Relations, appropriate publication strategies and plans. The position will require some travel primarily to conferences and Key External Expert (KEE) meetings.

Key Responsibilities:

• Cross collaborates with VP Clinical Development, Sr. Director, 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 plans.
• Fulfills the day-to-day medical oversight of clinical trials in all clinical development programs initiated by Avalyn Pharma
• Works collaboratively with 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 input of external experts' and patient’s feedback into 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
• Oversees, in collaboration with VP, Clinical Development and Sr. Director, Clinical Development, the lifecycle management of Avalyn compounds 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
• 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
• 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 preferred but not required.
• 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