Senior Director, Head of Clinical Development MDs

Found in: Jooble US O C2 - 3 weeks ago

Boston MA, United States Atlas Venture Full time
Senior Director, Head of Clinical Development MDs
  • Company Address: 21 Hickory Drive, Suite 500, Waltham, MA, 02451
About Sionna Therapeutics Dedicated to delivering therapies that could be transformational for people living with cystic fibrosis.

About Sionna Therapeutics Dedicated to delivering therapies that could be transformational for people living with cystic fibrosis. Job Description

Sionna Therapeutics is a life sciences company dedicated to developing highly effective and differentiated treatments for cystic fibrosis (CF) by normalizing the function of CFTR, the key protein associated with disease progression in CF. Building on over a decade of extensive research on the genetic mutations associated with CF and founded in 2019, Sionna is advancing a pipeline of small molecules engineered to correct the protein defects caused by ΔF508, the most common mutation that affects the CFTR protein. The company has a first-in-class portfolio of programs targeting correction of NBD1, the key and unique mechanism to enable full restoration of ΔF508-CFTR function, and complementary programs targeting ICL4 and TMD1. Sionna’s pipeline has the potential to deliver best-in-class efficacy and reach previously unachievable levels of long-term benefit for people with CF.

Position Summary

Sionna Therapeutics is seeking a Senior Director to join the Clinical Development team and lead the Clinical Development MD function across all clinical studies and activities in Sionna’s growing portfolio; this individual will also serve as the lead safety physician with management responsibility for Pharmacovigilance. The Senior Director must have strong industry experience as a leader of clinical study and program teams and as a medical monitor, a track record of successful execution and oversight of clinical trial components (e.g., protocol development, medical trial oversight, clinical data review and interpretation), a strong understanding of clinical trial safety oversight, experience with regulatory submissions and interactions, and a background of relevant clinical experience. The position is based in the greater Boston area, with the opportunity to craft a flexible hybrid work schedule including in-person and remote work as part of Sionna’s Flexible First workforce strategy. This position reports to the Chief Medical Officer.

  • Lead the Clinical Development MD function responsible for medical direction and oversight of all Sionna clinical trials, including direct oversight of selected trials and management responsibility for contract medical monitors, and management of additional FTEs as the function grows
  • Serve as the lead safety physician (with Pharmacovigilance support), including review and/or oversight of all safety reports and safety regulatory submissions, and management of Pharmacovigilance personnel
  • Lead and/or oversee protocols and study design, strategy and execution, including clinical data review and interpretation, across Sionna’s portfolio and all stages of clinical development, collaborating closely with internal and external stakeholders to successfully plan and execute clinical development plans
  • Lead and/or oversee all DSMB meetings and activities
  • Key contributor and participant for regulatory interactions and documents, authoring and/or reviewing relevant documents and sections (e.g., Investigators Brochures, INDs/CTAs, briefing documents and regulatory responses); critical participant in crafting and refinement of Sionna’s regulatory strategy
  • Serve as a key thought partner to CMO on Clinical Development strategy and plans
  • Provide clinical input and direction into Sionna’s pipeline, serving as a key clinical resource to research, toxicology, DMPK, CMC and other internal stakeholders
  • Responsible for creating and/or maintaining selected GCP SOPs and providing input into other GCP elements of QMS, in collaboration with QA and other Development functions
  • Serve as the primary responsible person for internal and external clinical data presentations and publications
Minimum Qualifications:
  • MD or equivalent with at least 5 years’ industry experience in a Clinical Development MD role; at least 10 years’ clinical experience including a background of patient care and clinical and/or bench research; industry experience in pulmonary or rare disease therapeutic areas is a plus, and specialization in pulmonary, allergy, infectious disease or a relevant sub-specialty highly desired
  • Hands-on experience as a clinical trial medical monitor including assessing clinical trial and subject-level safety data, and experience overseeing contractors and/or other personnel responsible for clinical trial medical oversight and execution
  • Experience with key regulatory documents and milestones including INDs/CTAs, briefing documents, regulatory responses; experience with FDA is required, experience with global clinical trials and ex-US regulatory authorities is a plus
  • Working knowledge of GCP and ICH
  • Ability to work collaboratively across diverse teams
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