Director/Senior Director, Clinical Development

3 days ago

Gaithersburg, United States Altimmune Full time
Job DescriptionJob Description

Altimmune (NASDAQ: ALT) is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemuvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com.

Job Description: To address Altimmune's increasing clinical needs, the Company seeks a Director/Senior Director, Clinical Development, to drive the clinical research strategy for the obesity and liver disease candidates. The candidate will be expected to ensure that all programs meet the quality and safety standards required by the medical community and regulatory agencies. You will work as part of a cross-functional team to deliver on a high-priority program while contributing to a dynamic and collaborative Clinical Research community of physicians and scientists. The candidate can operate at a high strategic level and execute at a tactical level easily. The candidate will also play important roles in business development activities and report to the Vice President, Clinical Development.

Essential Functions:

  • Participate in developing Altimmune's clinical and regulatory strategy for pemvidutide, its obesity, and MASH product candidate.
  • Works closely with cross-functional leaders and teams to develop, implement, and oversee the clinical development strategy for the assigned products
  • Manage internal and external resources to ensure clinical research plans are executed on time and within budget.
  • Develop clinical trial protocols, investigator brochures, and other documents required to conduct clinical trials.
  • Oversee management of clinical trials, including investigator selection, analysis of patient recruitment strategies, milestones, coordination of lab samples, data collection, and analysis.
  • Identify suitable clinical trial sites and develop effective working relationships with clinical investigators and thought leaders.
  • Engage with the Pharmacovigilance team to ensure strategic alignment in understanding and managing safety events pertaining to protocol amendments and external communications (Regulatory Authorities, IRBs, Investigators).
  • Develop regulatory filings, including drafting, editing, and preparing routine correspondence and sections of INDs, BLAs, NDA's, Annual Reports, Amendments, Supplements, Orphan Drug Applications, and other regulatory submissions.
  • Contribute to the development and maintenance of clinical SOPs related to GCP activities.
  • Ensure that all Altimmune's clinical programs are conducted in accordance with Good Clinical Practice (GCP), ICH guidelines and all applicable regulatory requirements.
  • Provide expert opinion and due diligence research on business development opportunities.
  • Participate in analyzing and organizing data for publication, participate in generating and submitting abstracts, and develop and present posters and slide decks for conferences.

Job Requirements (Essential knowledge, skills, and attributes):

  • A medical degree/MD, with a background in hepatology or metabolic diseases (diabetes, obesity), is preferred.
  • Minimum five (5) years clinical development experience in the biopharma industry
  • Background in the development of clinical trial protocols and regulatory briefing documents or submissions.
  • Experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
  • The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire or request a medical or religious accommodation.

Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.



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