Medical Director/Senior Medical Director, Clinical Development

1 month ago

Waltham, United States Upstream Bio Full time

Position Summary

Upstream Bio is developing innovative therapeutics to treat inflammation. We are a nimble company with solid financial backing from high-quality investors. We have a clinical stage asset, verekitug, a fully human monoclonal antibody, with proof of concept in inflammation and plans to expand into other therapeutic areas. Our offices are in Waltham, MA. We have a hybrid working model for employees living in the Boston area, with Tuesdays-Thursdays in our Waltham office and Mondays and Fridays flexible to work remotely if desired.

We seek a highly motivated and experienced Medical Director/Senior Medical Director of Clinical Development to lead clinical program(s) for verekitug in COPD. This role will report to the Vice President, Clinical Development.

The successful candidate will be a leader in the organization, yill successfully maintain alignment and excellent communications with key stakeholders internally, and ably represent Upstream Bio to Investigators and in public presentations. The Medical Director/Senior Medical Director guides development of and approves Clinical Development strategies, priorities, final interpretation, and completion of clinical study results.


Excellent written and oral communication skills are required to represent the program to internal and external stakeholders, as is the desire and ability to work in a small, nimble, fast paced, and patient-focused environment. Adaptability to changing program needs and challenges and an innovative approach to problem solving will be important characteristics of the successful candidate.


Key Responsibilities:

  • Lead clinical programs (an asset in an indication) by producing, with a cross functional team, Clinical Development plans and study protocols.
  • In collaboration with Clinical Operations, be accountable for study conduct and execution according to approved timelines.
  • Ensure scientific integrity in the execution of clinical studies, data interpretation and communications.
  • Ensure adherence to GCP/ICH standards and internal SOPs in the conduct of clinical trials.
  • Drive the development and maintenance of Advisory Boards based on solid working relationships with KOLs and lead clinical investigators.
  • Work with team members to prepare publications and presentations for external meetings.
  • Provide strategic support for clinical strategies across development.
  • With VP, Clinical Development, may partner with business development on the evaluation and in-licensing/acquisition of external product development opportunities in alignment with the company’s strategy.
  • Support the company in establishing and maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.


Qualifications

  • MD with Board Certification in a relevant discipline such as Internal Medicine and ideally in the subspecialty of pulmonary/respiratory.
  • 5+ years of industry clinical development experience (ideally inflammatory/respiratory related diseases; COPD experience a plus).
  • Experience designing, developing, and/or overseeing others in the design and development of clinical studies and cross-functional initiatives.
  • Strong presentation skills at all levels including Scientific Advisory Boards and KOLs.
  • Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize workload on multiple ongoing projects.
  • Willingness and ability to travel domestically and internationally up to 25% of the time for business-related activities and meetings.
  • Strategic thinker and creative problem-solver capable of identifying risks and risk mitigation strategies.
  • Excellent judgement in making trade-off decisions for program scope, costs and strategy.
  • Strong interpersonal, communication, influencing, problem solving, skills.

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