Vice President, Clinical Development & Medical Affairs

Transforming Lives with Breakthrough Therapies!

At Lumos Pharma, we are on a mission to revolutionize the treatment of rare diseases. As a cutting-edge clinical-stage biopharmaceutical company, we are focused on developing innovative therapies where the need is greatest and the science is clear. Our unwavering commitment is to bring safe, effective, and innovative treatments to patients through a strategy that values time and cost efficiency.

Join us in our pursuit to make a difference. Together, we can change the future of medicine!

The Vice President of Clinical Development and Medical Affairs will lead and oversee all clinical development programs and medical affairs activities in the endocrinology therapeutic area, with a particular focus on advancing clinical trials and developing strategies for drug approval and post-market support. This role involves close collaboration with regulatory bodies, research teams, and key stakeholders to ensure that clinical programs align with company objectives and regulatory requirements. The ideal candidate will bring a robust background in clinical development, a deep understanding of endocrinology, and the strategic acumen to drive clinical and medical affairs initiatives.

Key Responsibilities

Clinical Development Leadership

• Oversee the design, implementation, and execution of clinical trials from Phase I through Phase IV, ensuring alignment with regulatory standards and company objectives.
• Develop and implement clinical development plans that support regulatory submissions, collaborating closely with regulatory affairs to ensure timely submissions and responses.
• Serve as the clinical lead for interactions with regulatory bodies, including FDA, EMA, and other international agencies.
• Lead a multidisciplinary team, including clinical operations, biometrics, data management, and pharmacovigilance, ensuring efficient project management and resource allocation.
  
  
  

Medical Affairs Leadership

• Develop and execute the medical affairs strategy to support the endocrinology portfolio, focusing on medical education, publications, and KOL engagement.
• Provide strategic direction for scientific communications, including data dissemination, conference presentations, and scientific publication preparation.
• Collaborate with marketing, commercial, and research teams to create and execute plans that support product launches, field medical support, and market access.
• Establish and maintain strong relationships with key opinion leaders (KOLs), advocacy groups, and professional societies in endocrinology.
• Stakeholder Engagement and Cross-Functional Collaboration
• Act as the primary liaison between clinical development, medical affairs, and other departments, ensuring alignment across pre-clinical, clinical, and commercial activities.
• Collaborate closely with R&D, regulatory affairs, commercial, and manufacturing teams to seamlessly integrate clinical and medical strategies into product lifecycle management.
• Represent the company at scientific and medical conferences, providing thought leadership and maintaining a high profile within the endocrinology community.
• Strategic Planning and Budget Management
• Develop and manage the budget for clinical development and medical affairs, ensuring efficient resource use and alignment with company financial objectives.
• Provide strategic input to executive management, advising on clinical and medical risks, opportunities, and industry trends.
• Identify and manage relationships with CROs, vendors, and other external partners critical to executing clinical trials and medical affairs initiatives.
  
  
  

Qualifications

• Education: MD, DO, or PhD in a relevant field; board certification in endocrinology or a related specialty is highly preferred.
• Experience: Minimum of 15 years of experience in clinical development and/or medical affairs within the biotechnology or pharmaceutical industry, with at least 5 years in a senior leadership role.
• Technical Expertise: Demonstrated experience in endocrinology, with an in-depth understanding of clinical development processes, regulatory requirements, and post-approval medical affairs activities.
• Leadership: Proven ability to lead cross-functional teams, influence at all levels of an organization, and develop strategic initiatives that drive clinical and medical objectives.
• Communication Skills: Excellent written and oral communication skills, with the ability to effectively present complex clinical information to diverse audiences, including regulatory agencies, KOLs, and internal stakeholders.
• Analytical and Strategic Thinking: Strong problem-solving and decision-making skills, with the ability to analyze complex scientific data and develop innovative solutions to address clinical and medical challenges.
• Strategic and forward-thinking, passionate about advancing endocrinology clinical programs.
• Collaborative and adaptable, focusing on cross-functional alignment and team leadership.
• Highly accountable, detail-oriented, and able to prioritize in a fast-paced environment.
  
  
  

WORK ENVIRONMENT

This position can work remotely in the United States.

TRAVEL EXPECTATION

Up to 35%

Transforming Lives with Breakthrough Therapies!

At Lumos Pharma, we are on a mission to revolutionize the treatment of rare diseases. As a cutting-edge clinical-stage biopharmaceutical company, we are focused on developing innovative therapies where the need is greatest and the science is clear. Our unwavering commitment is to bring safe, effective, and innovative treatments to patients through a strategy that values time and cost efficiency.

Join us in our pursuit to make a difference. Together, we can change the future of medicine!

The Vice President of Clinical Development and Medical Affairs will lead and oversee all clinical development programs and medical affairs activities in the endocrinology therapeutic area, with a particular focus on advancing clinical trials and developing strategies for drug approval and post-market support. This role involves close collaboration with regulatory bodies, research teams, and key stakeholders to ensure that clinical programs align with company objectives and regulatory requirements. The ideal candidate will bring a robust background in clinical development, a deep understanding of endocrinology, and the strategic acumen to drive clinical and medical affairs initiatives.

Key Responsibilities

Clinical Development Leadership

• Oversee the design, implementation, and execution of clinical trials from Phase I through Phase IV, ensuring alignment with regulatory standards and company objectives.
• Develop and implement clinical development plans that support regulatory submissions, collaborating closely with regulatory affairs to ensure timely submissions and responses.
• Serve as the clinical lead for interactions with regulatory bodies, including FDA, EMA, and other international agencies.
• Lead a multidisciplinary team, including clinical operations, biometrics, data management, and pharmacovigilance, ensuring efficient project management and resource allocation.
  
  
  

Medical Affairs Leadership

• Develop and execute the medical affairs strategy to support the endocrinology portfolio, focusing on medical education, publications, and KOL engagement.
• Provide strategic direction for scientific communications, including data dissemination, conference presentations, and scientific publication preparation.
• Collaborate with marketing, commercial, and research teams to create and execute plans that support product launches, field medical support, and market access.
• Establish and maintain strong relationships with key opinion leaders (KOLs), advocacy groups, and professional societies in endocrinology.
• Stakeholder Engagement and Cross-Functional Collaboration
• Act as the primary liaison between clinical development, medical affairs, and other departments, ensuring alignment across pre-clinical, clinical, and commercial activities.
• Collaborate closely with R&D, regulatory affairs, commercial, and manufacturing teams to seamlessly integrate clinical and medical strategies into product lifecycle management.
• Represent the company at scientific and medical conferences, providing thought leadership and maintaining a high profile within the endocrinology community.
• Strategic Planning and Budget Management
• Develop and manage the budget for clinical development and medical affairs, ensuring efficient resource use and alignment with company financial objectives.
• Provide strategic input to executive management, advising on clinical and medical risks, opportunities, and industry trends.
• Identify and manage relationships with CROs, vendors, and other external partners critical to executing clinical trials and medical affairs initiatives.
  
  
  

Qualifications

• Education: MD, DO, or PhD in a relevant field; board certification in endocrinology or a related specialty is highly preferred.
• Experience: Minimum of 15 years of experience in clinical development and/or medical affairs within the biotechnology or pharmaceutical industry, with at least 5 years in a senior leadership role.
• Technical Expertise: Demonstrated experience in endocrinology, with an in-depth understanding of clinical development processes, regulatory requirements, and post-approval medical affairs activities.
• Leadership: Proven ability to lead cross-functional teams, influence at all levels of an organization, and develop strategic initiatives that drive clinical and medical objectives.
• Communication Skills: Excellent written and oral communication skills, with the ability to effectively present complex clinical information to diverse audiences, including regulatory agencies, KOLs, and internal stakeholders.
• Analytical and Strategic Thinking: Strong problem-solving and decision-making skills, with the ability to analyze complex scientific data and develop innovative solutions to address clinical and medical challenges.
• Strategic and forward-thinking, passionate about advancing endocrinology clinical programs.
• Collaborative and adaptable, focusing on cross-functional alignment and team leadership.
• Highly accountable, detail-oriented, and able to prioritize in a fast-paced environment.
  
  
  

WORK ENVIRONMENT

This position can work remotely in the United States.

TRAVEL EXPECTATION

Up to 35%