[Hiring] Senior Medical Director @Lumos Pharma

Role Description

The Senior Medical Director, Clinical Development will provide scientific and clinical expertise to guide the development of innovative therapies for endocrine disorders. Upon hire, the primary focus for the role will be on our OraGrowtH Phase 3 study. This individual will be instrumental in driving all clinical development strategy, ensuring regulatory compliance, and advancing clinical trials from early through late stages. The role requires close collaboration with all departments to optimize clinical trial design and implementation and enhance medical and scientific understanding for all three study areas, including PGHD, Obesity, and Radiation Necrosis.

Key Responsibilities

• Direct Investigator Engagement: Own the medical contribution to investigator engagement, while Clinical Operations retains operational accountability.
• Site and Investigator Support:
  • Visit priority sites and build relationships with referring endocrinologists.
  • Resolve medical questions on eligibility, screening, and protocol interpretation in a timely manner.
  • Help address recruitment barriers and support clear explanations of the study to families.
  • Strengthen patient retention and adherence.
• Medical Oversight and Safety:
  • Serve as the sponsor medical lead for assigned studies and oversee any outsourced medical monitoring.
  • Review emerging safety information with Pharmacovigilance and escalate concerns promptly.
  • Provide timely medical guidance to sites and CRO physicians.
  • Review important protocol deviations, eligibility questions, and clinical data trends.
  • Support independent safety committee activities, where applicable, while preserving blinding.
• Clinical Strategy & Program Leadership:
  • Lead the development of clinical strategies and plans for endocrine-related therapies, including clinical trial design, protocol development, and execution.
  • Drive the scientific and clinical aspects of the clinical development program to ensure alignment with overall corporate and regulatory objectives.
  • Oversee the planning and execution of our near-term Phase II and Phase III clinical trials in collaboration with cross-functional teams, ensuring that studies meet ethical and regulatory standards.
• Clinical Trial Oversight:
  • Ensure successful trial execution, including protocol design, study feasibility, patient recruitment, data collection, and analysis.
  • Collaborate with Clinical Operations to ensure adherence to trial timelines and budgets and proactively identify and address potential issues.
  • Support data review and interpretation, providing critical insights for clinical reports and publications.
• Regulatory & Compliance Support:
  • Partner with Regulatory Affairs to prepare and review regulatory submissions (INDs, NDAs, MAAs) and provide clinical and scientific support for interactions with regulatory agencies, including the FDA, EMA, and other health authorities.
  • Ensure that clinical programs comply with GCP, ICH, and other regulatory guidelines.
• Medical Education and Scientific Communication:
  • Act as an endocrinology clinical and scientific expert for internal and external stakeholders, including opinion leaders, clinical investigators, and advisory boards, particularly within the endocrinology field.
  • Communicate clinical trial results and product information to the medical community with development and delivery of scientific presentations, clinical study reports, and publications.
  • Collaborate with the Medical Affairs team on post-approval studies, real-world evidence generation, and publication plans.
• Cross-Functional Collaboration:
  • Partner with Lumos teams to provide clinical input on product development, launch strategies, and lifecycle management of the endocrine portfolio.
  • Work with Leadership to support product differentiation, competitive positioning, and value proposition in the endocrinology market.
  • Support patient advocacy and engagement activities.
• Stakeholder Engagement & Thought Leadership:
  • Establish and maintain strong relationships with key opinion leaders (KOLs), patient advocacy groups, and other external stakeholders in endocrinology.
  • Represent the company at scientific and medical conferences and in medical advisory board meetings.
• Budgetary Responsibilities:
  • Responsible for financial and compliance controls as they relate to my role, specifically in identifying the cost and timeline implications of clinical decisions.

Qualifications

• MD or equivalent, with relevant clinical training
• Industry experience in clinical development 7+ years with direct responsibility for interventional clinical development
• Experience with medical monitoring, investigators and CRO oversight
• Direct responsibility for regulatory interactions and medical communications as it relates to clinical trials
• Demonstrated ability and effort to maintain positive culture and team dynamics in the Medical Director role
• Evidence of resolving trial execution problems in a small company or similarly accountable role
• Proven ability to design, execute, and interpret clinical trials.
• Ability to make sound decisions and work effectively across functions

Requirements

• Pediatric endocrinology training and growth hormone expertise
• Multinational pediatric or rare disease trials
• Late-stage development through submission
• Obesity, metabolic disease or incretin combination development
• Established investigator relationships in relevant geographies

Competencies

• Leadership: Demonstrated ability to lead cross-functional teams and influence without direct authority.
• Leadership: Experience in mentoring and training junior team members
• Leadership: Demonstrated proven track record of leadership in current role through participation by leading projects or initiatives successfully
• Adaptability: Comfortable operating independently in a fast-moving, lean setting with limited predefined structure and sometimes ambiguity while balancing rigor and practicality.
• Adaptability: Energized by the opportunity to help build from the ground up and demonstrated.
• Adaptability: Demonstrated ability to work independently in a virtual environment
• Communication: Excellent communication skills, with the ability to clearly articulate complex scientific information to both technical and non-technical audiences.
• Communication: Competent and comfortable engaging and presenting in virtual engagement platforms (e.g., Zoom, Microsoft Teams)
• Relationship Building: Ability to work effectively in a cross-functional team environment and to build relationships with internal and external stakeholders.
• Relationship Building: Demonstrated ability and effort to maintain positive culture and team dynamics

Work Environment

• This position can work remotely in the United States.

Travel Expectation

• Up to 35%

Benefits

• Industry-competitive compensation
• Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life Insurance.
• Lumos covers 95 – 85% of medical insurance coverage premium
• Health Reimbursement Arrangement
• 8 weeks of fully paid parental leave for all new parents
• Gym or fitness class reimbursement
• 401(k) with 5% employer contribution
• Flexible work hours and location
• Generous PTO policy
• 11 paid holidays in the US
• Offices in Austin, TX and Ames, IA