Medical Director
Salary undisclosed
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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 quest to make a difference. Together, we can change the future of medicine!
The Medical Director, Clinical Development and Medical Affairs – Endocrinology will provide scientific and clinical expertise to guide the development of innovative therapies for endocrine disorders. This individual will be instrumental in driving clinical development strategy, ensuring regulatory compliance, and advancing clinical trials from early through late stages. The role requires close collaboration with R&D, Regulatory, Commercial, and Market Access teams to optimize clinical trial design and implementation and enhance medical and scientific understanding in endocrinology.
Key Responsibilities
Clinical Strategy & Program Leadership
This position can work remotely in the United States.
TRAVEL EXPECTATION
Up to 35%
What You Can Expect As a Lumosian
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 quest to make a difference. Together, we can change the future of medicine!
The Medical Director, Clinical Development and Medical Affairs – Endocrinology will provide scientific and clinical expertise to guide the development of innovative therapies for endocrine disorders. This individual will be instrumental in driving clinical development strategy, ensuring regulatory compliance, and advancing clinical trials from early through late stages. The role requires close collaboration with R&D, Regulatory, Commercial, and Market Access teams to optimize clinical trial design and implementation and enhance medical and scientific understanding in endocrinology.
Key Responsibilities
Clinical Strategy & Program Leadership
- Lead the development and execution of clinical strategies and plans for endocrine-related therapies, including clinical trial design, protocol development, and clinical endpoint selection.
- 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 Phase I-IV clinical trials in collaboration with cross-functional teams, ensuring that studies meet ethical and regulatory standards.
- 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.
- 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.
- Act as a clinical and scientific expert for internal and external stakeholders, including opinion leaders, clinical investigators, and advisory boards, particularly within the endocrinology field.
- Develop and deliver scientific presentations, publications, and reports to effectively communicate clinical trial results and product information to the medical community.
- Collaborate with the Medical Affairs team on post-approval studies, real-world evidence generation, and publication plans.
- Partner with R&D, Commercial, and Market Access teams to provide clinical input on product development, launch strategies, and lifecycle management.
- Work with Marketing and Commercial teams to support product differentiation, competitive positioning, and value proposition in the endocrinology market.
- Support patient advocacy and engagement activities by providing clinical insights and fostering patient-centric program design.
- 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.
- Education: MD or equivalent with board certification in endocrinology or a closely related field.
- Experience: Minimum of 5-8 years of experience in clinical development or medical affairs within the biotech or pharmaceutical industry, with a focus on endocrinology (pediatric or adult). Experience with clinical trials, regulatory submissions, and medical communication is required.
- Expertise: Deep understanding of endocrine disorders, including clinical trial design and management in this therapeutic area, and familiarity with regulatory and compliance requirements.
- Proven ability to design, execute, and interpret clinical trials.
- Leadership: Demonstrated ability to lead cross-functional teams and influence without direct authority. Experience in mentoring and training junior team members is a plus.
- Strategic Vision: Ability to anticipate trends and challenges in endocrinology and adapt strategies to achieve clinical and commercial success.
- Problem-Solving: Strong analytical and critical thinking skills with a solution-oriented approach to clinical and operational challenges.
- Adaptability: Comfortable in a fast-paced, evolving environment, committed to continuous improvement.
- Analytical Skills: Strong analytical skills with a strategic mindset for clinical development and commercialization.
- Communication: Excellent communication skills, with the ability to clearly articulate complex scientific information to both technical and non-technical audiences.
- Relationship Builder: Ability to work effectively in a cross-functional team environment and to build relationships with internal and external stakeholders.
This position can work remotely in the United States.
TRAVEL EXPECTATION
Up to 35%
What You Can Expect As a Lumosian
- 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 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
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 quest to make a difference. Together, we can change the future of medicine!
The Medical Director, Clinical Development and Medical Affairs – Endocrinology will provide scientific and clinical expertise to guide the development of innovative therapies for endocrine disorders. This individual will be instrumental in driving clinical development strategy, ensuring regulatory compliance, and advancing clinical trials from early through late stages. The role requires close collaboration with R&D, Regulatory, Commercial, and Market Access teams to optimize clinical trial design and implementation and enhance medical and scientific understanding in endocrinology.
Key Responsibilities
Clinical Strategy & Program Leadership
This position can work remotely in the United States.
TRAVEL EXPECTATION
Up to 35%
What You Can Expect As a Lumosian
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 quest to make a difference. Together, we can change the future of medicine!
The Medical Director, Clinical Development and Medical Affairs – Endocrinology will provide scientific and clinical expertise to guide the development of innovative therapies for endocrine disorders. This individual will be instrumental in driving clinical development strategy, ensuring regulatory compliance, and advancing clinical trials from early through late stages. The role requires close collaboration with R&D, Regulatory, Commercial, and Market Access teams to optimize clinical trial design and implementation and enhance medical and scientific understanding in endocrinology.
Key Responsibilities
Clinical Strategy & Program Leadership
- Lead the development and execution of clinical strategies and plans for endocrine-related therapies, including clinical trial design, protocol development, and clinical endpoint selection.
- 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 Phase I-IV clinical trials in collaboration with cross-functional teams, ensuring that studies meet ethical and regulatory standards.
- 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.
- 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.
- Act as a clinical and scientific expert for internal and external stakeholders, including opinion leaders, clinical investigators, and advisory boards, particularly within the endocrinology field.
- Develop and deliver scientific presentations, publications, and reports to effectively communicate clinical trial results and product information to the medical community.
- Collaborate with the Medical Affairs team on post-approval studies, real-world evidence generation, and publication plans.
- Partner with R&D, Commercial, and Market Access teams to provide clinical input on product development, launch strategies, and lifecycle management.
- Work with Marketing and Commercial teams to support product differentiation, competitive positioning, and value proposition in the endocrinology market.
- Support patient advocacy and engagement activities by providing clinical insights and fostering patient-centric program design.
- 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.
- Education: MD or equivalent with board certification in endocrinology or a closely related field.
- Experience: Minimum of 5-8 years of experience in clinical development or medical affairs within the biotech or pharmaceutical industry, with a focus on endocrinology (pediatric or adult). Experience with clinical trials, regulatory submissions, and medical communication is required.
- Expertise: Deep understanding of endocrine disorders, including clinical trial design and management in this therapeutic area, and familiarity with regulatory and compliance requirements.
- Proven ability to design, execute, and interpret clinical trials.
- Leadership: Demonstrated ability to lead cross-functional teams and influence without direct authority. Experience in mentoring and training junior team members is a plus.
- Strategic Vision: Ability to anticipate trends and challenges in endocrinology and adapt strategies to achieve clinical and commercial success.
- Problem-Solving: Strong analytical and critical thinking skills with a solution-oriented approach to clinical and operational challenges.
- Adaptability: Comfortable in a fast-paced, evolving environment, committed to continuous improvement.
- Analytical Skills: Strong analytical skills with a strategic mindset for clinical development and commercialization.
- Communication: Excellent communication skills, with the ability to clearly articulate complex scientific information to both technical and non-technical audiences.
- Relationship Builder: Ability to work effectively in a cross-functional team environment and to build relationships with internal and external stakeholders.
This position can work remotely in the United States.
TRAVEL EXPECTATION
Up to 35%
What You Can Expect As a Lumosian
- 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 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