Executive Medical Director
$230k - $330kFull-time
Rhythm Pharmaceuticals
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview
Rhythm seeks an experienced, strategic, and highly motivated physician to join its Clinical Development team in Boston, Massachusetts. Within the clinical development group, there are multiple ongoing and planned clinical studies of setmelanotide and novel pipeline candidates across rare neuroendocrine and genetic metabolic indications. As an Executive Medical Director, this physician will serve as a senior clinical leader with primary accountability for the design, execution, and oversight of multiple clinical development programs across the development lifecycle (Phase 1–3), providing strategic leadership across one or more disease areas and ensuring alignment of clinical strategy across studies, indications, and lifecycle management opportunities. The role encompasses end-to-end clinical strategy, protocol architecture, medical monitoring oversight, clinical safety leadership, and clinical ownership of global regulatory submissions and health authority interactions. This high-visibility position will collaborate extensively across executive leadership, cross-functional development teams, and external scientific networks, while serving as a mentor and trusted advisor across the Clinical Development organization and providing guidance to other Medical Directors on study strategy, execution, regulatory interactions, and development best practices. Responsibilities and Duties
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are:
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview
Rhythm seeks an experienced, strategic, and highly motivated physician to join its Clinical Development team in Boston, Massachusetts. Within the clinical development group, there are multiple ongoing and planned clinical studies of setmelanotide and novel pipeline candidates across rare neuroendocrine and genetic metabolic indications. As an Executive Medical Director, this physician will serve as a senior clinical leader with primary accountability for the design, execution, and oversight of multiple clinical development programs across the development lifecycle (Phase 1–3), providing strategic leadership across one or more disease areas and ensuring alignment of clinical strategy across studies, indications, and lifecycle management opportunities. The role encompasses end-to-end clinical strategy, protocol architecture, medical monitoring oversight, clinical safety leadership, and clinical ownership of global regulatory submissions and health authority interactions. This high-visibility position will collaborate extensively across executive leadership, cross-functional development teams, and external scientific networks, while serving as a mentor and trusted advisor across the Clinical Development organization and providing guidance to other Medical Directors on study strategy, execution, regulatory interactions, and development best practices. Responsibilities and Duties
- Program & Study Leadership: Serve as the Clinical / Medical Lead across multiple complex clinical studies and development programs, ensuring high-quality trial execution, patient safety, and scientific integrity. Act as a senior clinical development resource within the organization, providing scientific and operational guidance to fellow Medical Directors and study teams.
- Clinical Development Planning & Protocols: Lead the creation, optimization, and execution of comprehensive Clinical Development Plans (CDPs) and innovative study protocols for new indications, lifecycle management activities, and future pipeline opportunities.
- Cross-Functional Matrix Leadership: Provide strategic medical and scientific leadership across cross-functional matrix teams, including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Translational Research, and Drug Safety / Pharmacovigilance.
- Medical Monitoring Oversight: Provide physician oversight for medical monitoring activities, including subject eligibility evaluation, protocol deviations, endpoint assessment, and emerging clinical issues.
- Safety & Pharmacovigilance Strategy: Provide clinical safety leadership across assigned programs, including review of aggregate safety data, SAE evaluation, Benefit-Risk evaluation, and collaboration with Pharmacovigilance to support patient safety.
- Global Regulatory Filings & Defense: Lead the clinical authoring, review, and defense of key regulatory documents (including INDs, Briefing Packages, Investigator’s Brochures [IBs], Clinical Study Reports [CSRs], and NDA/BLA/MAA clinical modules) and serve as a primary clinical representative in meetings with the FDA, EMA, and other global health authorities.
- Data Interpretation & Dissemination: Direct interpretation, synthesis, and reporting of complex clinical data from ongoing and completed trials, contributing to high-impact peer-reviewed publications, congress presentations, and internal executive briefings. Provide leadership in the interpretation of complex clinical data and support less-experienced team members in developing data interpretation and communication skills.
- KOL & Advisory Board Engagement: Establish and maintain collaborative partnerships with external Key Opinion Leaders (KOLs), investigators, academic collaborators, and study sites; support and participate in Scientific Advisory Boards and Data Safety Monitoring Boards (DSMBs).
- Mentorship & Team Development: Mentor, guide, and support Medical Directors and cross-functional study team members, sharing clinical development expertise and serving as a resource for protocol design, medical monitoring, regulatory strategy, and study execution. Help strengthen organizational capabilities through knowledge sharing, best practices, and informal leadership across the Clinical Development function.
- Medical Degree & Certification: Doctor of Medicine (MD) or equivalent international medical degree required; Board Certification in Endocrinology, Pediatrics, Genetics, Internal Medicine, or a related specialty preferred.
- Clinical Development Experience: Minimum of 8-10 years of clinical development experience within the pharmaceutical or biotechnology industry, including experience leading global clinical development programs and regulatory interactions; Experience in rare disease, endocrinology, obesity, metabolic disease, pediatrics, or related therapeutic areas strongly preferred.
- Clinical Development Leadership Experience: Demonstrated success serving as a senior medical leader within a Clinical Development organization, including mentoring and developing other physicians and providing technical leadership across multiple studies or programs.
- Trial Phase Track Record: Demonstrated track record of successful clinical trial design, medical oversight, and execution across Phase 1 through Phase 3 clinical studies, including registrational/pivotal trials.
- Regulatory Submissions & Interactions: Proven experience leading clinical components of global regulatory filings (IND/NDA/BLA/MAA) and direct participation in formal interactions with regulatory agencies (e.g., FDA, EMA, PMDA).
- GCP, Compliance & Safety Standards: Deep expertise in GCP/ICH guidelines, pharmacovigilance reporting standards, ethical conduct of clinical trials, and global clinical regulatory policies.
- Leadership & Matrix Influence: Exceptional leadership and matrix collaboration capabilities, with demonstrated success influencing cross-functional teams and external stakeholders and serving as a trusted subject matter expert and mentor within a Clinical Development organization.
- Strategic Mindset: Demonstrated ability to balance scientific rigor, patient needs, regulatory requirements, and business priorities within a fast-paced biotech environment.
- Executive Communication: Superior written, verbal, and presentation communication skills, with the ability to convey complex medical/scientific concepts clearly to diverse internal and external audiences.
- Travel: Ability to travel domestically and internationally as necessary (up to 20%).
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are:
- We are committed to advancing scientific understanding to improve patients’ lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
Vacancy posted 6 days ago
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