Medical Director/Medical Monitor (Diabetes Focus)

We are currently seeking a physician to serve as a key medical lead for our clinical trials, focusing on our diabetes program(s). This role offers an exciting opportunity to shape the strategic direction of clinical studies, ensure patient safety, and contribute directly to the successful development and approval of a novel treatment for diabetes. Responsibilities will include but are not limited to: providing medical oversight, interpreting clinical data, and collaborating with investigators, regulatory authorities, and key opinion leaders. Our Company is led by an experienced team of scientific thinkers, drug developers, and entrepreneurs.

We have recently secured funding from a world-class syndicate of venture capital investors to progress our novel, targeted drug candidate into a Phase 2b dose range finding clinical trial for a subset of patients with treatment resistant Type 2 Diabetes Mellitus (T2D).

Key Responsibilities:

Medical Oversight & Safety:

• Serve as the lead medical monitor for assigned clinical trials in diabetes, ensuring patient safety and well-being.
• Review and assess reported adverse events (AEs) and, in real-time, serious adverse events (SAEs), providing medical expertise for causality assessment and reporting.
• Develop and implement medical monitoring plans and safety surveillance strategies.
• Develop and support Data Monitoring Committees (DMCs) or Event Adjudication Committees (EACs).

Clinical Development Strategy:

• Participate in the strategic planning and execution of clinical development programs for diabetes indications.
• Contribute to design, development, and authoring of clinical study protocols (Phase I-IV) in diabetes.
• Provide medical oversight of clinical trial conduct, protocol adherence, Good Clinical Practice (GCP), and regulatory requirements.

Data Interpretation & Reporting:

• Conduct medical review and interpretation of clinical trial data, including efficacy and safety endpoints.
• Contribute to the preparation of clinical study reports (CSRs), regulatory submissions (e.g., INDs, NDAs, BLAs), and other clinical documentation.
• Present clinical data internally and externally to scientific, medical, and regulatory audiences.

External Engagement:

• Act as a medical expert and primary point of contact for clinical investigators and site staff regarding medical questions and issues.
• In collaboration with Medical Affairs, establish and maintain strong relationships with clinical and scientific advisors and external experts in the diabetes, endocrine, and general medicine fields.
• Represent the company at scientific conferences, advisory boards, and regulatory meetings.

Cross-Functional Collaboration:

• Collaborate effectively with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, Medical Affairs, Program Management and Finance.
• Provide medical leadership and guidance to internal teams.

Qualifications:

• MD Degree: Medical Doctor (M.D.) or equivalent degree from an accredited institution.
• Board Certification/Eligibility: Board Eligible/Certified in Internal Medicine, Endocrinology, or a related specialty.
• Clinical Experience: At least 5 years of clinical experience (including residency/fellowship).
• Pharmaceutical/Biotech Experience: A minimum of 5 years of experience as a Medical Director, Medical Monitor, or equivalent role within the pharmaceutical or biotechnology industry, including at least 2 years of recent experience in Phase 2/3 clinical trials in patients with type 2 diabetes.
• Therapeutic Area Expertise: Proven expertise and in-depth knowledge of type 2 diabetes and related cardio-metabolic disorders, including current treatment paradigms, clinical trial design, and regulatory landscape.
• Clinical Trial Acumen: Strong understanding of clinical trial methodology, study design, statistical principles, and data interpretation.
• Regulatory Knowledge: Familiarity with global regulatory requirements and guidelines (e.g., FDA, EMA, ICH GCP).
• Communication Skills: Excellent written and verbal communication skills, with the ability to effectively present complex medical information to diverse audiences.
• Analytical & Problem-Solving Skills: Strong analytical skills and ability to critically evaluate scientific and clinical data.
• Collaboration & Leadership: Demonstrated ability to work collaboratively in a team environment and provide medical leadership.

Fit with Sparrow Culture

• Values-based leadership consistent with Sparrow’s Core Values: Respect, Tenacity, Compassion, Creativity, and Alacrity.
• Partners effectively. Demonstrates proactive collaboration with internal partners/stakeholders including Clinical/Medical, Safety, Regulatory, QA, Project Management, and other colleagues. Foster partnerships across existing multi-disciplinary teams.
• Proven track record in creating and maintaining an inclusive, collaborative, and dynamic team-focused work environment.
• Ability to build strong relationships with co-workers of diverse backgrounds and expertise.
• Ability to effectively participate at a high level within a team setting, whether leading the group or acting as an individual contributor.
• Willing to travel for internal corporate and external investigator, site, and scientific meetings, both nationally and internationally. Travel is estimated at 20-30%.
• Works effectively in a virtual team environment with schedule flexibility to build and maintain relationships across time zones potentially from eastern Europe to Australia.
• Displays humility and humor alongside excellence and expertise.

Please visit our website at www.sparrowpharma.com

Qualified candidates are invited to submit their cv and cover letter through  Show Contact Details 
No agencies please

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