Medical Director, Part-Time

???Medical Director, Part-timeLocation:Remote
Duration: 12-24 months
Part time role. 20 hours per week.

Job Description:
The NRD Medical Director will provide exceptional clinical and scientific leadership for medical affairs activities, with a major focus on evidence generation/medical monitoring. The successful candidate will leverage their extensive experience in late phase clinical development to bridge scientific insight with clinical execution to ensure that studies are medically sound, ethically conducted, and scientifically meaningful, producing evidence that informs real-world practice, supports product value, and enhances patient care.

Key Responsibilities
Evidence Generation/Medical Monitoring
- Contribute clinical expertise to assess unmet needs, evolving treatment landscape and evidence gaps in the area of neurological rare diseases.
- Align study execution with broader evidence-generation plans, real-world data strategies, and publication objectives.
- Serve as the primary medical voice and represent the medical/scientific perspective within the Study Management Team (SMT), working closely with all functions in the team.
- Provide clinical oversight to ensure the medical and scientific integrity of the study conduct, including adherence to the protocol, medical input to study deviations or amendments, and clinical impact of any protocol deviations or proposed changes
- Collaborate with the Global Safety Team lead to review safety data.
- Address medical questions from investigators or internal teams, ensuring timely and accurate responses.
- Lead the interpretation of clinical outcomes in the context of the disease and standard of care, in close collaboration with the SMT and NRD medical team.
- Contribute to abstracts, manuscripts, and congress presentations, ensuring accuracy and scientific balance.
- Support data communication to internal and external stakeholders (e.g., field medical teams, healthcare professionals).
- Ensure all activities adhere to company policies and applicable regulatory standards.
- Identify and mitigate clinical or ethical risks during study execution.
- Support regulatory or internal audits from a medical perspective.

Additional Responsibilities
- Scientific Engagement: Contribute to broader Medical Affairs activities, including providing a clinically meaningful perspective for regulatory and other scientific communications, and engaging with Genentech's internal and external stakeholders.
- Cross-Functional Leadership: Represent the US Medical function within cross-functional teams and initiatives at Genentech and within the Roche global organization. This
position requires flexibility in prioritizing work, and a mindset to engage in purposeful partnerships to achieve our medical strategies.
- Compliance: Act as a guardian for high standards of compliance, ethics, and safety, putting patients at the center of all actions.

Who you are
- MD is required
- Minimum 6+ years of relevant biopharmaceutical industry experience.
- Experience with later phase clinical development (eg, phase 3-4, and observational studies), including minimum 3+ years of relevant medical monitoring).
- Experience with Spotfire or similar data visualization and analytics platform used in clinical research and medical monitoring.
- Understanding of the US health care environment, including the payer landscape, marketplace factors/dynamics, evidence-based medicine tools and practices.
- Experience in other areas of Medical Affairs such as scientific communications and external engagement.
- Exceptional clinical judgment, outstanding communication and presentation skills, and the ability to lead and influence in a complex matrix organization.
- Proven record in developing strong relationships with external stakeholders (eg, therapeutic area experts, external organizations).
- Great team player; Highly collaborative; good interpersonal and influencing skills; can effectively and quickly establish rapport and influence without authority.

dtelschow@c4techservices.com