Neurological Rare Diseases Medical Director - Part Time

Software Guidance & Assistance, Inc., (SGA), is searching for a Neurological Rare Diseases Medical Director - Part Time for a contract assignment with one of our premier Pharmaceutical clients in South San Francisco, CA.

Responsibilities :

• Provide exceptional clinical and scientific leadership for medical affairs activities, with a major focus on evidence generation/medical monitoring.
• 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.
• 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.
• Scientific Engagement: Contribute to broader Medical Affairs activities, including providing a clinically meaningful perspective for regulatory and other scientific communications, and engaging with firm's internal and external stakeholders.
• Cross-Functional Leadership: Represent the US Medical function within cross-functional teams and initiatives at firm and within the firm's 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.

Required Skills:

• 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.

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy
#LI-PA2