Director / Associate Director, Medical Affairs

Job Description

Job Description

Director / Associate Director Medical Affairs - Precision Medicine: focusing on companion diagnostics (CDx) strategy and the development of medical affairs strategies for Predicine CDx launches.

In this role you are responsible for developing and implementing medical affairs strategies related to biomarkers and diagnostic tests (CDx). This individual will drive evidence generation, manage key opinion leaders, and ensure alignment with overall product and pipeline strategies. You will provide scientific expertise and contribute to the development of marketing materials and educational programs.

This role may include supporting clinical trial design, data analysis, and publication strategies, as well as engaging with key opinion leaders (KOLs) and healthcare providers.

• Scientific and Clinical Expertise: Providing medical and scientific presentations on data supporting Predicine’s oncology products, including companion diagnostics
• Collaboration: Working with cross-functional teams, including bioinformatics, marketing, bio-pharma business development, as well as lab operations, to ensure alignment on clinical and scientific information
• Key Opinion Leader (KOL) Engagement: Building and maintaining relationships with KOLs, healthcare providers, and customers in oncology
• Clinical Trial Support: Collaborating on clinical trial design, data analysis, and publication strategies, potentially involving international studies
• Medical Writing & Review: Contributing to the development and review of clinical documents, such as Clinical Performance Study Plans (CPSPs), Investigator's Brochures (IBs), and Performance Study Reports (PSRs)
• Regulatory Compliance: Ensuring that clinical studies and related documentation adhere to relevant regulations
• Strategic vision: This involves leveraging clinical biomarkers to enhance the value of the portfolio and collaborating with research, clinical development, commercial, regulatory, and other functional areas
• Scientific accuracy: This includes reviewing and approving marketing materials, medical education programs, and other scientific communications

Key Skills and Qualifications :

• Doctorate, PharmD or MD is preferred. MSc degree in scientific related discipline and demonstrated medical affairs experience will also be considered.
• Previous experience in diagnostic areas
• Relevant Oncology/solid tumors and biomarker background is considered an asset
• Knowledge of scientific methods applied to clinical research, biomarker testing implementation/validation, and the current legislative/regulatory controls

Essential Skills & Abilities :

• Proficient with Microsoft Office Suite (Outlook, PowerPoint, Excel, Word, etc.)
• Must be at ease with technology (the use of various tools/systems to perform day-to-day tasks)
• Ability to understand the unmet needs of key stakeholders, make decisions that have an impact and execute the integration and assimilation of that information

Predicine is a Silicon Valley-based global precision medicine company committed to developing best-in-class liquid biopsy cancer diagnostics and a comprehensive precision medicine portfolio to address unmet medical needs in global drug development.

We have pioneered an innovative liquid biopsy technology that empowers biopharma partners in clinical drug development and oncology research. At Predicine, we believe our most important asset is our people, and we are dedicated to maintaining a thriving and collaborative workplace. We value a culture of Integrity, Innovation, Quality, Respect, Courage, Collaboration, Caring, and Communication.

Benefits:

We offer a competitive salary, comprehensive benefits, and opportunities for professional growth and development. Employee benefits include medical, dental, and vision coverage for eligible employees and their dependents. Additional benefits include stock allocation, 401(k), a 4-week sabbatical after 5 years of service, and daily lunch provided for onsite employees.

Our Opportunity:

We are proud to be an Equal Opportunity Employer. We are committed to fostering a diverse and inclusive workplace and encourage people from all backgrounds, experiences, abilities, and perspectives to apply. Inclusive collaboration benefits our employees, community, and patients, and is essential to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability, or any other legally protected status. We also consider qualified applicants regardless of criminal histories, in compliance with applicable laws.

Compensation decisions are based on several factors, including qualifications, location, internal equity, and market data alignment.

All job offers are contingent upon successful completion of background verification.

Applicants must be legally authorized to work in the USA without sponsorship now or in the future.

Note: We are not accepting third-party resumes from recruiters, recruiting agencies, or third-party vendors.