Senior Director / Director, Medical Affairs

Senior Director / Director, Medical Affairs

Clinical Development South San Francisco, Hybrid

If the following job requirements and experience match your skills, please ensure you apply promptly.

JOB TITLE : Senior Director / Director, Medical Affairs

DEPARTMENT : Clinical Development

TYPE : Full-Time (Hybrid)

Are you a medical affairs leader with late stage into commercialization experience in kidney and / or immune-mediated diseases?

Join HI-Bio, Inc. , a clinical-stage biotechnology company based in South San Francisco, California, and be part of a fast-paced organization on an outstanding team of cross functional clinical research professionals translating scientific insights into our clinical development programs across a wide range of unmet needs.

Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact.

We have a precision medicine approach akin to oncology and grounded in human genetics. Our pipeline is strong and built through in-licensing and discovery.

HI-Bio's team is made up of industry experts from science and clinical development. We are on a path to building the leading immunology company.

To accomplish this, we are seeking top talent to join us on our journey.

We are seeking a senior medical affairs leader that will build a scalable medical affairs strategy for a fast-moving program and implement a design that will lead to clinical and commercial success for the program.

The Director will, over time, build a medical affairs team and plan all resources to successfully manage KOL and other external relationships as well as optimize late-stage planning.

The leader will have a deep background in all areas of medical affairs from medical communication, disease awareness, MSL activities, and other commercial teams.

As part of a small, adapting startup, the successful candidate will need to operate hands-on with external KOLs while maintaining a focus to scale the medical affairs strategy and team alongside the portfolio.

The position reports to the Chief Medical Officer and is based in South San Francisco, or hybrid.

KEY RESPONSIBILITIES :

• Build and lead a best-in-class global medical affairs team to support launches of multiple indications with a focus on our lead asset, felzartamab.
• Develop key performance indicators and generate analytical reports related to Medical Affairs plans and Medical Science Liaison group activities.
• Develop and implement Medical Communication and Disease State Awareness strategies.
• Partner with KOLs to gather information on current focused therapeutic area issues and questions.
• Collaborate with the Commercial team to develop educational material for providers and patients that are balanced and medically accurate.
• Provide direction and input into the development and implementation of successful reimbursement and market-access strategies.
• Work closely with the members of the clinical development and commercial leadership teams to develop the overall strategic direction for HI-Bio, evaluate alternative strategies, identify competitive issues, and develop and implement operating plans to achieve company objectives.
• Foster collaborative relationships with academic and clinical experts, publishers, medical and patient associations, and other relevant external and internal stakeholders.
• Develop and manage departmental budgets that effectively achieve desired goals that are balanced with the financial objectives of the broader organization.

QUALIFICATIONS :

• 10+ years of professional experience within Biotech / Pharma in Medical Affairs, within industry.
• Advanced degree in life sciences, pharmacy, business or medicine is highly preferred.
• 5+ years of people leadership experience.
• Possess an understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific / medical exchange and communication with customers.
• Ability to lead by example, attract and develop talent, build interdependent partnerships, and create a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution, and organizational flexibility.
• Able to prioritize and manage several complex projects simultaneously.
• Proven ability to develop internal relationships in a highly matrix environment, as well as external relationships with Key Opinion Leaders and industry experts.
• Able to communicate effectively at all levels and present complex and / or new ideas with clarity and simplicity.
• Ability to prioritize concurrent projects with tight deadlines and operate in a highly compliance-driven environment.
• Excellent written, verbal, and interpersonal skills, and the ability to communicate at all levels within the company.
• Travel (25-40%) may be required to represent the company at medical conferences, presentations, and other meetings.

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