Head of Medical Affairs

Company Profile

We are Rakuten Aspyrian Inc., a privately funded, clinical stage, Biotechnology Company headquartered in San Diego, California. We are focused on advancing innovative science into breakthrough products that provide cancer patients with new treatments to conquer their disease.

We are supported by investors that have the commitment to build a long-term company that integrates research, development and commercialization of cutting edge cancer therapies with the aim to transform cancer treatments. Our mission is “CONQUERING Cancer. For LIFE.”

We are developing therapies based on a novel proprietary technology platform that utilizes antibodies conjugated with payloads that are specifically activated at the tumor site. Our first clinical product will advance into Phase 3 pivotal clinical testing to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer. Given the rapid progression of the clinical studies we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.

Position Summary

The Head of Medical Affairs will be responsible for building a Medical Affairs department in a growing organization, leading medical strategy and execution, launch preparations and all aspects of Aspyrian's pipeline. This individual will report to the CEO and work closely with our global clinical team, R&D, commercial/sales, regulatory and other teams to prepare for the launch of our lead products. This leader will be responsible for providing medical insight, guidance, strategy, compliance and training internally and externally, among other leadership roles. He or she will provide critical medical practice insights to drive the late stage clinical development, HEOR, publications, marketing, market access, interaction with patient organizations and other stakeholders to ensure alignment of US and global medical strategies.

Key Duties and Responsibilities

Organizational Leadership/Launch Preparations

Report to the CEO
Serve as a key executive leader of the organization to execute the vision and mission of the company
Build and lead the Medical Affairs organization
Represent the Medical Affairs function to the Board and external organizations
Responsible and accountable for the formulation and the management of the medical affairs budget and timelines
Collaborate closely with cross-functional teams to develop and execute strategies to enhance disease awareness
Work closely with external thought leaders and internal stakeholders to support development of our pipeline. Lead efforts to support inclusion of the key areas of scientific consensus in national diagnostic and/or treatment guidelines as appropriate.
Lead the development of medical information plan and infrastructure in conjunction with Pharmacovigilance and other key functions.
In collaboration with Legal and other functions, review & develop departmental policies, SOPs related to compliance and oversee execution/adherence to process and compliance policies.
Review and approve external communication documents, including medical, scientific and promotional materials.
Build and develop internal training program for medical & commercial team members and other stakeholders.
Implement measurable policies regarding customer and product medical education within the team to assure a high level of customer satisfaction and compliance.

Scientific Communications, Internal and External Collaborations

Lead global scientific communications strategy and collaborate on execution of abstracts and publications
Oversee a field-based medical science liaison (MSL) team that will grow and manage a thought leader network to support successful implementation of medical affairs plans. Support efforts to expand KOL identification and outreach in key therapeutic areas beyond existing/known Centers of Excellence.
Establish and lead national and regional advisory boards to drive better understanding of key strategic evidence gaps, drive lifecycle strategy, develop disease awareness initiatives and patient engagement programs
Develop value propositions and lead preparations for formulary/managed access presentations for Aspyrian's products.
Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc. and shares the information with appropriate parties.
Ensure appropriate review and approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs.

Data Generation, HEOR, Compassionate Use & other Clinical Program Leadership

Lead strategy and execute internal/external collaborations in outcomes, research, cross-sectional analyses and other HEOR initiatives as needed.
Compliantly communicate and interact with patient interest groups and other relevant stakeholders in support of providing access to Aspyrian's products through compassionate use and expanded access programs.
Participate in the global team to evaluate potential proposed research concepts and protocols for investigator-initiated studies (IIT), assessing such IITs for medical/scientific merit, appropriate design and strategic fit with development and product life cycle plans.
Work closely with commercial/market access team to develop compelling medical evidence to support optimal patient access to our medicines.
Provide input into global phase 3b/4 studies and other aspects of the development program, regulatory documents or other clinical program activities as related to US objectives and medical strategy

Desired Education, Skills and Experience

MD or DO degree (PhD or PharmD with specific, relevant experience will also be considered)
At least 15 years of relevant academic, industry, and clinical experience with minimum 10 years in Medical Affairs and 3 years in an executive position, e.g. CMA, SVP or similar
Previous relevant experience with product launches in oncology is required
Post marketing medical affairs and late-stage clinical development experience in oncology is a plus
Experience in a growing biotechnology company as it transitions into commercial launch is highly preferred
Experience in leadership, design, or conduct of observational studies/registries and outcomes research is desirable
Ability to progressively build, lead, and manage a growing global medical affairs department, with performance and budget accountability
Ability to work effectively with commercial and R&D organizations, with a constructive, solution-oriented approach to bridge medical and commercial strategies
Entrepreneurial and strategic vision
Excellent written and verbal communication skills as evidenced by a record of publications
A solid understanding of clinical study designs, including analysis and interpretation of preclinical, clinical and observational data
Understanding of FDA, OIG, HIPAA and other ethical, legal and compliance guidelines relevant to the US and global territories, to ensure team compliance with these external as well as building internal guidelines and optimize existing standard operating procedures
Must be able to represent the company when traveling to medical and scientific conferences. Must establish professional relationships with internal and external stakeholders
Strong negotiation and influencing skills
Excellent team player; willingness and ability to fill functional gaps in a small but growing organization
Ability to travel as needed to support global Medical Affairs operations
Excellent emotional Intelligence and sound character.

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Rakuten Aspyrian Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.