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Title: Senior Medical Director, Medical Affairs Strategy, Oncology
Reports To: Senior Vice President, Medical Affairs
Location: Redwood City, CA or Remote
Classification: Exempt

Overview:

As part of our expanding Oncology Medical Affairs team, Coherus is seeking a Senior Director, Medical Strategy. This role will report to the SVP, Medical Affairs and will lead medical activities through the successful execution of the oncology medical affairs strategy and tactical plan across Coherus’ portfolio (marketed and investigational products). The position will define the Medical Affairs strategy, develop and advance collaborations with key opinion leaders, provide thought leadership and tactical execution for medical brand plans, publication plans, medical education, medical information, field medical liaisons, and medical communication. You will partner with Commercial, Research and Development, Clinical Development, and Regulatory Affairs. Candidates will leverage advanced medical expertise in partnership with the Medical team on areas spanning external strategy, clinical development, and commercialization. The role provides internal strategy leadership and external ambassadorship for medical science and strategic oncology stakeholders. The Senior Director, Medical Strategy will serve as a key member of the Medical Affairs Leadership Team (MALT) contributing to launch & development efforts, maintaining fiscal responsibility, and advancing innovation.

To be successful in this role, the individual must be self-motivated, proactive, be strategic, possess a hands-on approach, able to work well with cross-functional teams and external collaborators, be able to influence decision-making, and be able to operate within pre-specified timelines and in a fast-paced, high accountability environment. The individual is expected to possess outstanding communication skills (both verbal and written), a strong work ethic, and a high degree of professional integrity.

This role can be remote and will require intermittent travel to our headquarters in Redwood City, California, as well as travel for physician visits and conferences.

Duties and Responsibilities:

• Lead the development and implement the Medical Affairs strategic plan across Coherus’ immuno-oncology portfolio (marketed and investigational products). Measure and assess the effectiveness of the US Medical plans regularly
• Medical Affairs product lifecycle management (including real world evidence strategy) and launch readiness plans
• Lead development and execution of competitive intelligence plan and deliverables
• Develop Investigator Initiated Trials (IIT) strategy including areas of interest and budget. Oversee and serve as Chair and coordinator/administrator of the IIT program, consistently engage with HCPs to understand their evolving medical needs, identify knowledge gaps, and evolve IIT research areas of interest
• Oversee the CME program and serve as the CME program coordinator
• Provide medical expertise and approval of US promotional materials
• Provide medical expertise and approval (if applicable) of non-promotional materials including but not limited to data analytics
• Review and approve all standard and custom Medical Information response letters
• Lead advisory boards in collaboration with Clinical Development to drive input for lifecycle management, HCP education etc.
• Serve as member of the Product Development Team(s)
• Cultivate relationships with diverse external audience including but not limited to medical and scientific experts, clinical researchers, academic institutions, community oncology, and research consortia, to assess unmet medical needs to develop and execute appropriate medical strategy
• Serve as medical expert presenter and educator for internal and external needs (advisory boards, round tables, promotional speaker training, investigator meetings, congress presentation, etc.)
• Contribute to medical communications by authorizing and/or reviewing abstracts, presentations and manuscripts for medical accuracy and content
• Participate in medical and cross-functional strategy meetings and provide medical expertise including the safety review team
• Assess, develop, and execute research collaborations across Coherus portfolio products
• Oversee and execute Medical Affairs sponsored clinical studies including development and review of study protocols
• Develop, refine and implement all required Medical Affairs policies, procedures and SOPs
• Provide Medical expertise to the Commercial organization in a compliant manner as needed to assist in the development and execution of commercial activities
• Provide medical expertise and input for new product licensing and acquisition opportunities and study protocols for clinical collaborations
• Represent Coherus at key medical conferences and external events
• Foster a culture of 100% compliance

Qualifications:

• MD degree and 10+ years broad bio/pharmaceutical industry experience in a pharmaceutical/biotech setting
• 5+ years of proven Medical Affairs leadership, building and implementing a successful Medical Affairs strategy and infrastructure
• Strong analytical and problem-solving skills, with an ability to evaluate scientific data and medical literature and the ability to extrapolate to medical, marketing, or sales programs required
• Understanding of the US Healthcare system, the pharmaceutical industry, and clinical and health economic practices in the US is required
• Strong oral, written, and presentation skills with a thorough understanding of current medical oncology practice and the willingness to learn new areas of oncology
• The successful candidate must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient in that setting. Must excel in a multidisciplinary environment as an integral leader and provide medical science leadership within assigned teams. Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations is essential.
• Excellent and impactful written and verbal communication skills, strong problem-solving ability, and self-motivated. A hands-on approach to performing duties with a strong self-directed work ethic and attention to detail and quality are critical to success
• Executive presence; confident, positive attitude, and enthusiastic.
• Knowledge of multiple therapeutic areas related to Coherus immune-oncology portfolio, as well as proficient experience in oncology and immuno-oncology. Internal medicine and oncology experience/training is preferred.
• Extensive and recent product launch experience in oncology, having successfully launched key products/brands preferred.
• Broad working knowledge of FDA requirements, industry compliance.
• Experience with US market medical promotional review preferred.
• Effective presentation skills to key stakeholders and key decision makers.
• Strong negotiation skills, and must be able to solicit information, persuade others and reach outcomes for overall strategic plan.