Vice President, Head of Medical and Scientific Affairs

Location: United States - Field based

Division: Medical Affairs

Company: Vifor Pharma

Seniority Level: Vice President

About You

Company Background
Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology, and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures, and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); OM Pharma and Vifor Pharma, Inc. (formerly Relypsa, Inc.).

In 2016, Relypsa was acquired by the Vifor Pharma Group (at that time known as Galenica Group), a Switzerland-based, publicly traded pharmaceutical company. On February 1, 2021 Relypsa changed its name to Vifor Pharma, Inc. as the U.S. affiliate for Vifor Pharma.  Located in the San Francisco Bay Area, Vifor Pharma, Inc. currently employs nearly 300 people with recently announced plans to open an east coast office in New Jersey as their U.S. business continues to grow and evolve..  The name change and bi-coastal presence are a natural evolution in expanding the U.S. affiliate’s reach beyond a single product company to becoming an important part of a multinational, multi-billion-dollar company, and aligns with Vifor Pharma’s strategy to become the global leader in three therapeutic areas: Iron Deficiency, Nephrology and Cardio-Renal.

Vifor Pharma, Inc.’s lead product, Veltassa (patiromer), was approved by the FDA in 2015, becoming the first new drug in more than 50 years for people with hyperkalemia (elevated blood potassium levels). The condition is found in people with chronic kidney disease (CKD) or heart failure, as well as those who regularly take medications such as NSAIDs and beta-blockers to manage those diseases; though asymptomatic, hyperkalemia can lead to arrhythmia and sudden death. Controlling excess potassium though dietary management can be challenging because the mineral is found in many foods that make up a healthful diet. Additionally, there are available drugs that will lower elevated potassium levels in case of a life-threatening event, but managing those levels on a daily basis has been more difficult. Veltassa addresses that chronic management problem: patients mix its powdered form with water and ingest it daily; the drug then binds to potassium in the body in exchange for calcium and is excreted from the body through the normal excretion process. Veltassa has been approved for marketing throughout most of Europe, has been outlicensed to Zeria Pharmaceuticals in Japan, and has received a positive recommendation for funding from the UK’s National Institute for Health and Care Excellence (NICE). According to Vifor’s latest financial results, net sales of Veltassa rose more than 46% in 2019, to CHF 132.3 million net, with US net sales of CHF 124.8 million. 

Veltassa is also being studied for additional indications. In May 2019, the company announced the initiation of their global Phase-IIIb DIAMOND study has begun to evaluate the potential of Veltassa to improve outcomes by enabling heart failure (HF) patients, with or without chronic kidney disease (CKD), to be treated with renin-angiotensin-aldosterone system inhibitors (RAASi) therapy in accordance with HF treatment guidelines. The DIAMOND study is a global, multicenter, double-blind, placebo-controlled trial aiming to study approximately 2,400 patients in over 400 sites. The primary endpoint of the study is the time to first occurrence of cardiovascular death or cardiovascular hospitalization. Top-line results are expected in 2022.  

Additionally, in October 2020, Vifor Pharma signed a license agreement with Cara Therapeutics for U.S. commercialization of Cara’s Phase III injectable drug Korsuva (difelikefalin), which treats chronic kidney disease-associated pruritus (CKD-aP). Under this profit-sharing arrangement, Korsuva will become available to the entire dialysis segment, including clinics that are not part of Vifor’s Fresenius Medical Care system, representing approximately 66% of the U.S. dialysis market. In the longer term, Korsuva will increase Vifor’s market position and deep expertise in the nephrology space. Cara expects to submit an NDA for Korsuva to the U.S. Food and Drug Administration in Q4 2020.

Job Purpose
The Vice President, Head of Medical and Scientific Affairs (“VP, Medical Affairs”) is a key leadership role at Vifor Pharma, Inc. as the company continues to grow and advance its scientific platform. The VP, Medical Affairs will be pivotal to Vifor Pharma commercial success and achievement of its mission to become a fully integrated, multi-product pharmaceutical company that transforms the lives of chronic kidney disease and heart failure patients and their families. This role will be responsible for developing an integrated medical/scientific strategy, including scientific evidence generation and scientific information communication with all key stakeholders. S/he will partner with Clinical Development and Commercial to maximize the value proposition, and externally with key opinion leaders, healthcare professionals, and payors to optimize patient care and treatment outcomes through compliant, evidence-based decisions. The VP, Medical Affairs will serve on the US Leadership Team, the global Senior Leadership Team, and the Medical Affairs Leadership Team.

Key Accountabilities
- Take full ownership to shape and lead the company’s medical affairs organization to achieve corporate goals and objectives while keeping in compliance with applicable policies and regulations.
- Partner and participate with Vifor Global Medical Affairs to set company medical strategy, planning and tactics.
- Establish professional relationships with the medical community and exchange scientific knowledge with global and regional key opinion leaders to identify current and future business opportunities and emerging medical and healthcare practices.
- Champion and lead the development of Medical & Scientific Affairs (MSA) and associated activities including publication planning, medical advisory boards, educational programs, conferences, and responding to requests for medical information. 
- Lead the development, implementation and analysis of Phase IV studies and programs, and execute lifecycle management plans. 
- Assist in the US implementation and execution of the global DIAMOND outcomes trial. 
- Develop Investigator Initiated Study strategy, processes and approval, in alignment with brand strategies and global medical platform. 
- Design and/or implement a process for responding to external requests for information regarding compounds in development and approved products. 
- Collaborate internally with clinical and regulatory departments to support the planning, execution, and management of clinical trial activities. Support registrational studies through site identification, patient identification, and clinical trial recruitment initiatives.
- Partner with Marketing/Commercial to ensure timely, accurate, and compliant preparation and review of promotional an educational material.
- Work closely with Clinical Development and Operations to ensure appropriate institutions and academic centers have opportunities to participate in clinical programs. 
- Oversee speaker programs on disease state, current therapeutics and patient care gaps.
- Develop and implement methods and procedures for developing scientific presentations to individuals and groups of strategic importance to Vifor Pharma, Inc.
- Represent Vifor Pharma and present data at advisory boards, including the Global Hyperkalemia Council, clinical investigator meetings, congresses, etc.
- Establish and execute a strategic publication and congress plan; work with internal team to develop key messages on disease state, mechanism of action, target product profile, molecular diagnosis, etc.
- Remain on the forefront of the relevant science and competitive landscape; evaluate the health economics landscape in each disease area and establish an outcomes research plan.
- Oversee the design and implementation of a registry program as applicable. 
- Build, train, and retain a high-performing team of internally- and externally-facing professionals, including MDs, Medical Communications, Medical Education, MSDs and HEOR professionals. 

Size of Team
Direct reports include Medical Director, Nanoscience; Executive Director, Medical Science Team; Executive Director, Medical Affairs; and a Medical Affairs Coordinator. Total function size is approximately 28.

Role Location
The position will be based at Vifor Pharma’s headquarter in Redwood City, California. With a strong outward-facing presence to the US and the global KOL community, the position will require domestic and international travel. 

The successful candidate for this role will demonstrate the following critical competencies:

Functional Skills in Medical Affairs: The ideal candidate will have experience from a breadth of therapeutic areas. S/he will have deep experience in Phase IV clinical trials, real world evidence (RWE) generation, and post-approval medical affairs, as well as strong insight into drug development. In addition, the VP, Medical Affairs will have the ability to critically interpret cutting-edge science, determine the potential impact of new research on medical thinking and practice, and use scientific and clinical data to formulate conceptual frameworks and disease management approaches. This executive will also have a strong focus on compliance with all external and internal guidelines, requirements, and directions. S/he will bring an integrated understanding of the commercial, clinical, and medical aspects of Vifor Pharma’s U.S. business.

Driving results: The successful candidate will be energized by a challenge, setting new goals, and delivering beyond expectations through strong execution. S/he will have a demonstrated track record of successfully driving medical affairs initiatives and partnering effectively with cross-functional teams. This executive will bring solid experience from best-in-class medical affairs functions that optimize the timeliness, cost effectiveness, and results of medical affairs initiatives. S/he will have experience in setting milestones and measures to track progress and holding teams accountable for meeting deadlines, while shifting resources as needed to optimize progress. In addition to strong organizational skills, s/he will have a demonstrated ability to solve problems with innovative solutions and strong decision-making skills.  

Shaping Strategy: The VP, Medical Affairs will have strong strategic orientation as evidenced by good analytical and conceptual ability and a tendency to think beyond one’s own area.  The candidate we seek can clearly articulate medium- to long-term opportunities and threats; can evaluate options; and plans against anticipated trends, taking proactive steps to address them. S/he will be a strategic thinker and a contributor of ideas and solutions who is able to leverage skills to shape thoughts and ideas from others. This medical executive not only understands science from a clinical and commercial perspective, but also has developed strategies to build value from pre-launch disease and treatment awareness initiatives to post-marketing medical programs and lifecycle management. S/he has a track record of making decisions and educated trade-offs to support the overall business strategy while advancing patients’ interests.  

Influencing collaboratively: The VP, Medical Affairs will only be successful if s/he can influence people around her/him, above and below, across functions and cultures, with a high level of emotional intelligence. Critical to success will be the proven ability to effectively engage with key opinion leaders and successfully leverage external partnerships. This executive will be comfortable as the key customer interface for Vifor Pharma, Inc. to the US medical community and will have excellent presentation and communication skills.  S/he will have demonstrated an ability to positively and strategically influence employees at all levels and will have shown an accomplished record of leading cross-functional teams. Furthermore, s/he will have developed strong working relationships with internal teams (e.g., in R&D, Regulatory Affairs, Safety, Commercial, Business Development, etc.), and with key opinion leaders by applying their input to enhance study design and protocols.  

Leading teams: The successful candidate will have strong leadership and managerial skills, along with previous experience managing and motivating teams of scientific/medical staff, including field-based medical and scientific professionals. S/he will be expected to support the professional development of her/his team, emphasizing teaching, training, and thinking critically about the interface between commercial and clinical issues, while aiming to continuously improve the Medical Affairs function. 

Functional Experience - Required
- At least 10 years of industry experience in a global pharmaceutical company
- Experience leading a national Medical Affairs function for a growing organization, including developing and managing regional medical liaisons and other Medical Affairs professionals
- Working knowledge of GCP/ICH/FDA/OPDP requirements, as well as biostatistics, product safety, and regulatory affairs
- Demonstrated track record of effectively influencing with KOLs and key clinicians

Functional Experience - Preferred
- Strong understanding of all phases of product development, including clinical trial design and scientific principles for controlled trials
- In addition to deep US market experience/network, prior experience in a global capacity
- Knowledge of regulatory requirements for NDA submission
- Cardiovascular and/or renal expertise 
- Prior experience in an entrepreneurial, biotech environment

Other Qualifications - Required
- Medical degree
- Ability to travel 50%

About Us

At Vifor Pharma, we use our skills, dedication, and entrepreneurial spirit to offer innovative solutions in iron deficiency, nephrology and cardio-renal therapies, so we can help patients around the world live better, healthier lives. This is why we come to work every day.
Are you empowered to create a better world, and be part of life changing work? As a global pharmaceutical company, we offer the chance to be part of a worldwide team, where passion and commitment are met with opportunities for professional and personal development. Learn more at viforpharma.com/career.

What you can expect of us

As we work to support patients, we also take care for our employees’ professional and personal growth and well-being. We show appreciation and recognition through attractive benefits that will enhance your life, develop you, empower you to grow, and create your own career journey with us.

Including:

  • Open, safe and inclusive culture that fosters creativity and unleashes individual potential, whether in laboratories, manufacturing sites, in the field, or offices
  • Learning opportunities that enhances your skill set focused on business and personal effectiveness, leadership and management skills, and much more
  • Flexible workplace environment, home office opportunities, competitive vacation entitlement
  • Attractive financial participation schemes, adapted regionally, that provide employees with additional security for every life situation, including: Pension plans, participation schemes, and savings plans

Join Vifor Pharma Talent Community

If you find that the role above is not suitable for your experience or career goals, but you want to keep in touch and learn more about Vifor Pharma and future career opportunities, join our Vifor Pharma Talent Community.

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