lavori da Pharma in località Germania

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

As the Medical Affairs Director, this person will be a strategic thought and operational partner providing expert medical leadership and contributing to the development and execution of the Country launch strategy. This person will lead the Germany country launch strategy for Rare Disease, medical affairs content development, KOL engagement planning including educational initiatives, and support our cross-functional teams in Europe, including Value & Access, Commercial, and Patient Advocacy. As a key member of the European Medical team, reporting to Head of Europe, Medical Affairs, this person will be accountable for advancing Scholar Rock's (SRK's) scientific and medical affairs leadership in Rare Neuromuscular Diseases including Spinal Muscular Atrophy and other pipeline indications in Germany. This person will thrive in this role if he/she is a self-starter, a highly collaborative individual, and have a "Will-Do" attitude, who is driven to make a positive impact on patients and their families in this rare disease space.

Position Responsibilities:

• Provide scientific and medical affairs leadership, including development of strategic and tactical country medical affairs (pre-)launch plans, identifying specific unmet medical needs, data gaps, and practice gaps.
• Provide medical and scientific expertise to the Value & Access team to support country pricing and reimbursement, viz. AMNOG etc.
• Drive and manage Early Access Programs or similar initiatives, by providing medical affairs expertise and support, i.e. from project initiation to closure, and maintaining external stakeholder relationships.
• Lead the country medical team including field Medical Science Liaisons.
• Interface, educate, and gain insights from external stakeholders, including government agencies, professional medical societies, guidance committees, key opinion leaders and key decision makers, payor and reimbursement stakeholders, and patient advocacy groups, on issues related to SRK's assets.
• Oversee gathering and reporting field medical insights through existing CRM system and in line with company rules and requirements.
• Organize external expert advisory boards, support scientific symposia, and CME programs.
• Pull through scientific, medical, and clinical insights across different areas to inform the country's cross-functional strategies and tactics, and also vertically to regional and global Medical Affairs.
• Ensure cross-functional collaboration and input from key internal stakeholders to optimally manage these relationships, to ensure aligned and effective execution of the country's medical strategy.
• Lead medical content development, and other high impact strategic activities such as advisory boards, medical education with help of external vendor management to ensure impactful and timely delivery of medical materials and initiatives.
• Provide medical expertise and editorial support in the data dissemination at conferences and in medical journals.
• Oversee medical activities related to review of promotional and scientific materials.
• Collaborate with functional groups as the subject matter expert including Patient Advocacy, Commercial Operations, New Products, and many other internal stakeholders in support of pipeline products and additional indications.
• Provide medical leadership to guide internal and external decision-making.
• Establish and maintain strong knowledge in SMA to optimize clinical study and external research initiative protocols development and execution.
• Assist in publication activities, including review and approval of abstracts and manuscripts, local publication strategy development and collaboration with authors as needed.
• Establish and maintain strong relationships with experts in the field, academics and professionals.
• Ensure a patient-centric approach to development of clinical studies and external research initiatives under your supervision.
• Collaborate cross functionally to execute and/or drive the clinical studies and any external research initiatives under your responsibility in alignment with the Brand plan and Global and/or European Medical Plan.
• Develop and maintain, together with MSLs, close professional relationships with Key Opinion Leaders and emerging scientific leaders in the community.
• Foster strong relationships with internal and external stakeholders to identify unique opportunities to improve and evolve educational and training content.
• Manage budget for assigned projects.
• Accountable to understand HCP needs and to develop and deliver a strategic and tactical medical affairs plan designed to improve patient care and generate evidence of relevance for SMA in Germany.
• Support in country Clinical Trials (CT) enrolment.
• Other duties as assigned.
• Travel required, comprising approximately 20-40%.

• MD, PharmD, PhD, or equivalent scientific degree. MBA desirable.
• Minimum 7 years' experience in industry R&D or Medical Affairs.
• Leadership experience.
• Product Launch experience.
• Rare Disease or Neuromuscular experience is a plus.
• Excellent written and communication skills, highly organized and able to manage supporting multiple initiatives.
• Business fluency in German language; fluency in English.
• Scientific communication and presentation skills with the ability to present scientific data in a credible manner. Able to interface professionally with a wide spectrum of internal and external academicians, in the scientific/medical arena.
• Leadership skills: personal style that includes a sense of urgency, as well as flexibility and ability to respond to rapidly changing environments and circumstances.
• Collaborative and proactive, with a hands-on, roll-up-the sleeves style and attitude.
• Highest integrity; committed to ethics and scientific standards.
• Solid track record of achievement in Medical Affairs in the biotech/pharma industry.
• Ideally have worked in the field of rare diseases; SMA experience would be advantageous.
• Experience in clinical trial design, especially phase IIIb-IV.
• Be equipped to evaluate the pipeline of potential business development opportunities.
• Demonstrated successful partnership with Commercial organization, developed KOL programs and relationships, offered field training, patient outreach programs and the like.
• A curious learner who is focused on patient outcomes and values collaboration and advancing scientific understanding.
• Team player who will proactively bring expertise to other departments as needed.
• Be a critical thinker, able to share fact-based opinions without ego.
• Able to make complex science understandable for a non-scientific audience.
• Have solid business acumen, may have spent time in a commercial role.
• Results-oriented, can embrace a fast-paced "can do" culture.
• Have scope for personal growth and development.
• Respect and humility for internal and external stakeholders.