- Time Management
- Clinical Trials
- Leadership Experience
Medical Affairs (Lumasiran)
Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition, Alnylam has four investigational medicines in late-stage development. www.alnylam.com. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work in 2015, 2016, and 2017.
The Executive Director role is a leadership position that will help shape and implement the overall Medical Affairs strategic objectives for specific Alnylam disease areas on a global basis with the focus on Hyperoxaluria. Through strategic alignment, the Executive Director will be responsible for execution of activities such as investigator and expert outreach, acceleration of recruitment efforts in company and investigator sponsored trials, facilitation of advisory boards, Continuing Medical Education, grants and sponsorships. As part of execution of the Alnylam strategy, he/she will work closely with Medical Affairs, Clinical Operations, Regulatory, Safety, Program Leadership and Commercial functions. This position will report to the Senior Vice President & Head of Medical Affairs.
The Executive Director will be responsible for building the Hyperoxaluria MSL teams and for developing strategies and tactical execution plans to engage health care professionals, medical organizations and patient advocacy groups. The Executive Director will be well-versed in clinical practice and clinical research so as to deliver cutting edge data and technical/practical education to Health Care Professionals. Working with the Senior Vice President & Head of Medical Affairs, the Executive Director will provide strategic and operational support for executing Medical Affairs goals and objectives. This position will involve cultivating professional relationships as well as oversight and health outcomes initiatives at a global level. The strategic areas of focus include: investigator sponsored studies, health-care and payer decision maker education, and company sponsored clinical trial recruitment.
Regional Medical Leads and MSL Directors will report directly to this position.
Summary of Key Responsibilities
Build and execute strategic initiatives across pipeline programs as they enter both early and later stages of development in conjunction with Clinical Lead and Program General Manager
Lead, communicate and execute the development of an integrated medical affairs plan, including, Medical Liaisons, Health Outcomes, and Clinical Research (natural history studies, registries) for Hyperoxaluria. Foster the establishment and maintenance of key external thought leaders through gaining knowledge on their insights and development of scientific/clinical engagement plans.
Implement strategies to accelerate company sponsored and investigator sponsored studies.
Provide medical leadership for scientific review and approval of communication materials and medical materials in compliance with corporate standards and government/industry regulations.
Lead the review, approval and execution of Investigator Sponsored Trial concepts/protocols.
Represent Alnylam at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with thought leaders.
Facilitate global and national advisory boards to gain insights for the development of innovative therapeutic approaches in Hyperoxaluria.
Provide Medical Affairs support to review requests for grants and sponsorships. Ensure that review and approval processes strictly follow compliance guidelines.
Manage and develop Medical Leads and MSL Regional Directors including hiring, training, evaluation and motivation, in alignment with Alnylam’s corporate values, strategies and objectives.
Provide strong leadership to motivate and achieve outstanding results that align with company and department goals.
Develop and ensure alignment in medical education activities for comprehensive care teams through MSL -delivered presentations, participation in medical, payer and patient meetings, and other appropriate venues to enhance disease state knowledge and value creation.
Actively support the teams within their scope of responsibility by being their advocate and spokesperson; promote sense of urgency and collaboration within the team, across work groups and with clinicians.
Develop and maintain productive and appropriate relationships with individuals across the organization including cross-functional groups.
Ensure that all interactions and activities in the region comply with Alnylam’s guidance’s and policies. Develop innovative approaches to drug development and play a leadership role in regulatory interactions to secure global regulatory approvals
Work with the Clinical Development Leadership Team to build and grow a highly effective development organization
Collaborate closely with Preclinical, Regulatory, Clinical Operations, Biometrics, Medical Affairs and Commercial to ensure tight strategic integration of product development plans
Influence internal and external audiences in a high impact, highly visible fashion
Accountable for progress of projects within his/her sphere of accountability, across a range of disease areas
A highly driven, dynamic, engaged and accomplished Clinical Development physician with late stage development experience and solid leadership experience along with a high EQ will thrive in this role. The individual must be strategic and visionary with strong written and verbal communication skills. The ideal candidate will be a highly innovative, collaborative, scientifically-grounded and an accomplished Medical Affairs physician with a flexible, hands-on and team-oriented style with the ability to think on their feet, be relationship oriented and have an entrepreneurial spirit. Specific qualifications include:
MD with 10+ years of Clinical Development and/or Medical Affairs experience. Previous experience in rare disease therapeutic area is preferred.
Experience leading a phase III program and driving or actively participating in aspects of an NDA/BLA/MAA.
Excellent communication, presentation and time management skills required; must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization.
Able to inspire a team to excel by fostering a climate of energy, excitement and personal accountability.
Demonstrated leadership in ambiguous situations.
Current working knowledge of legal, regulatory, and compliance regulations and guidelines.
Ability to partner with key internal stakeholders to understand Alnylam’s key objectives, and to drive plans that exceed these.
Overnight business travel of up to 50% is required.
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.