MD, PhD, Pharm D or equivalent ex-US medical degree
5+ years of demonstrated high-level professional knowledge and skills in Medical Affairs and R&D, especially familiarity with early clinical development, in the pharmaceutical or biotech industry.
Deep therapeutic area knowledge and experience in Neurological Diseases.
Extensive knowledge of the latest regulatory, policy, and technology developments preferred.
Experience in global scientific engagement strategy including scientific congresses, external experts and panels, symposia, etc., preferred.
Influential matrix leader who builds relationships across stakeholder types
Leadership presence with the ability to communicate complex data persuasively and relate study results and knowledge of therapeutic area to industry-specific applications Experience with RWE, diagnost
Demonstrated expertise in informing R&D and commercialization strategies including patient pathways and mapping treatment landscape.
Preferred experience in working with Clinical development team and help shape CDP, data interpretation and dissemination.
Experience supporting due diligence for Business Development and serving as a medical expert for integrated asset planning, and building medical assessment framework.
High degree of professionalism, maturity, and confidentiality.
Strong written and verbal communication skills as well as strong leadership and interpersonal skills.
Demonstrated reputation as a well-respected, dynamic team player-coach.
Ability to deliver on company global program goals and objectives as they pertain to Medical Affairs.
Ability to influence positive organizational change at the company and team levels
Full description
The Global Medical Director, Early Assets will report to the VP, Early Assets and will be responsible for developing, leading, and executing the medical strategy and scientific engagement for multiple early-stage CNS clinical programs, including assets being developed for Huntington’s disease, Cerebral Amyloid Angiopathy (CAA) and Alzheimer’s disease. The successful candidate will serve as the primary point of contact for Clinical Development and Value & Pipeline Commercialization teams and be the medical affairs delegate on the Program Team to ensure that the Medical Affairs perspective and the voice of the patient and health care provider are incorporated into early development and commercialization strategies. This is a critical role in driving medical strategy and execution excellence, enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement and product expertise.
Key Responsibilities
Provide strategic and scientific leadership to and define global Medical Affairs strategy for CNS early-stage clinical programs.
Serve as a key member of the product development teams and meaningfully impact clinical development plans, study design, and data interpretation.
Lead and execute global scientific engagement strategy and drive excellence in scientific engagement with all key stakeholders.
Develop, initiate, and maintain strong relationships with international scientific leaders and key stakeholders to enhance awareness of Alnylam’s early asset portfolio.
Organize and manage global expert events (advisory boards, expert panels, symposia). Functions as the scientific medical expert internally and externally with national and international stakeholders.
Serve as a collaborator and key stakeholder in global clinical operations, global commercial development, global market access, global clinical R&D, global pharmacovigilance, and the promotion review committee (PRC) on medical aspects of the company’s products.
Provide strategic medical insights into R&D and commercialization strategies including profiling patient pathways, mapping the treatment landscape, and understanding prescriber patterns and dynamics.
Serve as the Medical Affairs lead for strategic partnerships:
Partner with Value & Evidence Strategy team to develop and execute against integrated evidence generation plans
Partner with the Medical Communications team to ensure the development of global communication, strategy, and execution of timely and high-quality communication of scientific data (publication and medical congress)
Partner with Medical Training team to develop and deliver high quality scientific and skill-based training to medical team across regions
Partner with Omnichannel team to develop a strong Omnichannel prelaunch strategy for successful commercial launch.
Liaise with global and regional Medical Affairs to ensure medical insights from all key markets are integrated into and inform product development.
Oversee development and execution of comprehensive integrated evidence plans (IEP)s ensuring high-quality publications from all types of evidence throughout development, launch, and in-market for all Alnylam pipeline and inline products.
Provide medical expertise and input into TA strategies ensuring close collaboration with R&D to deliver data and a label to support the Target Product Profile (TPP)s and reflect the value required to enable speedy patient access.
Qualifications
MD, PhD, Pharm D or equivalent ex-US medical degree
5+ years of demonstrated high-level professional knowledge and skills in Medical Affairs and R&D, especially familiarity with early clinical development, in the pharmaceutical or biotech industry.
Deep therapeutic area knowledge and experience in Neurological Diseases.
Extensive knowledge of the latest regulatory, policy, and technology developments preferred.
Experience in global scientific engagement strategy including scientific congresses, external experts and panels, symposia, etc., preferred.
Influential matrix leader who builds relationships across stakeholder types
Leadership presence with the ability to communicate complex data persuasively and relate study results and knowledge of therapeutic area to industry-specific applications Experience with RWE, diagnostics, translational work, and digital innovations.
Demonstrated expertise in informing R&D and commercialization strategies including patient pathways and mapping treatment landscape.
Preferred experience in working with Clinical development team and help shape CDP, data interpretation and dissemination.
Experience supporting due diligence for Business Development and serving as a medical expert for integrated asset planning, and building medical assessment framework.
High degree of professionalism, maturity, and confidentiality.
Strong written and verbal communication skills as well as strong leadership and interpersonal skills.
Demonstrated reputation as a well-respected, dynamic team player-coach.
Ability to deliver on company global program goals and objectives as they pertain to Medical Affairs.
Ability to influence positive organizational change at the company and team levels
About Alnylam
We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.
Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.
The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: