Senior Director, DMD, Medical Affairs

Commercial United States


Description

Job Title:
Senior Director, DMD Lead, Medical Affairs, North America
Location:
Remote
Position type:
FLSA:
Full time
Non-Exempt / Exempt
Department:
Medical Affairs
 
Strive to Bring a Profound Difference to our Patients
 
At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. 
 
Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.
 
The Opportunity
 
Avidity Biosciences is looking for a highly motivated and experienced individual for the position of Senior Director, Medical Affairs North America. This individual will report to the Vice President, Medical Affairs North America and provide medical and scientific leadership and expertise in DMD and neuromuscular disorders. This individual will be responsible for developing and implementing the strategic/tactical medical plan that will support clinical development, launch, and lifecycle management for our investigational therapy in DMD. Furthermore, this individual will lead required evidence generation efforts (Registry and IIS) and inform physicians and patients of real-world evidence. This role will also deliver foundational materials, training, and programs to move the scientific understanding of our therapeutic initiatives in DMD. This person will work cross-functionally with clinical development, medical communications, regulatory, operations, program management, and marketing teams. 
 
What You Will Contribute
  • Design and implement North America Medical Affairs strategic plan to support the DMD program.
  • Collaborate with Senior Leadership to inform corporate strategy and ensure alignment of North America Medical Affairs strategic plan.
  • Establish collaborative relationships with academic and industry thought leaders, investigators, advocacy groups, and other external stakeholders.
  • Act as medical affairs lead and key member of one or more cross functional program team(s), as required.
  • Lead and facilitate Ph 4 and real-world evidence generation efforts.
  • Member of MLR and PMLR; work with internal stakeholders at the initiation, creation and review of educational and promotional materials. Provide medical expertise in review and approval of external resources, communication and publications to ensure medical accuracy, objectivity and fairness/balance.
  • Work closely with clinical trial teams to support clinical trial site recruitment and patient enrollment.
  • Plan and execute strategic working group sessions and advisory boards with healthcare providers to collect needed clinical insights to inform medical strategy and tactics.
  • Work with clinical development and HEOR teams to support inclusion of appropriate trial endpoints and outcome measures to inform physicians and payers.
  • Develop foundational materials and support training for regional and medical field teams.
  • Collaborate with the Preclinical, Clinical Development, and Medical Affairs teams to translate clinical insights and data gaps into medical strategy.
  • Ensure alignment of the Medical Affairs activities and tactics with the launch readiness and program management plans and objectives.
  • Provide medical expertise in support of developing content (slides, websites, standard response letters) for medical communications and education to advance disease state and clinical understanding.
  • Represent Avidity at various scientific and clinical congress meetings.
  • Collaborate with thought leaders to develop clinical therapeutic concepts, identify messages for scientific communications based on preclinical or clinical data, and gain feedback on strategies to support medical affairs plans for pre-launch and marketed products.
  • Collaborate with Legal/Compliance and Regulatory affairs and ensure understanding and adherenceto external policies and regulations.
  • Be a key medical support point of contact for major commercial activities in area of responsibility.
  • Demonstrate and apply a deep understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers.
  • Demonstrate, and lead by example, compliant behavior in all aspects of company work.
What We Seek
  • PharmD/PhD/MD with experience leading and building medical affairs strategy including 10+ years of industry experience.
  • Significant experience launching products including pre-launch prep.
  • Experience in rare disease or specialty indications required, experience in neuromuscular disorders/DMD preferred.
  • Flexible, entrepreneurial by nature, a collaborative team player who works well with patients, physicians, providers, payers, regulators, scientists, and peers.
  • Must possess excellent communication skills, including ability to strategically synthesize and simplify complicated scientific topics into understandable messages for broad audiences.
  • Leadership and influence skills, including a passion for working within multiple teams and proven ability to achieve results in a matrix organization.
  • Must be able to actively manage and track many complex projects in parallel, structuring the actions of many people toward shared outcomes.
  • Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in a rapidly growing and changing environment.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to positively influence stakeholders in a team environment for greater outcomes.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Proven track record of excellent communication and collaboration skills, including recognition by cross-functional partners; works well independently while exhibiting professional maturity, confidence, and competence.
  • Outstanding business acumen; knows the industry, Avidity’s value proposition, key competitors, and other marketplace factors/dynamics.
  • Ability to travel extensively and must possess a valid driver’s license. Weekend travel may be required.
What We will Provide to You:
  • The base salary range for this role is $278,900 - $308,300. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
  • Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
  • A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.