Medical Director, Medical Affairs

Location
San Diego, CA, United States
Posted
Dec 22, 2020
Ref
oKrgefwp
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Company Overview

Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

Position Overview

The Medical Director will provide strategic direction and medical/scientific leadership and will be responsible for developing, implementing, guiding, and communicating Avidity's Medical Affairs strategy and activities. This role will have patients' interests as a primary mission and in partnership with other Medical Affairs functions, lead the development of medical affairs strategies related to medical and scientific operations, medical expert engagement, medical affairs studies, investigator-initiated research programs, third party collaborative research, and any new product launches. This role will partner cross-functionally with Research, Clinical Development, Communications, HEOR, and Patient Advocacy to plan out the short and long-term strategy for the business in the US. This role will provide medical subject matter expertise in support of Avidity's pipeline and medical input into medical/clinical due diligence activities in support of BD&L. Additionally, this role will support an excellence-oriented and customer-focused culture, fostering enterprise leadership, innovation, cross-functional collaboration and teamwork. The position will report to the VP of Medical Affairs

Responsibilities

  • Develop and Lead scientific/medical evidence generation including RWE, PRO, IST strategy, & post-marketing surveillance
  • Partner with HEOR lead to drive HEOR strategy and execution
  • Provide direction and input into the development of key external stakeholder identification and engagement plan, in collaboration with field medical affairs teams and other relevant CDMA stakeholders.
  • Drive the development of the engagement strategy for key internal and external stakeholders
  • Develop the medical affairs strategy in preparation for the launch of the pipeline assets; ensure support of the brand strategy.
  • Establish and maintain strong working relationships with key external stakeholders (medical experts, medical societies and managed care organization clinical/medical stakeholders) within the therapeutic area; foster effective and compliant working relationships and collaborations between Avidity and key external stakeholders; ensure alignment and collaboration with other customer-facing CDMA teams.
  • Oversee the planning and implementation of external sounding boards, including Scientific Advisory Boards and Steering Committees; create, channel and focus the work product of external sounding boards.
  • Support, iterate and innovate a medical communication strategy which appropriately presents the value of products and science.
  • Ensure integration and optimization of the communication strategy at the portfolio level. Execute the communications plan supporting the scientific needs and core strategy (i.e. planning for medical society presence, abstracts, and publications, supporting CME, writing of abstracts/publications, as appropriate and required).
  • Provide strategic medical and scientific input and day-to-day advice to the organization..
  • Maintain clinical, scientific, and technical expertise in relevant disease states/therapeutic areas
  • Ensure operational efficiency and effectiveness of all aspects of the business function. Manage budget to prioritize highest impact opportunities.
  • Drive the therapeutic area growth agenda by focusing and aligning resources with key priorities in the US with other functions and Corporate/Headquarters groups.
  • Provide strategic input and medical due diligence to BD&L activities where needed.
  • In collaboration and alignment with field medical leadership, drive the activities and field tactical plan of the Medical Science Liaison (MSL) team
  • Gather clinical and scientific insight for current and future products through the attendance at scientific, technical, and regulatory meetings.
  • Provide medical input to drive budget management pertaining to clinical grants and medical education support activities
  • Analyze the competitive landscape as it pertains to regulatory affairs, clinical development plans, healthcare systems, and life cycle management to develop robust strategic plans
  • Provide input and support to scientific communication planning and execution
  • Oversee the build-out of the Medical Affairs team as needed
  • Cultivate an inclusive, high performing environment that values and leverages diversity of thinking, style and experiences.
  • Guide/oversee the medical and scientific training of internal staff (Medical Science Liaisons, Sales, and medical information staff) on products and disease-related aspects.

Qualifications
  • MD/DO, board certification in relevant therapeutic area preferred
  • 7+ years of pharmaceutical industry experience
  • Experience in the design and implementation of medical affairs studies and robust medical affairs strategies
  • Strong background rare diseases and/or neuroscience
  • Previous experience in a clinical practice in relevant therapeutic area preferred
  • Experience leading late stage and post-market medical affairs initiatives
  • Experience presenting scientific information to key stakeholders
  • Demonstrated ability to incorporate external intelligence and insights into the medical affairs strategy
  • Demonstrated ability to direct the activities of a medical affairs team supporting assigned therapeutic areas
  • Demonstrated ability to managing the ongoing medical strategy and to engage managed markets stakeholders, key opinion leaders, and other key stakeholders to share accurate, balanced, and evidence-based medical information