What are the responsibilities and job description for the Global Medical Director, FSHD position at Exokeryx?

Job Title : Global Medical Director, FSHD

Location : Remote

Position type : Full time

FLSA : Exempt

Department : Medical Affairs

Finance ID : 8200-Q224-7

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. 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 searching for a highly motivated and experienced individual for the position of Global Medical Director to lead our FSHD program. This individual will develop and implement the strategic / tactical medical plan for the FSHD program. This role will be responsible for leading an integrated evidence generation plan (registries, IIS), partnering with Avidity’s HEOR team, required to meet unmet needs and inform physicians and patients of real-world evidence as well as deliver foundational materials, training, and programs to move the scientific understanding of our FSHD developmental compound forward. Cross-functional partnerships across the organization will be key. This will include clinical development, medical communications, regulatory, operations, market access, program management, and marketing with the goal of providing medical leadership in delivering therapeutic initiatives in FSHD. This position will also be a key member of the cross-functional program teams.

What You Will Contribute

Fosters collaboration with Senior Leadership to inform and understand corporate strategy and ensure alignment of Global Medical Affairs strategic plan specific to FSHD.
Develop an integrated global medical affairs strategy to drive tactical planning across medical affairs and ensure alignment and collaboration across regional and therapeutic area plans.
Lead and facilitate phase 4 and real-world evidence generation efforts.
Member of MRC and PMRC responsible for working with internal stakeholders at the initiation, creation, and review of educational and promotional materials. Provide medical expertise in the review and approval of external resources, communication, and publications to ensure medical accuracy, objectivity, and fair balance.
Work closely with clinical trial teams to support clinical trial site recruitment and patient enrollment.
Participate as a key member of cross-functional neuromuscular programs team(s).
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 the 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.
Manage and regularly meet with a thought leader network to support the successful execution of Medical Affairs tactics.
Represent Avidity at various scientific and clinical congress meetings.
Play a lead role in providing strategic medical / scientific direction across the company portfolio.
In collaboration with the program teams and publications lead, support the development of the global publication plan and contribute to developing key publications (abstracts, manuscripts, posters, presentations, etc.).
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 plan for pre-launch and marketed products.
Collaborate with Legal / Compliance and Regulatory Affairs and ensure understanding and adherence to external policies and regulations.
Be a key medical support point of contact for major commercial activities in the 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.
Perform all duties in full compliance with company policies and governing law.
Enhance organizational collaboration by encouraging dialog amongst team members to address issues and actively seek solutions that improve the organization at the regional and national levels.
Maintain a positive attitude, anticipate and proactively adapt actions to seize opportunities during times of rapid change and / or uncertainty. Helps others during change through a positive, solution-oriented approach.

What We Seek

PharmD, PhD, or MD with experience in global medical affairs strategy and product launches, including pre-launch preparations.

Minimum of 10 years of industry experience required.

Experience in rare disease or specialty indications is required.

Proven leadership and influence skills, with a passion for working within teams in a matrix organization.

Experience working with management and key business stakeholders to achieve results and influence positive outcomes.

Strong communication skills, with the ability to simplify complex scientific topics for diverse audiences.

Excellent analytical thinking and problem-solving abilities, with a proven track record of collaboration and adaptability in a fast-paced, changing environment.

Ability to manage multiple complex projects in parallel, structuring actions toward shared outcomes.

Collaborative team player with a solution-oriented, customer-service approach and attention to detail.

Capable of working independently and within multidisciplinary teams, including external partners and vendors.

Strong understanding of the industry, Avidity’s value proposition, competitors, and marketplace 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 $280,250 to $309,750. 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 include 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.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA 92121

O : 858-401-7900

F : 858-401-7901

J-18808-Ljbffr

Salary : $280,250 - $309,750

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