Director/Senior Director, CMC Program Management

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Job description

Job Title:

Director/Senior Director, CMC Program Management

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA:

Full time

Exempt

Department:

Portfolio Strategy & Program Management

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 and engage with us on LinkedIn and Twitter .

The Opportunity

The Director / Senior Director will provide leadership and operational support to the CMC Program Management team. The individual will drive effective execution of CMC deliverables by the project teams in coordination with and support of program and corporate goals. The ideal candidate is highly organized, an exceptional communicator and has experience leading teams through late-stage CMC validation and launch activities.

What You Will Contribute

• Drive strategic planning, execution, and implementation of CMC program plans from process development to commercial launch in collaboration with CMC Leadership and cross-functional teams
• Coordinate CMC validation activities across late-stage programs, partnering with CMC Lead PMs and cross-functional subject matter experts (SMEs) to ensure timely and successful BLA applications and launches
• Monitor and report on validation / BLA preparedness, including preparation of phase gate packages
• Establish strong relationships with internal and external/vendor partners to build high-performing teams that will create efficiencies and resolve challenges to achieve ambitious goals
• Lead matrix teams in a regulated GMP environment, partnering with Quality and Regulatory colleagues to ensure the products meet quality and safety specifications
• Establish risk management plans for CMC programs by proactively identifying risks, developing strategies to address them appropriately, and driving the teams to overcome issues and challenges
• Build and monitor fully integrated project schedules capturing all manufacturing activities and resources needed in accordance with corporate goals, scope, budget, and risks
• Partner with PM and CMC Leadership to mentor and develop a high-performing team of program managers, fostering a culture of collaboration, accountability, and innovation
• Implement new processes and process improvement initiatives designed to improve the efficiency and effectiveness of the Program Management function

What We Seek

• Advanced degree in Life Sciences or a related field (MS or PhD preferred)
• Minimum of 10 years of experience in the biotechnology or pharmaceutical industry, with at least 5 years in a leadership role in CMC program management
• Strong leadership, communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels
• Expertise in risk management, resource allocation, and performance monitoring
• Proven track record of contributing to successful product regulatory approval, launches in the biotech/pharma industry
• Strong understanding of drug development, including in-depth knowledge of CMC functions and the strategic and operational requirements from IND to commercial launch
• Project management skills, along with problem solving, negotiation skills, conflict resolution, influencing skills, and team building skills
• Technical proficiency with project management tools; strong computer skills and experience with software such as MS Project, Smartsheet, Excel and SharePoint
• Self-directed, accomplishment-driven individual with a strong sense of passion and urgency who can work both independently and in cross-functional team environments

Preferred Skills

• A background in rare diseases, oligonucleotide or biologics therapeutics
• Project Management Professional (PMP) or similar certification
• Strong analytical skills with the ability to leverage data for strategic decision-making

What We will Provide to You:

• The base salary range for this role is $210,000 - $260,000. 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.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

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