Director/Senior Director, CMC Program Management
Company: Avidity Biosciences, Inc.
Location: San Diego
Posted on: October 17, 2024
Job Description:
Job Title:Director/Senior Director, CMC Program
ManagementLocation:San Diego, CA / Hybrid / RemotePosition
type:FLSA:Full timeExemptDepartment:Portfolio Strategy & Program
ManagementStrive to Bring a Profound Difference to our PatientsAt
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 and .The OpportunityThe 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
Biosciences10578 Science Center Dr. Suite 125San Diego, CA 92121O:
858-401-7900F: 858-401-7901
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Keywords: Avidity Biosciences, Inc., Temecula , Director/Senior Director, CMC Program Management, Executive , San Diego, California
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