What are the responsibilities and job description for the Executive Director, Clinical Development position at Initial Therapeutics, Inc.?

Job Title :

Executive Director, Clinical Development

Location :

San Diego, CA / Hybrid / Remote

Position type : Full time

FLSA : Exempt

Department : Clinical Development

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

This position will serve as the Clinical Development Lead for one or more of Avidity’s clinical programs. The role will be responsible for leading the design and successful implementation of clinical trials, will be a key member on the program core team and will lead the cross-functional development subteam. Responsibilities include driving development of strategies to identify, monitor and mitigate program level issues and risks that affect execution of the clinical development plan (CDP) and for ensuring timely communication across lines and functions. The Clinical Development Lead will be responsible for leading the design of clinical trials and the development of protocols to meet the CDP objectives and for contributing to key regulatory documents and study level documents including the review and dissemination of study results and related publications. Will also provide oversight of medical monitoring on the program.

What You Will Contribute

Work with key internal and external stakeholders to lead the design and implementation of the CDP and the design of clinical trials to meet the objectives of the CDP
Partner closely with Global Program Head; be a member of the core team responsible for overall program oversight including strategy, launch readiness, and life-cycle management.
Lead the cross-functional development subteam implementing and overseeing phase 3 clinical trials for the FSHD program; develop strategies to identify, monitor and resolve program issues and risks.
Communicate across lines and functions to facilitate timely and effective decision-making and identify key questions to ensure robust assessments.
Communicate to management and relevant functions any potential issues or risks (e.g., changes or significant risks to the CDP, new safety concerns) in a timely manner.
Provide scientific and medical input and strategy for regulatory document creation (briefing documents, IND, NDAs) and participate in regulatory interactions.
Develop or oversee the development of clinical trial protocols and protocol amendments.
Provide medical oversight of clinical studies and provide medical input and guidance on safety monitoring issues.
Contribute to study documents to include Investigator Brochure, Data Monitoring Committee charters, clinical study reports, informed consent forms, statistical analysis plans, study manuals and publications associated with the clinical trials.
Review, monitor, and interpret safety and efficacy data within clinical program.
Set strategy for Advisory Boards and build strong relationships with KOLs and patient advocacy groups; make scientific presentations at advisory boards, key scientific meetings and external committee meetings.
Responsible for interaction and management of the Independent Data Monitoring Committee (IDMC) serving as the key sponsor contact.
Support and mentor clinical scientists, medical monitors and study clinical leads; may have direct line reporting responsibilities.
Maintain scientific knowledge in relevant therapeutic disease areas.
Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements.

What We Seek

Doctorate degree (PhD, MD or PharmD) required

8 years’ experience of relevant pharmaceutical / biotechnology industry with five or more years of direct experience leading global clinical development programs from Phase 1-3.

Rare disease and / or neuromuscular experience required

Strong leadership skills and ability to influence and collaborate with peers and team members without direct line management.

Experience with late stage development and NDA a plus.

In depth knowledge of drug development process and oversight of clinical trials

Experience leading clinical sections of regulatory documents and attend meetings with FDA and EMA.

Demonstrated ability to make significant decisions and recommendations and persuasively present data and support materials to gain approval and sponsorship for projects from senior management.

Experience optimizing extensive knowledge of the clinical development process and strong relationships with team members, colleagues, and internal and external stakeholders to achieve results.

Excellent communication (oral and written), analytical, organizational, and project management skills.

Ability to develop and maintain strong, collaborative relationships with key internal and external stakeholders.

Ability to multi-task well, to deal well with conflict and obstacles, and to work in a fast-paced environment.

What We will Provide to You :

The base salary range for this role is $278,000 - $386,000. 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

O : 858-401-7900

F : 858-401-7901

J-18808-Ljbffr

Salary : $278,000 - $386,000

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