What are the responsibilities and job description for the Executive Director, Clinical Development Neurology position at Ionis?

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We are building on our rich history, and believe our greatest achievements are ahead of us. We invite you to apply and join us if you're passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization. Experience and contribute to our unique culture while you develop and expand your career!

EXECUTIVE DIRECTOR, CLINICAL DEVELOPMENT NEUROLOGY

The Executive Director provides leadership and involvement in two or more Clinical Project Teams to ensure the successful design and implementation of Development Plans. Major areas of responsibility include integrated development planning, clinical trial design and execution, clinical data analysis, internal and external communication, and contributions to regulatory submissions, publications, and presentations.

This is a new position in the Neurology Clinical Development group and not the result of attrition which is remarkably low in this group. The key focus of this position will be in the neurology therapeutic area, including neuromuscular diseases and rare pediatric neurogenetic disorders. This position can be fully onsite, remote or hybrid. For remote working the expectation includes visits to Carlsbad, HQ with an approximate quarterly cadence.

RESPONSIBILITIES :

This role will assume management responsibility of teams implementing Phase 3 programs in a genetic form of ALS and in a rare pediatric neurodevelopment disorder. There is additional key responsibility for helping to build and lead a team to develop a neuromuscular disease asset. Ionis likely has best-in-class technology in the neuromuscular disease space, and it is likely that subject matter expert contributions will be needed from program development initiatives across several neuromuscular disorders.
Interact with external medical / scientific advisors, thought leaders and clinical investigators in the therapeutic area and with internal stakeholders across Research, Development and Commercial to prepare / revise / maintain and efficiently execute Integrated Development Plans. In addition to the vision and strategy, this includes proactively working with others to fill clinical development pathway gaps such as biomarker and natural history study needs
Listening and considering the input of relevant stakeholders to appropriately framed questions, and then making critical strategic decisions if you are the decision-maker
Interacting with regulatory agencies, in concert with the Regulatory colleagues, to design and develop novel and efficient clinical programs
Medical writing contributions and review of protocols and other critical study documents (e.g., Integrated Development Plan, Investigator Brochures, IND submissions, Clinical Study Reports etc.)
Maintaining medical / scientific standards, educating team members & managing external Medical / Scientific advisory input into programs
Ensuring action-oriented meetings including setting appropriate agendas and approving actionable minutes
Identifying emerging risks and managing them with the Project Manager and team functions as appropriate
Involvement in high quality presentations to management (and other oversight) committee meetings, including Development Management Committee (DMC), Research Management Committee (RMC), and to corporate partners, investors and clinical investigators as required
Developing and overseeing the project budget with the Project Manager and Development Controller
Clinical study data review and performing analyses in conjunction with Biometrics
Mentor the Clinical Scientist and Project Manager and provide clinical education support for internal company customers
Facilitate, assist and / or participate in the preparation of clinical study manuscripts by Investigators, internal personnel, and / or contract writers
Maintain clinical and technical expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings and partner with company medical, research and commercial teams

REQUIREMENTS :

Desire to build a world-class organization through a combination of vision, energy, drive, enthusiasm, and flexibility

A strong entrepreneurial dimension is required. It is imperative that this individual operate successfully both at a strategic level as well as in a more operational, hands-on capacity. The latter requires a practical, can-do and time-conscious approach that is motivated by the need to do the things today that strategic plans indicate will get a transformative treatment to patients with high unmet need tomorrow

An MD with ~5 years in the industry; strong leadership skills with proven biopharmaceutical industry experience in leading clinical development for early- to late-stage therapeutic programs; and experience in rare neurologic and / or neuromuscular diseases is preferred. Demonstrated success in leading clinical development in both big and small companies is ideal, as is leadership across more than one program simultaneously.

A strong understanding of clinical trial design, particularly adaptive designs. A thorough understanding of the full range of preclinical and clinical development processes through early to mid-stage drug development would be a particularly good fit for this role.

Record of accomplishment including developing, planning, designing, and executing clinical studies leading to the successful registration of therapeutics is also highly desirable.

Experience in regulatory submissions, including interaction with these agencies on novel trial designs and new indications.

Demonstrated use of a variety of regulatory mechanisms (e.g. orphan drug designation, break-through designation, adaptive trials, etc) is desired.

Highly developed understanding of the external marketplace and scientific literature to identify long-term benefits for unmet patients' needs. A scientific background in addition to MD training, with preference for the fields of neuromuscular and / or rare neurogenetic disease would be a significant advantage to design the development of assets in Ionis's current neurology research and preclinical portfolio.

Strong acumen and credibility within the international medical and scientific community resulting from a strong background in medical research, publications and / or patient care. Solid personal and professional relationships with key opinion leaders in neuromuscular diseases are desirable.

Experience working with external partners is a plus

Elevated interpersonal and communication skills with ability to flexibly relate and provide guidance to both internal and external stakeholders. Ability to develop strong positive relationships with colleagues in core teams from Development (clinical science, clinical operations, biomarkers, toxicokinetics, regulatory, medical affairs), Research, Commercial (health economics and outcomes research, market access) and in senior management.

Ability to thrive in an innovative environment while remaining flexible, proactive, resourceful and efficiently getting the work done

A proactive and organized ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations. Also, an ability to identify, synthesize and act upon strategic information and changes within the environment

Attention to detail and quality while also being aware of the need to make timely decisions and execute

Able, when appropriate, to challenge the status quo - and always advocate for the right thing to do versus consensus or the opinion of the most senior leader in the room

Willingness to participate in interrogative debate around issues

Please visit our website, http : / / www.ionis.com , for more information about Ionis and to apply for this position; reference requisition #IONIS003454

Ionis offers an excellent benefits package! Follow this link for more details : Ionis Benefits

Full Benefits Link : https : / / www.ionis.com / careers / working-at-ionis / # : ~ : text=to Applicants »-,Benefits,-Employees are rewarded

The pay scale for this position is $281,860 to $373,404

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Salary : $281,860 - $373,404

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