||Vice President, Clinical Development
Akcea Therapeutics is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious rare diseases. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical
program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics. Akcea has a portfolio of development-stage drugs covering multiple targets and disease states using advanced
Akcea was established by Ionis Pharmaceuticals in late 2014 and was listed on the NASDAQ stock exchange in July 2017 under the symbol “AKCA.” Akcea is a global company headquartered in Cambridge, MA with offices in Carlsbad, CA and across the EU and Canada.
VP, Clinical Development
The position of VP, Clinical Development is a newly created position within Akcea to lead all clinical development programs and operations within the company and to provide critical support to the strategic development objectives of the Company.
The VP, Clinical Development working closely with and reporting to the Chief Medical Officer (CMO) will be responsible for the leadership and strategic direction of development products and programs across all stages of development at Akcea. These responsibilities
will cover the full scope of clinical development functions from Phase I (including human PK/PD and DDI) studies through Phase II-IV trial design and execution. This position will work closely with the preclinical and clinical development teams ensuring effective
strategy, design, execution and regulatory acceptance of development programs. This position will also provide leadership to the organization, moving compounds into and through the clinical development process. The VP, Clinical Development will provide direct
input into R&D strategy and plans, indication/patient population selection, management processes, resource allocation and management, budgeting, and the evaluation and mitigation of drug development risks. This is a hands-on position that is expected to deliver
top quality development activities in a timely manner.
- Provide robust, innovative, visionary leadership for global clinical development
- Design and oversee clinical trials that meet the standards of excellence for ethics, scientific merit, good clinical practice and regulatory compliance, as well as satisfy corporate goals for approval of products
- Oversee execution of clinical trial protocols, with primary accountability for conduct of assigned trials, including collection and interpretation of data and patient safety information
- Ensure Akcea’ s focus on the patient, their needs and medical excellence is never lost in the design and execution of clinical trials by working closely with Therapeutic Area experts, patient groups and other internal and external stakeholders
- Lead the clinical development teams to ensure all clinical protocols are of the highest quality focusing on clinical, translational and regulatory aspects to enable optimal decision-making
- Select, oversee and coordinate contract research organizations (CROs) and other vendors
- Provide leadership in establishing strategic directions across all therapeutic areas through active participation at senior levels to determine global strategies for products and disease areas
- Ensure that clinical plans are developed to deliver well-designed studies on time, within budget and with full understanding of the risks and opportunities
- Interpret results of clinical investigations in preparation for new drug applications to relevant regulatory authorities and for publication and other forms of dissemination
- Ensure scientifically appropriate data analysis, interpretation, and reporting are prepared and available in a timely manner for clinical sections of key regulatory documents (e.g. IND/NDA, MAA) as well as for other forms of data dissemination (publications,
press releases, conference presentations, etc.)
- Set standards, establish clear expectations, and monitor delivery of excellent performance for all clinical development personnel and activities
- Develop and maintain relationships with KOLs and other key medical experts
- Establish productive, interactive relationships with key internal departments, as well as the medical and scientific community
- Represent Akcea as a senior medical spokesperson before appropriate scientific, medical, regulatory, business and other professional meetings
- Support Business Development in the evaluation of in- and out-licensing opportunities and contribute to the identification of new medical applications and disease indication consistent with Ionis’ and Akcea’s strategic intent
The VP, Clinical Development will be an energetic executive with strong interpersonal skills, comfortably integrating into a senior-level, high profile role within an established and growing team. The successful candidate will be motivated by the opportunity
to be part of a senior management team, efficiently designing and conducting clinical trials that meet regulatory and commercial requirements. The individual who will be effective in this role has established relationships in academia, industry, and with health
authorities and policy makers. A self-motivated, approachable, articulate team player, the VP, Clinical Development will have the highest level of integrity and core value system that is consistent within the Akcea and Ionis cultures.
Specific minimum requirements include:
- 15 or more years of clinical development experience to include ten or more years of significant leadership/management experience in a pharmaceutical or biopharmaceutical company. MD is required and subspecialty certification relevant to the therapeutic
focus of Akcea is strongly preferred
- Demonstrated track record of leading the successful global development of drug candidates through clinical trials leading to product approval. Significant experience in cardiovascular (CV) or lipid clinical development is strongly preferred
- Ability to identify realizable solutions and alleviate potential hurdles in unique clinical trial situations to ensure trial success
- Experience building a global development organization based upon best practices, leading-edge science, and innovation
- Strong knowledge of regulatory (e.g. FDA, EMA) requirements, good clinical practices and pharmaceutical clinical development
- Demonstrated ability to provide strategic direction for programs of broad organizational impact by continually seeking out others across function/organization to provide direction and guidance based upon knowledge of a specific product, therapeutic area,
and/ or the competitive landscape and industry
- Ability to shape major functional/organizational and business decisions, providing novel insights from both a strategic and operational perspective
- An energetic, forward thinking and creative individual who is a team player
- Demonstrated excellence in interpersonal, cross-organizational communication skills with the ability to interact effectively with internal and external constituencies is required.
- Ability to handle ambiguity and uncertainty, make appropriate prioritization decisions, and drive projects to completion
- Results-orientated with a bias to act and an innovative approach to address business challenges
- Excellent judgment and willingness to take prudent risks
Excellent salary and benefits package offered.
For more information on Akcea and to apply for this position, please visit our website: www.akceatx.com
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Akcea Therapeutics, Inc. is proud to be an EEO employer.
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