Job Scope & Purpose:
Our early phase, Boston Biotech client is seeking a rare-disease focused clinical development professional dedicated to improving patient lives. The Head of Clinical Development will participate as a critical partner of the leadership team with responsibility for the creation and implementation of clinical and research strategies to support development programs (pre-IND through Phase 1-3 clinical trials, and NDA/launch) in the field of rare diseases. We are searching for a talented, highly motivated, experienced, creative, resourceful, integrative pharmaceutical physician for a highly-visible role that is responsible for leading the creation and ongoing management of the Clinical Research function to support development and future commercial programs worldwide.
This role will be responsible for leading the development and implementation of innovative study design and analysis strategies that will optimize the drug development programs in terms of time, risk and cost. As a senior member of the leadership team, this individual will provide clinical input and medical expertise for development plans as well as for regulatory submissions and interactions with regulatory agencies. The incumbent will drive the design, planning, and implementation of clinical programs and study protocols for drugs that are in all phases of development, and will play a key role in supporting related regulatory activities. This clinical development expert will also support attainment of corporate strategic objectives by contributing their clinical, scientific and development expertise to business development initiatives, co-development partnerships, and development plans for pre-clinical programs. This position will report to the Chief Executive Officer.
Primary Job Responsibilities:
Oversee Clinical Research function in a hands-on capacity, with an innovative approach to protocol design strategy
Partner with senior company leadership on creation of corporate-wide strategies for success in documents such as Target Product Profiles, Clinical Development Plans, Risk Management Plans, Briefing Books, etc.
Create and direct the development of clinical strategies for individual study design as well as clinical development plans with emphasis on innovative strategies to optimize product development and regulatory approval.
Provide clinical review and approval of documents including protocols, SOPs, table/listing/figures, clinical study reports, briefing books, INDs, annual reports, meeting requests, etc.
Play key role in review, interpretation and communication of clinical trial data in regulatory documents and peer-reviewed abstracts, presentations, and publications.
Provide authoritative clinical leadership in preparation for and interactions with Regulatory Authorities, and clinical feedback to questions arising from regulatory agencies.
Establish strong Clinical Advisory Groups of external thought leaders to support the development of compelling clinical development strategies and help optimize program plans and protocols.
Lead clinical discussions with external opinion leaders and counterparts at regulatory agencies.
Support pre-clinical development planning and translational medicine efforts to effectively advance pipeline programs.
Provide clinical, scientific and development expertise to business development initiatives as needed.
Primary Job Requirements:
Medical expertise in internal medicine (specialty training board certification, eligibility or certification in subspecialty of medicine – protein therapeutics and dermatologic experience preferred but not required).
Minimum of 10 years in clinical and drug development in the pharmaceutical/biotech industry including regulatory submission/approval experience.
Minimum of 5 years of supervisory experience in a leadership positon within Clinical Research.
Demonstrated ability to lead by example, and demonstrated skill for technical leadership.
Previous participation in meetings with FDA and other regulatory agencies (e.g., Pre-IND, End of Phase 2, Pre-NDA, Advisory Committee).
Strong understanding of drug development from pre-IND through NDA.
Strong knowledge on the creation of protocols, clinical development plans, clinical study reports, integrated summaries of efficacy/safety.
Excellent ability to lead and work in cross-functional teams with a collaborative style that builds alliances and emphasizes integrity, results, collegiality and effective teamwork in a fast-paced and changing environment.
Experience in translational medicine and in rare disease and orphan indications preferred, but not required.
Understands the scope and focus of phase 1-3 clinical trials and has a proven ability to perform the tasks, manage vendor resources and timelines.
Persuasive, effective and flexible in personal interactions at all levels, with strong verbal and written communication skills
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Displays sense of urgency, and a willingness to be a “player/coach” able to roll up sleeves to get the work done when necessary
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Experience working with all levels of management and consulting with key business stakeholders with an ability to influence for greater outcomes.
Strong team player that has a customer service approach and is solution oriented.
Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
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