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Executive Director, Regulatory Affairs
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening disease. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins of proteins as drug targets.
We are currently seeking a highly experienced, strategic, and influential regulatory leader to develop and optimize Eikon’s emerging Regulatory Affairs and CMC functions.
You are a seasoned and highly effective leader, with deep experience in developing regulatory strategies and their implementation for oncology programs globally. You have a comprehensive understanding of regulatory activities and how they affect projects and processes. You have a passion for setting organizational direction, championing change and continuous improvement, with cultural awareness and sensitivity to achieve results across both regional country and international borders, while enabling the discovery and development of novel classes of drugs.
What You’ll Do
- Provide leadership to the Regulatory Affairs and CMC functions: Build the best team and chart the course. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all functional deliverables.
- Responsible for development and implementation of worldwide regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously for all therapeutic areas.
- Coordinate the preparation, submission and follow-up contact with regulatory agencies and / or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval for all submissions and associated documentation.
- Act as a credible, influential, and respected spokesperson for our company with external organizations through direct communication with the FDA; including telephone calls and e-mail; chair meetings between our company and FDA; prepare our internal teams for meetings with FDA at any phase of drug development.
- Serve as a primary liaison with global regulatory agencies across our portfolio including early drug discovery through to clinical trials and future commercial activities.
- Coordinate interactions with global regulatory agencies to support registrations and interactions and provide strategic direction across multiple regions simultaneously.
- Provide therapeutic area regulatory strategies and disease state insights; regulatory vision and direction to add patient value and product differentiation; recommendations to optimize the portfolio, and leadership to establish an external network to proactively prepare for trends affecting the company.
- Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
- Review and provide final approval worldwide marketing applications, clinical study reports, protocols, investigator brochures before release from our company to external agencies and investigators.
- Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.
- Develop, communicate and maintain project schedules for regulatory filings that are consistent with product development and commercialization plans.
- Participate in regulatory and CMC due diligence activities for licensing candidates in collaboration with business development.
- Contribute to the development of best-in-class processes and SOPs to ensure regulatory compliance.
- Function as the Regulatory CMC lead on projects and submission teams by applying advanced knowledge of regulations and interpret technical regulatory guidelines to ensure that regulatory submissions comply with applicable regulations.
- Identify CMC risk areas and develop alternative courses of actions including anticipation of regulators responses through scenario planning and development of contingency plans.
- Align CMC regulatory strategy to overall regulatory business strategy (e.g., upcoming process, raw material, shelf-life and analytical changes).
- Mentor, train, and manage junior level staff.
- Science degree (PhD, PharmD, MD, MSc) with extensive experience in regulatory leadership, including leadership of global teams.
- Proven track record of success in supporting successful Phase I-III clinical trials, including leading successful submission of investigational new drug (IND) applications and marketing approval-directed filings.
- Ability to coordinate the preparation of a variety of CMC regulatory documents in collaboration with other business functions.
- Ability to leverage deep oncology regulatory experience to provide teams with guidance on innovative approaches informed by regulatory precedent and emergent opportunities for the global registration of therapeutics.
- Ability to dissect complex issues to quickly distill key issues for discussion with regulatory authorities and guide teams in the preparation of response to regulatory questions.
- Ability to partner closely with senior leaders, cross functional teams within Development and eventually Commercial, to develop regulatory strategies in close alignment with business objectives across therapeutic areas.
- Strong interpersonal skills that facilitate collaboration across functions to identify business solutions on regulatory issues. Cultural awareness and sensitivity to achieve results across both regional country and international borders.
- Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements and understand current global and regional trends in regulatory affairs with ability to assess the impact of these requirements to the business.
- Must be capable of playing the lead role in updating and preparing the company for major changes in legislation which impact across departments.
- Must be capable of critically reviewing complex technical documents and influencing colleagues across functions.
- Ability to work independently in a dynamic, fast-moving environment, but also as part of a collaborative and innovative team.
- Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
- 401k plan with company matching
- Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
- Mental health and wellness benefits
- Weeklong summer and winter holiday shutdowns
- Generous paid time off and holiday policies
- Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
The expected salary range for this role is $257,000 to $295,000 depending on skills, competency and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to have received both an FDA-approved primary vaccine series and at least one booster vaccine against COVID-19 as of their start date. If you are unable to meet this requirement due to a disability or serious medical condition, or due to a sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.
Job posted: 2022-11-15