Vice President, Clinical Development
4 weeks ago
At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we're committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Position Summary
This critical leadership position reporting to the Chief Medical Officer will lead clinical development for Editas' expanding clinical portfolio supported by our unique gene editing platform. The position represents a key partner in establishing and driving forward tactical plans to enable Editas to deliver on its mission to translate the power and potential of genome editing into a broad class of in-vivo and cellular treatments that transform lives of people living with serious diseases.
The VP, Clinical Development will play a key role in leading the strategy, development, and execution of the clinical pipeline. The incumbent is expected to have a strong clinical, regulatory and scientific foundation, and will work closely with the cross functional drug development teams to define the most effective approach from first-in-human to registrational clinical studies.
As a key strategic functional leader, the incumbent will work across a matrixed organization with Research, Clinical Operations, Regulatory, Biometrics and other functions to ensure integrated development strategies. He/She will be a key Editas spokesperson at external meetings, including regulatory interactions and scientific meetings and partner with Medical Affairs, Commercial and Corporate Communications in setting external messaging and communication strategies.
The incumbent is expected to be a strong people manager and be willing to 'roll up the sleeves' as needed to accomplish company goals. He/She will lead a group of physicians and clinical scientists who have responsibility for conceiving, delivering, and overseeing Phase 1-3 trials progressing from pre-IND activities to BLAs, establishing plans for long-term follow up and pharmacovigilance, and is responsible for protocol development and clinical sections of regulatory documents (e,g. IND submission, briefing documents, study protocols, investigator brochures and other study-relevant documents like patient informed consent documents).
Key Responsibilities:
* Be a strong, clear voice and leadership for Editas' clinical programs in partnership with other Functions.
* Apply clinical development area expertise to promote innovation and efficiency in clinical development programs
* Point responsibility for all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.
* Collaborate with Commercial, Legal, and Regulatory for development and review of labelling, advertising and promotional materials
* Be responsible for establishing clinical development plans and accountable to relevant timelines and deliverables associated to Clinical development Plans.
* Provide leadership, coaching, and mentorship to the clinical development team members and ensure their deliverables on key program and study metrics
* Ensure ongoing medical monitoring and oversight of clinical trial data, external clinical data collection
* Provide strategic perspective and guidance to Research on decisions that may have significant clinical components and implications.
* Collaborate closely with Non-clinical, Regulatory, Clinical Operations, CMC and Biometrics to ensure tight strategic integration of product development plans and strategies.
* Maintain the highest quality clinical programs, following GCP and ICH guidelines
* Deep knowledge in clinical development, extensive experience in regulatory engagement
* Proven track record of successfully driving from first in human study to registration. BLA (or NDA) /MAA submission experience expected.
* MD or MD/PhD with therapeutically aligned experience
* 15+ years clinical research experience, with a minimum of ten years in the pharmaceutical/biotechnology industry
* Demonstrated ability as a line function manager
Preferred:
* Experience or high comfort level in supporting clinical programs across multiple therapeutic areas, and bridging late to early development, familiarity with gene and/or cell therapy a plus
* Exposure to and management of significant accelerations and challenges in clinical programs.
* Ability to work with the Senior Executive Team and other external audiences such KOLs, regulatory bodies
Physical & Travel Requirements (if applicable):
* Willingness and ability to travel, as required to support company goals and portfolio (COVID dependent)
If you are a results-focused and collaborative leader with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.
Benefits Summary:
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.
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