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Praxis Precision Medicines, Inc.
United States - Remote
Source: Praxis Precision Medicines, Inc. careers · View original posting
From Praxis Precision Medicines, Inc.'s posting. “We” and “our” refer to the employer.
This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The Opportunity
We are looking for a Senior Director to lead Analytical Development across our small molecule and oligonucleotide portfolios. You will set the scientific direction, build the team, and ensure our methods, specifications, stability programs, and control strategies are ready for each stage of development, from pre-IND work through potential NDA/MAA approval.
This is a hands-on leadership role in a growing, agile organization. You will make consequential technical decisions, work closely with colleagues across Development CMC, Quality, Regulatory Affairs, and Clinical Supply, and hold external partners to a high standard. Your work will help move promising molecules toward medicines for patients.
Primary Responsibilities
Set the analytical strategy.
Define and execute an approach for drug substance and drug product across the small molecule and oligonucleotide portfolios. Make clear choices about what each program needs now and what it will need at the next clinical or regulatory milestone.
Build reliable methods and controls.
Lead analytical method development, qualification, validation, transfer, and lifecycle management. Establish specifications, comparability approaches, and control strategies with Process Development, Quality, and Regulatory Affairs.
Deliver regulatory-ready science.
Author and review analytical CMC content for IND, IMPD/CTA, and NDA/MAA submissions. Represent Analytical Development in health authority interactions and explain the science clearly under scrutiny.
Lead external execution.
Oversee CDMOs, CROs, and contract testing laboratories, including method transfers, stability programs, and investigations of out-of-specification or out-of-trend results. Surface risks early and drive them to resolution.
Build the function.
Hire, coach, and develop a strong analytical team. Shape its structure and capabilities as the portfolio grows, while giving people clear ownership and direct, useful feedback.
Connect the work to program decisions.
Partner with Process Development, Formulation Development, Clinical Supply, Quality, Regulatory Affairs, and program teams so analytical deliverables support sound decisions and meet program timelines. Lead CMC teams and represent CMC function on cross functional program teams.
Raise the standard.
Champion data integrity, GMP compliance, and continuous improvement. Stay current with analytical technologies and regulatory expectations, and apply new approaches when they will improve the work.
Compensation
At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.
We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!
To round out our world-class total rewards package, we provide annualized base salary in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job-related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.
Annualized Base Salary
$250,000 — $275,000 USD
At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.
We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!
Company Overview
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and
Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE
® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Attention: Job Scam Alert
Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com.
Praxis does not accept unsolicited submissions from recruitment agencies for open positions.
We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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