Description

Position Summary

As the Senior Director of Clinical Development Movement Disorders you will formulate clinical development plans and the execution, analysis and interpretation of all clinical studies to support those plans within the Praxis movement disorder franchise. You will help oversee cross-functional teams to plan, generate, deliver, and disseminate high-quality clinical data supporting the overall development strategy for the Movement Disorders program. Working with leadership, you’ll also support clinical trials in other programs.

Primary Responsibilities

• Provide strategic medical leadership that integrates knowledge of disease pathophysiology and clinical course with the hypothesized mechanism of action of the drug
• Formulate clinical development plans (CDP) that integrate scientific rationale, clinical need, clinical measurement approaches, statistical rigor, regulatory and payor requirements, and company strategy
• Develop and implement high quality clinical studies to support the CDP
• Participate in interpretation of data analyses of clinical trial results and authoring clinical trial reports
• Provide medical monitoring, safety assessment and overall oversight for all clinical studies supporting the CDP
• Support clinical study teams
• Provide medical input into regulatory document preparation
• Direct publication planning, movement disorders clinical advisory board meetings and training programs
• Establish and operate within appropriate timelines and budgets for clinical studies
• Develop and maintain strong relationships with program counterparts in internal functions as well as external collaborative relationships
• Present at investigator meetings, advisory meetings, regulatory meetings, and represent Praxis at professional meetings
• Contribute medical leadership and guidance to business development efforts

Qualifications and Key Success Factors

• The ideal candidate will have a mix of the following professional and personal characteristics
• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), non-US equivalent of M.D with specialty training in neurology with expertise in movement disorders
• At least 3 years of industry clinical experience
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols. Formal training in clinical research methods is a plus.
• Working knowledge of GCP/ICH guidelines.
• Working knowledge of the IND and NDA processes and experience with regulatory submissions is required.
• Must possess excellent oral and written English communication skills.
• High integrity and ability to bring out the best in others, intellectually and interpersonally, on a cross-functional team.
• Ability to prioritize across complex clinical research studies.
• Demonstrated strategic and critical thinking skills.
• Ability to interact externally and internally to support the scientific and business strategy.
• Ability to exercise judgment and address complex problems and find solutions across multiple projects.

Additional Information

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes: 

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this world-class total rewards package, we provide base salary compensation in the range of $300k to $335k. Final salary range may be modified commensurate with job level, education, and experience.

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.Additional Requirement
To safeguard the health of our employees, their families, our partners and visitors, and our communities, Praxis requires that all employees be up to date on their COVID-19 vaccinations. Further, we reserve the right to ask for or check the status of CDC recommended booster shots. Employees may be required to provide proof of such vaccinations before beginning employment, except where prohibited by law. Requests for exemption will be considered and Praxis will provide reasonable accommodations unless doing so would pose an undue hardship.Diversity, Equity & Inclusion
Guided by our core values, 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.

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.
Attention: Job Scam Alert
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