Description

Position Summary 
The Senior Medical Director, Clinical Development for the Epilepsy Program will formulate clinical development plans and the planning, execution, analysis and interpretation of all clinical studies to support those plans. The candidate will both lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting the overall development strategy for one program and will work with senior leaders to support clinical trials in other programs. The focus will be on orphan adult and pediatric neurologic indications currently in the Praxis pipeline, with an emphasis in epilepsy.
Responsibilities 

• Provide strategic 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 including biomarker and translational studies, natural history studies, and clinical trials 
• Participate in interpretation of data analyses of clinical trial results and authoring clinical trial reports 
• Provide clinical input into regulatory document preparation 
• Direct publication planning, advisory board meetings and training programs
• Lead clinical study teams
• Provide support for medical monitoring, safety assessment and overall oversight for all clinical studies supporting the CDP 
• 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 clinical leadership and guidance to business development efforts 

Qualifications 

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), non-US equivalent of M.D, or appropriately qualified PhD. Specialty training in neurology or pediatric neurology with expertise in epilepsy, neurophysiology or pain, is highly desirable. 
• At least 5 years of clinical trial experience and at least 2 years of pharmaceutical/biotechnology clinical development experience in neuroscience.
• 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. 
• 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 create 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. 
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.
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