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Medical Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: HCPro, Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Stoke Therapeutics is a biotech company using RNA science todeliver a new generation of genetic medicines. By using aproprietary platform that restores protein levels, we take aim atsevere genetic diseases that have inadequate or no treatmentoptions. Our first area of focus is Dravet syndrome, a severe andprogressive form of epilepsy that strikes children within the firstyear or two of life. For more information, visitwww.stoketherapeutics.com and follow Stoke on Twitter(@StokeTx).

Position Purpose:

This is an opportunity for a clinician at a fast-growing companyfocused on precision medicines for genetic diseases. JoinStoke’s experienced and dedicated team to lead the development oftransformative therapies for life threatening diseases. The SeniorMedical Director will lead and drive strategy for the company’sglobal genetic epilepsy clinical development portfolio, includingDravet syndrome, taking into consideration medical, scientific,regulatory and commercial aspects. This position will also lead amulti-disciplinary, matrix team through highly complex decisions.This individual has the ultimate responsibility for developmentdecisions assessing and integrating the input from variousdisciplines to create, maintain, and execute a global clinicaldevelopment plan for each clinical program that will result in theregulatory approval of the compounds in multiple regions. Thisindividual interacts with and influences senior leadership indecision-making for the projects by setting strategic direction.This individual will have demonstrated a track record of success inhis/her field, the capacity to lead with minimal supervision, planstrategically, achieve goals on time, and communicate effectively.This position also offers the opportunity to apply Stoke’s platformto other serious diseases (including other neurologic diseases andophthalmic diseases) and will take on a major leadership role in arapidly growing organization. This position reports to theChief Medical Officer of the company.

Key Responsibilities Include:

Synopsis / Protocol Development, Study Execution, & StudyInterpretation

Lead and supervise a clinical team of at least one medicaldirector, collaborating closely with the Clinical Operations team,and be accountable for all deliverables of clinical trials underhis/her direct responsibility.

Responsible for the clinical content of all clinical andregulatory documents, including protocols, INDs, CTAs, investigatorbrochures, CRF's, CSRs and IND reports.

Responsible for analysis of clinical data, including safetymonitoring in collaboration with Safety team.

Help ensure Clinical Study Team compliance with FDA, EMA, PMDA,ICH and GCP guidelines and internal SOPs.

Hires, manages, mentors, motivates, empowers, develops, andretains staff to support assigned activities. Conducts performancereviews and drives goal setting and development planning.

Clinical Development team leadership

Lead Global Development Team for Dravet Program.

Establish and drive Development Team strategy and deliverablesproducing the Development Strategy and Clinical Development Plan.Provide continual critical evaluation of the development strategyto maintain a state-of-the-art development plan.

Responsible for high impact global decisions: monitoring andinterpreting data from ongoing internal and external studies,assessing the medical and scientific implications, and makingrecommendations that impact regional and global development such asgo/no go decisions or modification of development plans or studydesigns that may have a significant impact on timelines or productlabeling.

Communicate program developments and clinical trial results tosenior management and collaborate with senior management on keystrategy and decision-making.

Contribute in an active and ongoing manner to the scientific,clinical, and commercial development of current and future productcandidates.

Aid in developing the clinical strategy for our portfolioprograms and work cross-functionally to evaluate, select, plan andexecute R&D projects.

External Interactions

Represent clinical development at FDA, CHMP, PMDA and otherregulatory agencies.

Develop and maintain relationships with key opinion leaders andPrincipal Investigators.

Organize and present at relevant clinical advisory boards andmedical meetings.

Write manuscripts, publications, or other documents intended forexternal audiences.

Due Diligence, Business Development and Alliance Projects

Participate in evaluation of potential business developmentopportunities, conduct due diligence evaluations, and developmentand negotiation of clinical development plans for potentialalliances and or in-licensing opportunities.

Requirements

Required Experience:

MD or MD/PhD.

Board certified or eligible in a medical or pediatricsubspecialty preferred.

Expertise in Neurology or Orphan diseases preferred.

8+ years of overall relevant experience withinpharmaceutical/biotech industry or academic medicine.

At least I2 years of early clinical development experience in anindustry setting.

Experience with oligonucleotide therapeutics is anadvantage.

Experience with design, execution, and analysis of Phase 1-2aclinical studies

Thorough understanding of Phase I-III drug development withproven ability to plan and conduct clinical trials, deliver highquality results within established timelines, interpret, analyze,and communicate clinical/scientific data.

Excellent written and verbal communication skills to meet theneeds of varied audiences.

Strong interpersonal skills commensurate with the need to workclosely with partners, investigators, contractors, consultants, andteam members across functions.

Knowledge of FDA/EMA requirements, good clinical practices, andpharmaceutical clinical development.

Excellent analytical, problem-solving, and strategic planningskills

Well organized with strong management, leadership, mentoring andmotivational skills.

Ability to work independently and thrive in a fast-pacedenvironment.

Attention to detail, demand for high-quality work, and sense ofpassion and urgency to achieve goals and improve the lives ofpatients.

Travel:

Approximately 30% of this position will require travel (domesticand international).

Location(s):

This position will primarily be located in Cambridge, MA, andmay also work occasionally from Bedford, MA.

Benefits & Compensation:

Stoke Therapeutics offers comprehensive and competitive employeebenefits, including: medical, dental and vision insurance; life,long and short-term disability insurance; Paid Primary CaregiverLeave; a 401K program with company match, and an Employee StockPurchase Program (ESPP). Compensation will be highly competitivefor the industry and directly commensurate with experience.

Interested candidates should apply directly to the positionlisted on Stoke’s website:

Location:

Cambridge, Massachusetts, United States

Position Title: Senior Medical Director

Company Name: Stoke Therapeutics

Job Function: Medical

Job Type: Full-Time

Job Duration: Indefinite

Min Education: Ph.D.

Min Experience: 7-10 Years

Required Travel: 25-50%

Cambridge, MA, United States

Technical Specialist

Cambridge, MA, United States

100 Winners Circle, Suite 300 Brentwood, Tennessee 37027 (978)624-4594

Keywords: HCPro, Inc., Cambridge , Senior Medical Director, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Medical Director, Other , Cambridge, Massachusetts

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