Medical Director Job at FCS, Inc Prince (Cleveland)

Senior Medical Director / Medical Director, Pharmacovigilance

The Medical Director of Pharmacovigilance (PV) will provide clinical/scientific/...

Location

United States , Cambridge, MA

Salary:

210000.00 - 375000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

MD required, Board certification preferred with 15+ years of experience
5+ years of pharmacovigilance experience
Experience in cell or gene therapy preferred
Experience as safety lead for asset/approved drug product e.g. Global Safety Lead
Oversight experience of global medical safety activities
Demonstrated knowledge of global PV regulatory environment
Working knowledge of industry standard safety databases (ARGUS and ARISg)
Knowledge of MedDRA dictionary
Excellent knowledge of drug development process
Experience reviewing cumulative safety data

Job Responsibility

Provide dynamic leadership, strategic direction and governance of patient safety and PV risk management activities
Lead signal detection and risk management activities for assigned products
Lead proactive and ongoing analysis and interpretation of non-clinical data, clinical, post-marketing, scientific literature
Lead PV during interactions with Regulatory Authorities (RA)
Perform individual case safety report (ICSR) medical review
Lead multidisciplinary Safety Management Committee (SMC) and Executive Safety Committee (ESC)
Serve as PV SME in support of regulatory filing activities
Collaborate with cross functional team
Address internal/external safety-related requests
Provide guidance regarding Statistical Analysis Plans

Fulltime

Associate Director / Director, Medical Writing

Beam is seeking a highly talented and motivated AD/Director to join our growing ...

Location

United States , Cambridge

Salary:

180000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
MS, PharmD, or PhD preferred in a life science or health discipline
12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents
Excellent communication skills, both oral and written
Ability to build strong relationships and work collaboratively across functions
Effective organizational and meeting skills and attention to detail
Experience with workflow management within standard document management systems
Ability to come onsite when needed such as for important meetings and team/company functions

Job Responsibility

Act as lead writer for clinical regulatory documents for the hematology program
Plan and lead the development of clinical study documents, working with cross-functional colleagues
Work closely with the regulatory team and other writers on regulatory document submissions
Assist with developing and maintaining medical writing process documents
Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor
Contribute to statistical output plans concerning organization and table layout for specific documents
Project management, strategic design, planning, team input, and reviews
Opportunities for management/mentorship of other writers

Fulltime

Medical Director/Senior Medical Director, Clinical Development, Genetic Diseases

The Medical Director in Clinical Development will serve as the Medical Lead for ...

Location

United States , Cambridge

Salary:

210000.00 - 375000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

MD, DO or equivalent ex-US medical degree with 15+ years experience
Minimum of 4 years of Pharmaceutical/Biotech industry experience in clinical development and medical monitoring
Board certification/eligibility in endocrinology or metabolic disorders, or another relevant specialty highly desired
Strong oral and written communication skills to influence others
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
Clinical development and/or clinical experience in rare disease, cell & gene therapy is a plus
Ability to work independently to resolve challenges

Job Responsibility

Serves as the Clinical Development lead on the cross-functional Program Team and co-lead the Clinical Development Sub-team for assigned programs
Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP)
Serves as the medical monitor for assigned studies including design, execution and interpretation study data
Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans
Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP)
Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
Acts as liaison between Clinical Development and other internal groups at BEAM for assigned studies
Establishes strong collaborations with study investigators, outside medical experts and represents BEAM during investigator meetings and advisory boards
Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas

Fulltime

Associate Medical Director, Pediatrics

Provide medical leadership in pediatrics and collaborative clinical support to a...

Location

United States

Salary:

180000.00 - 200000.00 USD / Year

Pomelo Care

Expiration Date

Until further notice

Requirements

Medical degree from an accredited US medical school
Successful completion of an accredited US residency program in a directly related field (Pediatrics or Family Medicine with substantial experience with pediatrics)
A minimum of three years of post-residency experience in pediatric primary care and/or pediatric urgent care
Active, unrestricted license to practice in any US state and willingness to obtain licenses in all US states via the Interstate Medical Licensure Compact
Experience leading successful teams, with track record of outstanding collaboration and teamwork
A sense of urgency to improve clinical outcomes coupled with exceptional organization and attention to detail
A growth mindset with the ability to approach process change and ambiguous situations with enthusiasm, creativity, and accountability
Facility using multiple tech platforms, with an eagerness for advising about platform improvements and adapting to new systems
Eager to thrive in a fast-paced, metric-driven environment
Phenomenal interpersonal and communication skills

Job Responsibility

Provide collaborative physician supervision and consultation for an experienced team of APPs, nursing leadership, and RNs in the field of pediatrics including conducting quality assurance review for Pediatric APPs
Serve as the pediatric medical director in regional cross-disciplinary team-based care coordination meetings and work with in-house clinical specialties to develop holistic individualized care plans
Own clinical content development for our Pediatrics program, serving as the subject matter expert across internal clinician-facing protocols and patient-facing content
Support the recruitment and training of pediatric medical providers
Help drive our population health programs toward healthier outcomes by partnering closely with Market Operations leads and OB Regional Medical Director to identify gaps and improvement opportunities
Identify and implement interventions to address cross-disciplinary or practice performance improvement needs
Facilitate and lead cross-disciplinary review sessions for episodic events and pediatric case reviews
Engage directly in patient care as a Pomelo provider
Actively participate in on-call schedules including overnights, weekends, and holidays

What we offer

Competitive healthcare benefits
Generous equity compensation
Generous PTO policy

Fulltime

Assistant Medical Director - Emergency Medicine

As an Assistant Medical Director of our Palm Beach at Sollis Health you will ove...

Location

United States , Palm Beach

Salary:

Not provided

Sollis Health

Expiration Date

Until further notice

Requirements

Medical Degree from an Accredited University
Physician state license and ability to practice in Florida
ABEM board certified or board eligible required
A minimum of 3 years experience as a physician in the emergency department post residency
Formal previous leadership experience is not required, however traits that show a high potential for being a successful leader are a must
DEA license required
Entrepreneurial nature, excited to build a pioneering healthcare delivery model
Above and beyond customer service ethic
Excellent communication skills and the ability to work cross-functionally among departments and teams
Strong technical and systems skills a plus - ability to manage performance management software, compliance databases, and simple financial models

Job Responsibility

Support the Medical Director as the local medical lead for your assigned clinic working both clinically and administratively
Ensure that the Medical Director’s initiatives and priorities are executed at your assigned location
Manage a team of Providers ensuring they provide the highest standards of care and a high-quality patient experience
Perform medical evaluations and formulate a differential diagnosis and treatment plan for urgent and emergent care within the scope of emergency medicine when working clinical shifts in our centers
Partner with the Medical Operations leadership team to ensure your Center is running efficiently and effectively and that you have a robust staffing model to ensure all shifts are covered and that our patients can access medical services 24/7
Lead by example through continued growth at Sollis, relaying any organizational updates and clinical or non-clinical policy changes to your team that is provided to you by the Medical Director
Ensure patient records are well kept and accurate in our EHR AnthenaHealth, monitoring that team members are adhering to policy
Collaborate with our Medical Partners, Aftercare, Care Navigation and house calls teams to effectuate appropriate referrals and transition of care
Collaborate with the Medical Operations team to ensure that our patients have timely access to imaging modalities as available in your clinic, as well as our full suite of lab tests, with rapid results availability
Collaborate with the People & Culture and Talent Acquisition teams to conduct annual performance reviews, address employee relations concerns, interview and hire quality Providers and championing corporate initiatives

What we offer

Competitive salary aligned with your experience
Excellent benefits, including healthcare, dental, vision
401K with matching 3%
Free Sollis Health membership for you and your family
Employee stock options
Yearly bonus
Annual continuing education allocations
Dedicated, motivated team and chance to be part of a highly ambitious medical startup
Modern, elegant and high-end work environment

Fulltime