Almas Siddiqui

MS, PhD

*

LMAS SIDDIQUI ** Birchwood Dr,Novato, CA

Cell phone: 415-***-****

Office:415-***-****

Email: adm8ks@r.postjobfree.com

Summary

A Manager with +10 years of experience in regulatory, pharmacovigilance, and clinical studies proven by working on IND and managing +5 research studies including but not limited to Down syndrome, Parkinson’s, Huntington’s, Lupus, and Alzheimer’s disease resulted in +10 publications. Strong communication skills with the ability to build strategic relationships with internal/external stakeholders including but not limited to PIs, CRAs, CRCs, and MSL’s demonstrated by managing +20 stakeholder’s meeting during the integration of polyglot system to SFDPH (San Francisco department of public health) Excellent project manager with planning and organizational skills capable of managing multi-functional projects in alignment with regulations such as GCP, EUMDR, and EUMSR demonstrated by successfully streamlining SaMD for Alzheimer’s disease patient recruitment.

Work Experience

Regulatory affairs consultant

HEKMA Inc • San Rafael, CA. Nov 2017-present

• Manage regulatory operations for SaMD for vendors and FDA and validate the scope for deliverables acceptance, by working continuously with quality and regulatory team in order to utilize EHR from hospitals or organizations such as ALZ.org

• Collaborate with clinical research cites and San Francisco department of public health to engage clinicians and safety net patients with clinical trials and patient recruitments.

• Communicate with cross functional teams to expedite the flow of submission documents through the eDMS and manage timelines and status reports for 510K filing.

• Manage a team to set up eDMS (electronic document management system) and CTMS (clinical trial management system) and provide training to create product/country specific submission checklists

• Monitor the progress of the project to ensure de-novo filing and correspondence are submission ready. Regulatory operation Consultant

Delos Pharmaceuticals • Novato, CA. May2015- May2016

• Managed IND applications and prepare PK/PD reports for mTOR2 inhibitor compound for Lupus disease.

• Maintain proficiency and high quality with electronic Common Technical Document (eCTD) publishing requirements and regulations associated with global regulatory submissions with mTOR2 inhibitor compound.

• Implemented risk management and mitigation strategy to prepare for questions from authorities by preparing data safety update reports and periodic benefit risk evaluation reports.

• Collaborated with CRO’s and work cross functionally with research and business team for IRB approvals and SOPs. Regulatory documentation Consultant

Center for Care and Innovations SFDPH • San Francisco, CA. May 2014- May2015

• Managed regulatory projects to develop a SaMD product (polyglot system) and communicated effectively with key opinion leaders and vendors to mitigate risk and resolving issues associated with the development phase. A

Almas Siddiqui

MS, PhD

2

• Delivered high-quality and high-value products by reviewing contracts, project scope, budgets, and resources by in order to meet project timelines using CTMS

• Worked on delivering technology that can and decrease costs, increase quality, and improve patient and staff satisfaction.

Team Lead- Scientist

The Buck Institute for Research on Aging • Novato, CA. March2008- Dec2015

• Lead the team for drug studies and make successful collaboration with sponsors to use the MAOB genetic mouse model.

• Ccollaborated internally and externally for research funding, manage meetings and timelines for various projects, and represent the institute for outreach through stake engagement at CRO’s.

• Develop several douches including SOPs, grants for NIH/NIA & Michael J Fox foundation resulted in +4 published articles in peer reviewed journals.

• Coordinate shipping and transferring samples and maintaining laboratory information in order to be in compliance to Good Laboratory Practices and Quality Standards.

• Member of IRB committee and collaborated with other team members to approve and review clinical research along with maintaining all legal regulatory and ethics documentations.

• Organize and chair Gordon Research Seminar to facilitate the scientific ideas and cross functional talks between academia and industry.

Research Scientist

UNIVERSITY OF DENVER ELEANOR ROOSEVELT INSTITUTE • Denver, CO. Aug2005-May2007

• Mentored +10 students through their research projects and collaborated with different departments to solve research problems by reviewing literature and clinical studies

• Conducted research studies on Down syndrome prevention and presented the results of the studies in peer reviewed journal.

• Performed PK/PD studies on Mk801 inhibitors using down syndrome mouse models. Education

Ph.D. Toxicology, Hamdard University, New Delhi, India Master’s in science, Toxicology, Hamdard University, New Delhi, India Professional Training and Certificates

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)

• Scientific Leadership and Management Course, Gladstone Institute, San Francisco, CA

• Healthcare Innovation and Entrepreneurship, Duke University

• Regulatory Affairs Certificate Course on Pharmaceutical and Devices, Regulatory affairs professional society

• Understanding and Managing the US Clinical Trial Process, Regulatory affairs professional society o Write reports, manage sites and collaborate with principal investigators. o Effectively learned how to review Informed Consent Forms (ICF), Case Report Forms (CRFs) and conduct Source Data Review (SDR) and Source Data Verification (SDV) o Contributed in discussions relevant to sponsors, CROs, IRBs, and clinical study protocols and with great understanding of adverse drug events (ADEs); Serious Adverse Event (SAE); eCRF and EDC successfully completed all exercises required by the course

Almas Siddiqui

MS, PhD

3

Component Skills

UAT, CTM

De-novo filing

GDP

MedDRA/eCTD/IP

Quality Assurance

Project Management

Clinical Trials ICH-GCP Stakeholder engagement

IND and NDA filing

CFR21 and cGMP

Pre-market approvals

Selected Awards, Honors and Hobbies

• Buck Institute Research Fellowship Award, 2013

• Gordon Research Seminar in Oxidative Stress and Diseases, Ventura CA, Chair, 2011

(https://www.grc.org/oxidative-stress-and-disease-grs-conference/2011/)

• Senior Research Fellow Award, Central Council Research in Unani Medicine, New Delhi, India, 2000

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