Another Regulatory Affairs Specialist......this time US based.

[kmall]

Tarin Araujo - Senior Manager, Regulatory Affairs, Geron Corporation

Hired - May 2022

4/21/2022 - FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 505,800 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. Tarin Araujo is one of these newly hired employees.

Tarin's former employers include: JNJ, Elevar Therapeutics, Esperion Therapeutics, Medtronic, John Hopkins Hospital, US Army

"Diverse Healthcare Professional and Military Veteran offering 20+ years of proven experience in clinical research, regulatory affairs, healthcare program management and sales with nine years of experience in domestic and international drug and medical device regulations for multiple therapeutic areas."

Geron has been looking to fill this position for quite some time.........

Tarin's expertise includes:

"Regulatory lead for global development programs from Pre-Phase I to III.
• Lead and prepare applications for ODD, BTD, and Fast Track applications.
• Author content, and provide strategic guidance to regulatory submissions (IND, NDA, and CTAs, both original applications and amendments). Support clinical and medical writing colleagues to develop IBs, DSURs, CSRs, CDPs, and clinical protocols."

"Provide guidance on clinical and regulatory strategy for Food and Drug Administration (FDA) and global regulatory submissions.
• Responsible for Quality Control checks of all Regulatory submissions.
• Collect, review, and approve clinical site essential documents for the electronic Trial Master File.
• Responsible for clinical supply site activation forms for investigational product shipments and
global site activation forms.
• Regulatory liaison for Contract Research Organizations (CRO) contracted to author documents for Ethics Committee and Competent Authority (MOH) global submissions, such as, Clinical Trial Applications, amendments to submissions, and responses to agency questions.
• Author submission content for reportable Safety Event submissions, Investigator listings, Annual
Report updates for Investigator Brochure (IB), Development Safety Update Report (DSUR) and Clinical Study Report (CSR) for Investigational New Drug (IND) applications and New Drug Applications (NDA) content.
• Manage the United States (US) and Outside United States (OUS) regulatory submission project trackers and lead cross-functional project team meetings for annual project updates and clinical regulatory status meetings.
• Responsible for document-level publishing of all Food and Drug Administration submissions in eCTD format."

It looks like Tarin was well worth the wait.

Speaking of waiting........it should be an interesting week with the Q1 financial forecast and follow up Conference Call on Tuesday. As well as EHA abstracts being released May 12th....thanks bp!! If someone doesn't mind posting highlights from any of the above, it would be greatly appreciated, as I'm still out of the country with my snorkel mask and fins on.......I'll be coming up for air periodically to post new hires when I'm in range of internet service. -Kmall

[kmall]

Known current Geron Employees as of 5/09/2022 and their initial hiring dates –
* Former Janssen employee
+ Part-time or Consultant

Management:
1 - CEO – Dr. John A. Scarlett, MD - 2011
2 - CFO – Olivia K. Bloom - 1994
3 - CAO – Melissa A. Kelly Behrs – 1998
4. – CBO – Edward Koval - 2021
5 - COO – Andrew J. Grethlein - 2012
6 - CCO* – Anil Kapur - 2019
7 - CMO* – Aleksandra Rizo, MD - 2019
8 - CLO – Stephen N. Rosenfield - 2011

Clinical – Operations, Science, Development:
Aleksandra Rizo*(6), MD – CMO – 2019
9 - Laurie Sherman* – VP Clinical Operations – 2019
10 - Faye Feller* - VP Clinical Development – 2019
11 - Souria Dougherty* - Ex Director Clinical Science - 2019
12 - Tymara Berry – Ex Director Clinical Development - 2020
13 - Sheetal Shah – Sr Director – 2020
14 - Denise Redding – Director - 2021
15 - Jeff Ryel – Director Clinical Operations - 2020
16 - Karie Arnold – Director Clinical Operations – 2021
17 - Brandie Jonas – Director Program Management – 2019
18 - F Matthew Bakthasekaran - Sr Manger, Clinical Program Management - 2022
19 – Carolina Jacobs – Sr Project Manager - 2012
20 - Daria Zielinska – Sr Scientist – 2001
21 - Ron Pruzan – Principal Scientist – 2010
22 – Yelena Polonskaya – Sr Research Associate - 2001
23 - Barbara Mandelkow (Germany) Lab Assistant - 2017
24 - Mebratu Gebreyesus(+) - Sr Development Associate - 2010
(currently employed at Bayer, Celtheon and Geron)
25 - Kerry Mundt(+) – CT Assistant – 2010
(currently employed by Pharmacyclics/Abbvie and Geron)

Pharmacovigilance and Drug Safety/Information:
26 - Patti N. – Ex Director Drug Safety – 2020
27 – Annat Ikin - Director Medical Writing, Geron Corporation – Nov 2021

Business Development:
Melissa A. Kelly Behrs (3) – Chief Alliance Officer – 2014
Edward Koval (4) – CBO - 2021
Anil Kaur* (6) - COO - 2019
28 - Lynn Bodarky – VP Business Development – 2019
29 - Denise Meyer – VP Medical Affairs – 2021
30 - Helen Lee – Sr. Reporting Analyst - 2012
31 - Anthony Kuczynski – Analyst - 2019
32 - Aron Feingold - VP Investor Relations & Corporate Communication - 2022

Finance:
Olivia K. Bloom (2) – CFO – 1994
33 - Karen Boyce – VP -2008
34 - Andrew Good – Ex Director – 2006
35 - Lilly Huang – Ex Director, CPA - 2019
36 - Gilian Fong – Director – 2021
37 - Vivian Pham – Sr. Accountant – 2006
38 – Iasko Cable – Sr. Clinical Trial Accountant – 2019
39 – Dave Clark – CPA, Corporate Controller - 2022

Data Management:
40 - Dan Miller – Sr. Director – 2019
41 - Rana F.* – Director, Statistical Programming - 2020
42 - Sridevi Sridhar, CCDM – Associate Director – 2021

Manufacturing:
43 - Patrick Murphy – VP Manufacturing – 2019
44 - Eric Mueller – Director – 2019
45 - Leslie C. – CMC Director - 2021
46 - Bharat Baral* – CMC Manager – 2021 & 2011
47 - William Garzon-Rodriguez* - Associate Director Drug Product Manufacturing, Geron Corporation – April 2021
48 - Tim Tickner – Director, Supply Chain Management, Geron Corporation – Jan 2022

Regulatory:
49 - Sharon McBain* - VP Global - 2019
50 - Shirin Mirshamsi* – Director EU – 2019
51 - Ilesh Sanathra* - Director Global – 2020
52 - Nick Lyon – Director – 2020
53 – Ronan Balicanta* - 2022
54 - Tarin Araujo - Senior Manager US - 2022

Biostatistics:
55 - Ying Wan* – VP - 2019
56 - Libo Sun* – Director - 2019

Quality Assurance and Quality Control:
57 - Denise Grippo – VP Quality and Compliance – 2019
58 - Samantha Taylor – QA Manager, Document Control – 2007
59 - Joe Denton – Director – 2019
60 - John Brenner – Director – 2020
61 - Damanjit Singh – Sr Manager – 2018
62 - Willie Mobley – Materials/Document Specialist - 2007
63 - Leah Wood – Manager – 2021
64 - Murugappa Vedachalam (+) – QA/QC/CMC Consultant - 2019

Legal and Intellectual Property:
Stephen L. Rosenfield (8) – CLO – 2011
65 - Pamela Smith – Associate General Counsel - 1999
66 - Christopher Johnson – Director - 2019
67 - Laura Reederson – Director - 2020
68 - Leslie Mooi – VP IP – 2007
69 - Abby B. – Sr Patent Paralegal - 2014
70 - Cheryl Northern – Sr. Contracts Manager – 2007
71 – Brittney Hernandez – Contracts Manager – 2021

Facilities Operations and Information Technology:
72 - Michael Yamada – VP -2007
73 - Jyoti Shetty – Sr Director IT – 2021
74 - Miguel Hundelt – Systems Administrator – 2018
75 – Julian Cornejo - Systems Administrator - 2021
76 - Briana Martinez – Ex Assistant - 2006
77 - Julia Mensing – Ex Assistant – 2011
78 - Stacie W. – Ex Assistant - 2020
79 - Mia Pham – Office Manager - 2020

Human Resources:
80 - Shannon Odam – HR Executive -2019
81 - Stephanie Dellari – Director - 2004
82 - Susan Finan – Employee Benefits – 2021
83 - Marisa Cerniglia - Manager, People Operations at Geron Corporation – Oct 2021
84 – Jennifer Allen - Associate Director, Talent Acquisition, Geron Corporation – Jan 2022
85 – Fiona McAuliffe – Talent Acquisition Associate – March 2022

*With approximately 85 "known" employees at this point, it's fairly safe to assume there are about a half dozen or so "unannounced" employees, pushing the total employee count into the 90-100 range. -Kmall

[kmall]

For those of you keeping track......

Geron Employee #60 from the list above:
John Brenner - Director, Clinical Quality Assurance at Geron since 2020 has moved on as of this month - May 2022

John Brenner is now Senior Director GCP QA at Syndax Pharmaceuticals in NYC.

We wish Mr. Brenner best of luck in his future endeavors. -Kmall

[Bridge to Sell]

Good luck everyone. I'm not going to stick around and get harassed by guys like Kmall.

[kmall]

@Bridge To Sell.......

I think you may be painting your statement with a very broad brush. John Brenner was hired in November 2020. That month 80,000 shares were granted to Mr Brenner as non-statutory stock options at an exercise price of $1.90.

I for one have no first hand knowledge of why Mr Brenner has decided to part ways with Geron at this time. It could be a multitude of reasons. What I do know is that out of the last 13 positions Mr Brenner has had with various companies, one of those being his own - The GXP Group LLC - 9 of those positions he stayed with for less than 2.5 years......most of those 9 were less than 2 years. He was with Geron for 1 year and 7 months. There seems to be a pattern of not letting the grass grow under his feet for very long......another assumption of course.

You are correct that in his position with Geron as Director GCP QA, Mr Brenner was privy to current P3 data. Perhaps he was simply offered a bigger paycheck with the more prestigious title of Senior in front of the Director GCP QA part, and with even more options? That would be another assumption, which I wouldn't think serves any purpose on this board. I would recommend saving assumptions for the YMB. Imetelchat tends to be a more factual oriented resource of information. -Kmall

[biopearl123]

Well, here is one view of what a Clinical Quality Specialist does:

What does a clinical quality officer do?
What Does a Professional in this Career Do? Ensures that the quality of the work in a clinical environment is consistent and meets government and industry standards as well as customer expectations. Verifies compliance with health and safety regulations.

I am not sure this necessarily means direct contact with raw patient data but rather ensuring systems for collection and cataloging of such. There are many regulations that must be met. It is possible he was brought in for a specific task which was met. Clearly his short employment times in other positions would be a negative unless the intention was a short employment time to begin with. It seems unlikely he would have left because he saw actual data and could interpret them in the presence of a blinded study. I suppose its possible but I would think the raw data is pretty protected and tightly held. He is position would seem to be more about how the data is collected and in what environment. He would only get to see one part of the elephant. Doubt the reason he left was because he saw something he didn’t like. Regards, bp

[Bridge to Sell]

Good luck everyone. I'm not going to stick around and get harassed by guys like Kmall.

[Zhears]

1 person leaving before the there shares vest doesn't make much of a data set. Now, if 5 people jump ship in the next month or 2, then we will no doubt speculate wildly.

[kmall]

@Bridge To Sell........

If I was "sweeping" anything "under the rug" then I probably wouldn't have posted about John Brenner parting ways in the first place. You do realize that the fact that he left was first mentioned in this thread due to research on the employee base of Geron and not merely a "new job announcement" as you've suggested?

I do appreciate your contributions and insight, but as far as Mr Brenner is concerned, I believe
Andrew-bp is most likely on target here. All the best. -Kmall

[kmall]

For those of you keeping track Pt II........

From the most current "known" employee list above......

Employee #35 - Lilly Huang, Executive Director, CPA at Geron Corporation has parted ways with Geron as of January 2022.

Ms. Huang is currently employed with A Semiconductor in San Jose, CA.

We would like to wish Ms Huang the best of luck with her new endeavors.

A revised list of "known" employees regarding recent changes will be made in the very near future. -Kmall