AeroLeads people directory · profile
Daniel N. Email & Phone Number
Head of Patient Safety and Risk Management
at
Bicara Therapeutics
LinkedIn matched
✓ Verified July 2026
3 data sources
Profile completeness 86%
Current company
Role
Head of Patient Safety and Risk Management
Location
Walpole, Massachusetts, United States
Company size
Who is Daniel N.? Overview
A concise factual answer block for searchers comparing this professional profile.
Quick answer
Daniel N. is listed as Head of Patient Safety and Risk Management at Bicara Therapeutics, a with 73 employees, based in Walpole, Massachusetts, United States. AeroLeads shows a matched LinkedIn profile for Daniel N..
Daniel N. previously worked as Safety Evaluation and Risk Management Group Lead at Gsk and Head of Patient Safety and Risk Management at Scholar Rock. Daniel N. holds Doctor Of Medicine - Md from Aureus University School Of Medicine.
Company email context
Email format at Bicara Therapeutics
This section adds company-level context without repeating Daniel N.'s masked contact details.
Bicara Therapeutics
Review company-level records connected to Daniel N. before choosing the right outreach path.
Profile bio
About Daniel N.
Physician, Researcher, Former Combat Veteran, Avid fitness lover, outdoorsman, leader, mentor and friend. · Recipient of the Leader/Mentor of the Year Award 2019 from Takeda Pharmaceuticals for extraordinaire leadership and mentoring of colleagues across the organization· Led the implementation of benefit risk, and risk management, risk minimization programs across two biopharma organizations Fresenius Medical Care North America and Scholar Rock· Extensive submission expertise across multiple oncology/hematology products- ALL, and CML· Led multiple initiatives and studies for cardiovascular safety within oncology drug development that resulted safety related labeling changes· Recipient of two R & D awards for co-development of a predictive risk analysis to mitigate toxicities associated with an oncology product and for initiatives involving Cardiovascular risks for an oncology product· Successfully led multiple post-launch medical safety work streams concerning the removal of risk minimization pro-grams across multiple major markets (US-ETASU REMS, EMA- Restricted Distribution, and Canadian and Australian Controlled Distribution programs)
Current workplace
Daniel N.'s current company
Company context helps verify the profile and gives searchers a useful next step.
Bicara Therapeutics
11 roles · 27 years
Daniel N. work experience
A career timeline built from the work history available for this profile.
Safety Evaluation And Risk Management Group Lead
• Provided leadership and oversight for safety and risk management activities for clinical development and marketed products within for hematology and immunology• Managed and developed a team of direct (8 reports) and indirect reports of safety physicians and scientists • Ensured key safety documents and deliverables (e.g., safety-related sections of clinical protocols, ICFs and CSRs, signal assessment reports, reference safety information, aggregate reports, regulatory submissions and responses, safety content for internal and external communications) meet standards of quality and timeliness across two major product families• Served as primary point of contact for all patient safety-related activities, or supporting the Safety Leads• Provided direction and strategy on process improvements, individual and team interactions and overall SERM efficiency • Provided leadership support for a hematology submission- medical safety strategy for submission dossier development, in-tegrated safety strategy authoring and development• Provided Sr. Safety Physician medical guidance across assets for Pulmonary, Gastrointestinal, Neurological and Oncology indications
Head Of Patient Safety And Risk Management
• Led the implementation of the patient safety and risk management organization• Created a medical safety and safety operations organization to support late phase development of multiple company assets• Successfully implemented a development signal detection and risk management program• Created a benefit risk program utilizing the FDA’s and EMA framework• Global Safety Lead for TGF-B immuno-oncology and rare neuromuscular disease programs• 6 direct reports
Jan 2020 - Dec 2021
Global Senior Medical Director, Oncology & Cell Therapies
· Led 16 health authority negotiations regarding medical safety matters, endpoint adjudication, and integrated safety analysis, to support regulatory submissions and labeling negotiations· Led the initiation of a cell therapy program for hepatocellular carcinoma· Provided oversight and successful collaboration with 4 distribution and 2 licensing partners· Successfully led the harmonization, implementation, and removal of multiple risk minimization programs in major markets (US-REMS, Canadian CDP, and Australian Risk Mitigation Programs)· Provided leadership in the evaluation of complex safety signals to include the establishing a cardiovascular endpoint adjudication committee· Launched an early phase pediatric study program while pioneering the use of predictive safety biomarkers to predict and mitigate cardiovascular toxicities across pediatric oncology studies for CML and Philadelphia positive ALL· Successfully pioneered the utilization of qualitative (FDAs Structured Benefit Risk AssessmentTool) and quantitative (Quality of Life without Symptoms of Toxicity) benefit risk assessment· Provided medical safety content in support of four protocols, IBs, PBRERs, and DSURs· Successfully promoted from Associate Medical Director to Medical Director, to Senior Medical Director
Mar 2017 - Jan 2020
Associate Director, Drug Safety Physician/Reviewer
· Provided medical review of CIOMS and Safety narratives along with risk management of assigned for psychiatric (Aristada), addiction (Vivitrol), and neuroscience products· Provided medical safety content in support of two protocols, IBs, PBRERs, and DSURs
Oct 2016 - Mar 2017
Director, Drug And Device Safety
· Directed an initiative to globally harmonize medical safety governance for the organization· Guided the creation of a medical safety program for the Fresenius’ pharmaceutical products· Led multiple medical safety initiatives to evaluate cardiovascular toxicity associated with patientssuffering from chronic kidney disease resulting in improvements to dialysate product development· Successfully created and spearheaded safety governance and a field alert program to address two FDA warning letters ultimately resulting in their removal· Provided medical safety leadership to support of nephrology products to include combination product (peritoneal dialysis, hemodialysis and dialysates) protocols, IBs, PBRERs, DSURs, health hazard assessments, and field alert re-porting
Apr 2015 - Oct 2016
Pharmacovigilance Contactor
· Successfully provided medical safety support for the Medi4736- Durvalumab submission· Performed signal evaluations for pulmonary toxicities and provided support for DSURs
Oct 2014 - Apr 2015
Drug Safety Physician
· Supported medical monitoring activities across oncology, and psychiatric products· Provided medical safety content in support of protocols, IBs, PBRERs, and DSURs· Authored PBRERs, DSURs, and signal detection
Oct 2014 - Jan 2015
Financial Advisor
2007 - 2009
~2 yrs
Associate Manager
2005 - 2007
~2 yrs
Staff Sergeant, Aviation Production Control/Flight Engineer
2000 - 2005
~5 yrs
4 education records
Daniel N. education
Doctor Of Medicine - Md
Aureus University School Of Medicine
Post-Doctoral Fellowship, Clinical Research
Larkin Community Hospital
Clinical Research Scholar, Department Of Radiology
Clinical Research Scholar, Department Of Radiology
FAQ
Frequently asked questions about Daniel N.
Quick answers generated from the profile data available on this page.
What company does Daniel N. work for?
Daniel N. works for Bicara Therapeutics.
What is Daniel N.'s role at Bicara Therapeutics?
Daniel N. is listed as Head of Patient Safety and Risk Management at Bicara Therapeutics.
Where is Daniel N. based?
Daniel N. is based in Walpole, Massachusetts, United States while working with Bicara Therapeutics.
What companies has Daniel N. worked for?
Daniel N. has worked for Bicara Therapeutics, Gsk, Scholar Rock, Takeda Oncology, and Alkermes.
How can I contact Daniel N.?
You can use AeroLeads to view verified contact signals for Daniel N. at Bicara Therapeutics, including work email, phone, and LinkedIn data when available.
What schools did Daniel N. attend?
Daniel N. holds Doctor Of Medicine - Md from Aureus University School Of Medicine.
Find 750M verified contacts
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trialPeople with similar names
Check these profiles if this is not the Daniel N. you were looking for.
View similar profiles
