Maria Gabriela Becerra

Experienced Site Director with a track record of effective leadership and management. Expertise in overseeing daily operations, executing strategic initiatives, and enhancing safety protocols in construction settings. Demonstrated ability to build strong teams, make informed decisions under pressure, and cultivate relationships with various stakeholders. Recognized for consistently delivering projects on schedule while adhering to industry standards and regulations.

• SARS-CoV-2 Vaccines

∙ A Phase 1,2,3, Placebo-Controlled, Randomized, Observer-Blind, Dose Finding Study To Evaluate The Safety, Tolerability, Immunogenicity, And  Efficacy Of Sars-Cov-2 RNA Vaccine Candidates Against Covid-19 In  Healthy Individuals.

∙ A Randomized, Double-blind, Placebo-controlled Phase 3 Study to  Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of  SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.

∙ A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Study to  Evaluate the Efficacy, Safety, and Immunogenicity of a SARS-CoV-2  Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in Adult Participants ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to < 18 Years).

∙ A Phase 3 Master Protocol To Evaluate Additional Dose(S) Of BNT162B2  In Healthy Individuals Previously Vaccinated With BNT162B2.

∙ A Phase 2,3, Three-Part, Open-Label, Dose-Escalation, Age De escalation and Randomized, Observer-Blind, Placebo-Controlled  Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and  Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6  Months to Less Than 12 Years of Age.

∙ A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled  Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA 1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older.

∙ A Phase 2,3 Study to Evaluate the Immunogenicity and Safety of mRNA  Vaccine Boosters for SARS-CoV-2 Variants.

∙ A Phase 3, Randomized, Observer-Blind Study To Evaluate The Safety,  Tolerability, And Immunogenicity Of Multiple Formulations Of The Vaccine  Candidate Bnt162b2 Against COVID-19 In Healthy Adults 18 Through 55  Years Of Age.

∙ A Phase 2,3, Randomized, Observer-Blind, Placebo-Controlled Study to  Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine  Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age.

∙ Phase 1/2, Randomized, Stratified, Observer-blind Study to Evaluate the  Safety, Reactogenicity, and Immunogenicity of mRNA-1073 (SARS-CoV 2 and Influenza Vaccine) Compared to Co-administered mRNA-1010  (Influenza) and mRNA-1273 (SARS-CoV-2) Vaccines and to mRNA- 1010  Vaccine and mRNA-1273 Vaccine Alone in Healthy Adults 18-75 Years of  Age.

∙ A Phase 3, Randomized, Double-blind, Placebo-controlled Study to  Evaluate the Safety, Tolerability, and Immunogenicity of the Concomitant Administration of Either 23-Valent Pneumococcal Polysaccharide Vaccine  or 15-Valent Pneumococcal Conjugate Vaccine With a Booster Dose of  SARS-CoV-2 mRNA Vaccine in Healthy Adults 50 Years of Age or Older.

∙ A Phase 1,2,3, Placebo-Controlled, Randomized, Observer-Blind, Dose Finding Study To Evaluate The Safety, Tolerability, Immunogenicity, And  Efficacy Of Sars-Cov-2 RNA Vaccine Candidates Against Covid-19 In  Healthy Individuals.

∙ Phase I, Open-Label, Dose-Ranging Study of the Safety and  Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults.

∙ An Interventional, Randomized, Active-Controlled, Phase 2/3 Study To  Investigate The Safety, Tolerability, And Immunogenicity Of Bivalent  Bnt162b RNA-Based Vaccine Candidates As A Booster Dose In Covid-19  Vaccine-Experienced Healthy Individuals.

∙ A Phase 3, Randomized, Observer-Blind Study To Evaluate The Safety,  Tolerability, And Immunogenicity Of Multiple Production Lots And Dose  Levels Of The Vaccine Candidate Bnt162b2 Against Covid-19 In Healthy  Participants 12 Through 50 Years Of Age And The Safety, Tolerability,  And Immunogenicity Of Bnt162b2 RNA-Based Covid-19 Vaccine  Candidates As A Booster Dose In Healthy Participants 18 Through 50  Years Of Age.

∙ A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose Confirmation Study to Evaluate the Safety, Reactogenicity, and  Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18  Years and Older.

∙ Evaluation of the Immunogenicity, Safety, and Tolerability of a Single  Dose of ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for  SARS-CoV-2: a Phase 3 Trial in Two Parts-Randomized, Double-blind,  Active Controlled and Open-label, Single-arm.

∙ Phase 1, Randomized, Observer-blind Study to Evaluate the Safety,  Reactogenicity, and Immunogenicity of Multi-component Vaccines mRNA 1045 (Influenza and RSV) or mRNA-1230 (Influenza, RSV, and SARS CoV-2) Compared With mRNA-1010 (Influenza), mRNA-1345 (RSV), and  mRNA-1273.214 (SARS-CoV-2) Vaccines in Healthy Adults 50-75 Years  of Age.

∙ Study to Evaluate the Safety, Reactogenicity and Immunogenicity of  Modified mRNA Vaccines Using a Systems Biology Approach in Healthy  Adults.

• RSV Vaccines

∙ A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower  Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and  Older.

∙ A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study To  Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Lots Of Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine In Healthy  Adults.

∙ Phase I/II, Observer-blind, Safety, Reactogenicity and Immunogenicity  Study of GSK Biologicals' Respiratory Syncytial Virus (RSV) Vaccine  GSK3844766A in Subjects Aged 18-40 or 60-80 Years.

∙ A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to  Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine  Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age.

∙ A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Trial To  Evaluate The Efficacy And Safety Of A Respiratory Syncytial Virus (RSV)  Prefusion F Subunit Vaccine In Infants Born To Women Vaccinated  During Pregnancy.

∙ A Phase 2b, Randomized, Placebo-Controlled, Observer-Blinded Trial to  Evaluate the Safety, Tolerability, and Immunogenicity of a Respiratory  Syncytial Virus (RSV) Vaccine in Pregnant Women 18 through 49 Years  Of Age And Their Infants.

∙ A Phase 2b, Placebo-Controlled, Randomized, Observer-Blind Study To  Evaluate The Safety, Tolerability, And Immunogenicity Of A Respiratory  Syncytial Virus (RSV) Vaccine When Administered Concomitantly With  Tetanus, Diphtheria, And Acellular Pertussis Vaccine (Tdap) In Healthy  Nonpregnant Women 18 Through 49 Years Of Age.

• Influenza Vaccines

∙ Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine  MRT5407 in Adults Aged 18 Years and Older.

∙ A Phase 1/2, Randomized, Stratified, Observer-Blind, Dose-Ranging  Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of  mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults 18 Years and  Older.

• Pneumonia Vaccines

∙ A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and  Immunogenicity of A 20-Valent Pneumococcal Conjugate Vaccine  (20vpnc) When Coadministered with Seasonal Inactivated Influenza  Vaccine (Siiv) In Adults ≥65 Years of Age.

∙ A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Six Months  Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease.

∙ A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 One Year Later  in Healthy Adults 50 Years of Age or Older.

∙ A Phase 1/2, Randomized, Single Ascending Dose Study in Adults (Stage  1) and Randomized, Single Ascending Dose-Finding Study (Stage 2) in  Elderly Subjects with ASP3772, a Pneumococcal Vaccine.

• Clostridium Difficile Vaccines

∙ A Phase 3, Placebo-Controlled, Randomized, Observer-Blinded Study To  Evaluate The Efficacy, Safety, And Tolerability Of A Clostridium Difficile  Vaccine In Adults 50 Years Of Age And Older.

∙ A Phase 2, Placebo-Controlled, Randomized, Observer-Blinded Study To  Evaluate The Safety, Tolerability, And Immunogenicity Of Two 3-Dose  Regimens Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 To  85 Years.

∙ A Phase 3, Randomized Observer-Blinded Study To Evaluate The  Immunogenicity, Safety, And Tolerability Of 2 Doses Compared To 3  Doses Of Clostridium Difficile Vaccine In Adults 50 Years Of Age And  Older.

• Other Vaccines

∙ A Phase 3 Safety, Immunogenicity, and Lot-Consistency Trial of the VLP Based Chikungunya Vaccine PXVX0317 in Healthy Adults and  Adolescents.

∙ A Phase 3, International, Multi-center, Randomized, Double-blind,  Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity,  and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle  Vaccine, in the Prevention of Oral Persistent Infection With HPV Types  16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of Age.

∙ A Phase I/II Observer-blind, Randomized, Placebo-controlled, Multi center Trial to Evaluate the Safety and Immunogenicity of Different  Formulations of Monovalent Influenza A/Hong Kong/125/2017-like (H7N9)  Virus Vaccine With AS03 Adjuvant System, Given as a Two-dose Series  to Adults 18 to 64 Years of Age and 65 Years of Age and Older.

∙ A Phase 2b, Placebo-Controlled, Randomized, Observer-Blinded Trial To  Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tetanus, Diphtheria, And Acellular Pertussis Vaccine (Tdap) In Healthy  Nonpregnant Women 18 Through 49 Years Of Age.

Women Health

∙ Phase 3 Double-blind Placebo-controlled Efficacy Trial of EVO100  Vaginal Gel for the Prevention of Urogenital Chlamydia Trachomatis and  Neisseria Gonorrhoeae Infection

∙ Phase 2B Double-blind Placebo-controlled Efficacy Trial of EVO100  (Previously Known as Amphora ® Gel) for the Prevention of Acquisition of  Urogenital Chlamydia Trachomatis Infection.

∙ AMPOWER A Single-arm, Phase III, Open Label, Multi-center, Study in  Women Aged 18-35 Years of the Contraceptive Efficacy and Safety of Phexxi™ (Previously Referred to as AMPHORA®) Contraceptive Vaginal  Gel.

∙ A Randomized Double-blind Placebo Controlled Phase 3 Trial to Evaluate  the Efficacy and Safety of Estetrol for the Treatment of Moderate to  Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort  Study II).

∙ A Phase 3, Multicenter, Open-Label, Single Arm Study of MR-100A-01 in  Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety.

∙ A Single-arm, Open-label, Multicenter Phase 3 Study of the Contraceptive Efficacy, Safety and Tolerability of the AG200-15 Transdermal  Contraceptive Delivery System (TCDS).

• Migraine

∙ A Phase 2/3 Randomized, Double-Blind, Placebo Controlled Study to  Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine  Prevention.

∙ Phase 3, Multicenter, Randomized, Double-blind,Group Sequential,  Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant or  the Treatment of Migraine (With or Without Aura) in Children and  Adolescents ≥ 6 to

∙ A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to  Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention.

∙ A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study  to Evaluate the Efficacy and Safety of Eptinezumab Administered  Intravenously in Subjects Experiencing an Acute Attack of Migraine.

∙ A Randomized, Double-Blind, Parallel Group, Placebo-Controlled,  Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of  Single Doses of STS101 (Dihydroergotamine Nasal Powder) in the Acute  Treatment of Migraine.

∙ A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to  Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention.

∙ A Prospective, Randomized, Vehicle-Controlled, Double-Blind, Phase 2  Study to Assess the Safety, Tolerability, and Efficacy of B244 Delivered  as an Intranasal Spray for Preventive Treatment in Subjects With  Episodic Migraine.

∙ Phase 3, Double-Blind, Randomized, Placebo Controlled, Safety and  Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet  (ODT) for the Acute Treatment of Migraine.

∙ Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and  Efficacy Trial of BHV-3000 (Rimegepant) for the Acute Treatment of  Migraine.

∙ A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to  Evaluate the Efficacy and Safety of ALD403 Administered Intravenously  in Patients With Frequent Episodic Migraines.

∙ A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase  3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered  Intravenously in Patients With Chronic Migraine.

• Metabolic/Endocrinology

∙ A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, 3-Arm,  Parallel Group Study To Evaluate Safety, Tolerability And

Pharmacodynamics Of Pf-06835919 Administered Daily For 16 Weeks In Adults With Non-Alcoholic Fatty Liver Disease And Type 2 Diabetes  Mellitus On Metformin.

∙ A 12-week Randomized, Patient and Investigator Blinded, Placebo controlled, Parallel Group Study to Investigate the Efficacy of LIK066 in  Obese Patients With Non-alcoholic Steatohepatitis (NASH).

∙ A Randomized, Double-blind, Placebo-controlled, Parallel-group,  Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea Alone or in Combination With Metformin in  Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control  on a Sulfonylurea Alone or With Metformin.

∙ A Randomized, Double-blind, Placebo-controlled, Parallel-group,  Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin as Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have  Inadequate Glycemic Control.

∙ A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator  Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of  Sitagliptin Compared With the Addition of Dapagliflozin in Subjects With  Type 2 Diabetes Mellitus and Mild Renal Impairment Who Have  Inadequate Glycemic Control on Metformin With or Without a

Sulfonylurea.

∙ A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week  Multicenter Study With a 78-Week Extension To Evaluate The Efficacy  And Safety Of Ertugliflozin In Subjects With Type 2 Diabetes Mellitus And  Inadequate Glycemic Control On Metformin Monotherapy.

∙ A 24-week International, Multicenter, Randomized, Open-Label, Active Controlled, Parallel Group, Phase 3b Trial With a 28-week Extension to  Evaluate the Efficacy and Safety of Saxagliptin Co-administered With  Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2  Diabetes Who Have Inadequate Glycemic Control on Metformin With or  Without Sulfonylurea Therapy.

∙ A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled  Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric  Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic  Control.

• Cardiovascular

∙ A Randomized, Double Blind, Multicenter, Multinational, Placebo  Controlled, Parallel Group, Single Dose, Adaptive Efficacy and Safety Study of Glenzocimab Used as an add-on Therapy on Top of Standard of  Care un the 4.5 Hours Following an Acute Ischemic Stroke.

∙ A 52 Week, Open Label Evaluation of the Effects of Sacubitril/Valsartan  (LCZ696) Therapy on Biomarkers, Myocardial Remodeling and Patient reported Outcomes in Heart Failure With Reduced Left Ventricular  Ejection Fraction.

∙ A Multicenter, Randomized, Double-blind, Active-controlled Study to  Evaluate the Effects of LCZ696 Compared to Valsartan on Cognitive  Function in Patients With Chronic Heart Failure and Preserved Ejection  Fraction.

∙ A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging  Multicenter Study to Evaluate the Efficacy and Safety of ALN-AGT01 in  Patients With Mild-to-Moderate Hypertension.

• Other Therapeutic areas

∙ Testosterone Replacement Therapy for Assessment of Long-term  Vascular Events and Efficacy Response in Hypogonadal Men  (TRAVERSE) Study.