Clinical Development Lead - Remote

3+ years

$45 to $95 per hour

Pleasanton Remote, USA

10 July 31, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Development Lead, Infection and Immunity

Location: Remote (Please indicate candidate's location on the resume)

Basic Functions and General Scope: The Clinical Development Lead, Infection and Immunity, is responsible for guiding the development of new laboratory and digital diagnostic products in the fields of infectious diseases and immunology at [Client's Diagnostic Solutions]. This role involves identifying unmet medical needs, defining clinical requirements, and leading the clinical development and validation strategies to achieve regulatory approval for new In Vitro Diagnostics products.

This position may be based in Pleasanton, California, USA, with the possibility of remote work. The incumbent will report to the Head of Clinical Development, Infection and Immunity, within the Clinical Development and Medical Affairs department. While this role does not have direct reports, it requires leadership of cross-functional teams and mentoring junior members to foster individual development within the organization.

Specific Responsibilities:

Serve as a medical leader and expert, keeping the company informed of advances in clinical medicine, health systems, and public health in infectious diseases and immunology.
Identify areas of unmet medical need for diagnostic products.
Lead exploratory studies to guide product development and generate intellectual property.
Define potential clinical utility claims for products, provide medical/scientific input, and assist with regulatory submissions and responses to regulatory agency inquiries.
Collaborate with Research and Development groups on target product profiles, design choices, and performance verification experiments, and review clinical data.
Develop product specifications to ensure safety, effectiveness, and clinical utility.
Work with Clinical Operations to design, implement, interpret, report, and publish clinical research studies supporting product registrations. Identify and engage academic partners, external laboratories, and clinical sites.
Present research findings at meetings and in publications.
Provide clinical expertise for medical risk and safety assessments.

Position Requirements:

Graduate work in microbiology, virology, or immunology; MD and/or PhD preferred.
1+ years of clinical research experience with thorough knowledge of clinical trial design and statistical methods. More experience preferred.
Proven ability to design clinical trials, critically evaluate study results, and write protocols, study reports, and publications.
Understanding of laboratory techniques in infectious diseases, such as PCR, sequencing, serology, microbiology, and clinical virology.
Excellent organizational, communication, and project management skills.
Experience interfacing with key opinion leaders, including physicians and clinical laboratorians.

Preferred Qualifications:

3+ years of clinical experience in infectious diseases clinical care or medical microbiology/virology. Board certification is a plus.
Laboratory work experience.
Expertise in epidemiology, biostatistics, implementation science, or other public health areas.
Experience in the diagnostics, medical device, or pharmaceutical industries, with a track record of regulatory approval based on clinical trials.
Experience in developing clinical software.
Expertise in clinical areas such as immunocompromised host, HIV, transplant, sepsis, hepatitis, respiratory infections, or clinical immunology.

About Maxis Clinical Sciences: Maxis Clinical Sciences provides comprehensive solutions for Clinical and Digital Services, recognized for its integrated research competence center. Operating globally, Maxis offers 24×7 delivery with teams across North America, Europe, and Asia, promoting genuine relationships and steady communication. Maxis specializes in clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting, data anonymization, and RWD aggregation and curation services.

For more information, visit www.maxisclinical.com.

Latest Jobs

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Arkansas :

Fort Smith |

Kington :

Frank Scottile Blvd |

Missouri :

Fulton | Milan | St. Louis |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Nebraska :

Hebron | Nebraska City |

Hawaii :

Hilo | Honolulu |

Tennessee :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

Lisbon | Oeiras | Portugal |

WI :

Madison | Wausau |

Republic of Mexico :

Mexico |

northeastern :

New Hampshire |

Oklahoma :

Oklahoma City |

Puerto Rico :

San Juan |

Albama :

Tuscaloosa |

D.C :

Washington |

Delaware :

Wilmington |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Germany :

Germany | GErmany |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Saxony Anhalt :

Halle |

Rotherbaum :

Hamburg |

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Schleswig Holstein :

Kiel |

Berlin :

Mitte |

Mecklenburg Vorpommern :

Rostock |

Saarland :

Saarbrucken |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

Tipperary :

Ballydine |

Cork :

Brinny | Ringaskiddy |

Carlow :

Carlow |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Meath :

Dunboyne |

Dún Laoghaire :

Dún Laoghaire |

Galway :

Galway |

County Dublin :

Swords |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

Pharma Jobs in Canada & Belgium & South America & Greece & New Zealand & Austria & Spain & Philippines & Croatia & Estonia & Vietnam & Italy & Indonesia & Japan & Finland & Korea & Kazakhstan & Thailand & Israel & Remote & Colombia & Tennessee & Romania & Argentina & Egypt & Mexico & United Arab Emirates & Saudi Arabia & malaysia & Ukraine & Peru & France & South Afrcia & Serbia & Czechia & Chile & Bosnia and Herzegovina & Singapore & Bulgaria & Sweden & Taiwan & Poland

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Argentina | Peru |

Brazil :

Brazil | Sao paulo |

Attica :

Koropi | Athens |

Greece :

Greece |

North Island :

Auckland |

New Zealand :

New Zealand |

Austria :

Austria |

Vienna :

Vienna |

Catalonia :

Barcelona |

Madrid :

Madrid |

Cebu Province :

Cebu City |

Philippines :

Manila |

Croatia :

Croatia |

Zagreb :

Zagreb |

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Japan | Saitama |

Tokyo :

Otemachi |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

New Mexico | Ciudad de México |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Paris | Lyon |

South Africa :

South Africa | Midrand |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Clinical Development Lead - Remote

Job Description

Job Title: Clinical Development Lead, Infection and Immunity

Latest Jobs

Medical Review Officer

Senior Medical Safety Analyst - Nutrition - Columbus

Associate Clinical Site Lead

Clinical Site Lead - Los Angeles

Medical Director, Crm Medical Affairs

Patient Therapy Access Specialist