director of scientific research

The Lockwood Group

<div>This position can be based remotely (working from home) or at our headquarters in Stamford, CT.

About Lockwood: Lockwood collaborates with clients in the pharmaceutical, biotech, and medical device industries to identify effective, holistic, science-based strategies to address their objectives through medical communications. Our clients count on us to challenge their assumptions and help them creatively navigate around obstacles. From strategy through execution, we focus on accuracy, transparency, and scientific value to create programs that are evidence-based, clinically relevant, and contribute to the development of our clients&rsquo; brands. Over a third of our staff hold advanced scientific or medical degrees, and most work from where they live. Because our flexible structure provides better work-life balance, we attract the best talent, facilitate their best work, and as a result, are more responsive to our clients, wherever and whenever they do business.

Summary: In this role, the Scientific Director is responsible for the planning, development, and oversight of scientific content for an assigned account or accounts across various therapeutic areas addressing different target audiences.

Responsibilities: Responsibilities include working with the Group Scientific Director to provide clients with strategic medical communication recommendations that support the achievement of brand goals, independently leading execution of content development activities, supervising Associate Scientific Directors, and liaising with other in-house or freelance staff to manage writing and other content-related tasks such as conducting background research, data-checking, and reference annotation.

Education: An advanced degree in science (ie. PhD, PharmD, or MD) is required. CMPP preferred.

Professional Skills and Requirements:
<ul>
<li>Candidates must have 5 or more years of relevant job experience with medical publications, including manuscripts, posters, abstracts, podium presentations, scientific platforms, and publication extenders.</li>
<li>This role requires demonstrated organizational, analytical, and interpersonal communication skills, as well as the ability to analyze and interpret scientific data, multitask, work independently, and manage projects within tight deadlines.</li>
<li>Experience with established professional medical editorial processes (ie. AMA style) and ethical guideline working knowledge (ie. ICMJE, GPP2022) is also required.</li>
<li>Experience with Heme/Oncology and solid tumors is a plus.</li></ul></div>

Scientific Director - Publications (Oncology)

<div>This position can be based remotely (working from home) or at our headquarters in Stamford, CT.

About Lockwood: Lockwood collaborates with clients in the pharmaceutical, biotech, and medical device industries to identify effective, holistic, science-based strategies to address their objectives through medical communications. Our clients count on us to challenge their assumptions and help them creatively navigate around obstacles. From strategy through execution, we focus on accuracy, transparency, and scientific value to create programs that are evidence-based, clinically relevant, and contribute to the development of our clients&rsquo; brands. Over a third of our staff hold advanced scientific or medical degrees, and most work from where they live. Because our flexible structure provides better work-life balance, we attract the best talent, facilitate their best work, and as a result, are more responsive to our clients, wherever and whenever they do business.

Summary: In this role, the Scientific Director is responsible for the planning, development, and oversight of scientific content for an assigned account or accounts across various therapeutic areas addressing different target audiences.

Responsibilities: Responsibilities include working with the Group Scientific Director to provide clients with strategic medical communication recommendations that support the achievement of brand goals, independently leading execution of content development activities, supervising Associate Scientific Directors, and liaising with other in-house or freelance staff to manage writing and other content-related tasks such as conducting background research, data-checking, and reference annotation.

Education: An advanced degree in science (ie. PhD, PharmD, or MD) is required. CMPP preferred.

Professional Skills and Requirements:
<ul>
<li>Candidates must have 5 or more years of relevant job experience with medical publications, including manuscripts, posters, abstracts, podium presentations, scientific platforms, and publication extenders.</li>
<li>This role requires demonstrated organizational, analytical, and interpersonal communication skills, as well as the ability to analyze and interpret scientific data, multitask, work independently, and manage projects within tight deadlines.</li>
<li>Experience with established professional medical editorial processes (ie. AMA style) and ethical guideline working knowledge (ie. ICMJE, GPP2022) is also required.</li>
<li>Experience with respiratory medicine (pulmonary) is a plus.</li></ul></div>

Scientific Director - Publications (Pulmonary)

<div>This position can be based remotely (working from home) or at our headquarters in Stamford, CT.
<div>
<div><div><div><div><div><div><div>About Lockwood: Lockwood collaborates with clients in the pharmaceutical, biotech, and medical device industries to identify effective, holistic, science-based strategies to address their objectives through medical communications. Our clients count on us to challenge their assumptions and help them creatively navigate around obstacles. From strategy through execution, we focus on accuracy, transparency, and scientific value to create programs that are evidence-based, clinically relevant, and contribute to the development of our clients&rsquo; brands. Over a third of our staff hold advanced scientific or medical degrees, and most work from where they live. Because our flexible structure provides better work-life balance, we attract the best talent, facilitate their best work, and as a result, are more responsive to our clients, wherever and whenever they do business.

Summary: In this role, the Scientific Director is responsible for the planning, development, and oversight of scientific content for an assigned account or accounts across various therapeutic areas including Rare Disease addressing different target audiences.

Responsibilities: Responsibilities include working with the Group Scientific Director to provide clients with strategic medical communication recommendations that support the achievement of brand goals, independently leading execution of content development activities, supervising Associate Scientific Directors, and liaising with other in-house or freelance staff to manage writing and other content-related tasks such as conducting background research, data-checking, and reference annotation.

Education: An advanced degree in science is required.

Professional Skills &amp; Experience:
<ul>
<li>Candidates must have 5 or more years of relevant job experience with promotional medical education content such as advisory boards, speaker programs, slide decks, etc.</li>
<li>This role requires demonstrated organizational, analytical, and interpersonal communication skills, as well as the ability to analyze and interpret scientific data, multitask, work independently, and manage projects within tight deadlines with limited direction.</li>
<li>Experience with established professional medical editorial processes (eg, AMA style) and ethical guidelines is also required.</li>
<li>Experience with Oncology / Hematology preferred.</li></ul></div></div></div></div></div></div></div></div></div>

Scientific Director - MedEd (Oncology + Commercial)

Merck

<div>Job Description
Job Description:
The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Immunology therapeutic area. Our company's Immunology medicines span all phases of clinical development (pre-clinical to post-licensure). The Clinical Director may manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
Role Responsibilities:
Specifically, the Clinical Director may be responsible for:<ul><li>
Planning clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy</li><li>
Medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs</li><li>
Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication</li><li>
Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds</li><li>
Supporting business development assessments of external opportunities</li></ul>
The Clinical Director may:<ul><li>
Actively engage with other functional areas in support of study execution</li><li>
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and</li><li>
Assist the team in ensuring that other colleagues are informed of the progress of studies of our company and competitors' drugs, and</li><li>
Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility.</li></ul>
The Clinical Director is responsible for maintaining a strong scientific fund of knowledge by:<ul><li>
Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies</li><li>
Identifying scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs</li><li>
Establishing communications with prominent clinical investigators in their particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs</li><li>
Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.</li></ul>
To accomplish these goals, the Clinical Director may:<ul><li>
Author detailed development documents, presentations, budgets, and position papers for internal and external audiences</li><li>
Facilitate collaborations with external researchers around the world</li><li>
Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.</li></ul>
Education:<ul><li>
M.D or M.D./Ph.D.</li></ul>
Required Experience and Skills:<ul><li>
Must have experience in industry or senior faculty in academia</li><li>
Minimum of 3 years of clinical medicine experience</li><li>
Minimum of 1 year of industry experience in drug development or biomedical research experience in academia</li><li>
Demonstrated record of scientific scholarship and achievement</li><li>
Proven track record in clinical medicine and background in biomedical research</li><li>
Strong interpersonal skills, as well as the ability to function in a team environment</li><li>
Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility.</li></ul>
Preferred Experience and Skills:<ul><li>
Board Certified or Eligible in Rheumatology or related discipline</li><li>
Prior specific experience in clinical research and prior publication</li></ul>
Required Skills:
Allergy and Immunology, Clinical Development, Clinical Documentation, Clinical Immunology, Clinical Medicine, Clinical Reporting, Clinical Research, Clinical Trial Planning, Clinical Trials, Clinical Trial Support, Drug Development, Ethical Standards, Leadership, Regulatory Requirements, Rheumatology
Preferred Skills: 
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another&rsquo;s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as &ldquo;remote&rdquo;.
The salary range for this role is
$255,800.00 - $402,700.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee&rsquo;s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles&rsquo; Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully 
Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/5/2026<ul><li>A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. 
</li></ul> 
Requisition ID:R389093</div>

Clinical Director (Principal Scientist), Clinical Research, Immunology - Rheumatology

American Museum

<div><h2 class="jobSectionHeader">Posting Details</h2>
<div><div><div>Position Information
</div><div><div><div><div>Position Title</div> <div>Assistant Director, Donor Communications</div>
</div> 
<div><div>Department</div> <div>Advancement - 130</div>
</div> 
<div><div>Position Summary</div>
<div><div>The American Museum of Natural History is one of the world&rsquo;s preeminent scientific and cultural institutions, and has as its mission to discover, interpret, and disseminate information about human cultures, the natural world, and the universe through a wide-ranging program of scientific research, education, and exhibition. 
 
The Advancement department is seeking a full-time Assistant Director, Donor Communications. 
 
A skilled writer and collaborative team member, the Assistant Director excels at shaping stories from across the Museum that demonstrate both the significance of the Museum&rsquo;s work and the opportunities for donor support to deepen that impact. 
 
Responsible for creating donor-facing materials, the Assistant Director partners directly with frontline fundraisers, Advancement leadership and colleagues across the Museum to gather information, develop donor communications materials and manage these projects from concept through completion. This position requires strong writing and editing abilities, attention to detail and the ability to manage multiple projects simultaneously while meeting deadlines. The ideal candidate understands how compelling storytelling drives philanthropic engagement. 
 
Job duties include, but are not limited to:</div><ul>
<li>Translate complex institutional initiatives, scientific research and programmatic work into clear, engaging language for donor audiences. Develop and write original donor-facing communications, including impact briefs, program summaries, pitch presentations, talking points, donor newsletters, website copy and other Advancement materials highlighting the Museum&rsquo;s work and the role of philanthropy.</li>
<li>Research and gather information from programmatic departments, scientists, educators and others across the Museum to identify and develop compelling stories about institutional initiatives, strategic priorities and the impact of philanthropy.</li>
<li>Collaborate with frontline fundraisers to develop coordinated evergreen and communications materials for cultivation, solicitation and stewardship activities.</li>
<li>Edit and refine communications materials to ensure clarity, accuracy and alignment with institutional branding, writing and visual standards, partnering closely with other departments. Collaborate with the Director to develop and ensure consistency with templates, guidelines and messaging.</li>
<li>Manage multiple donor communications projects simultaneously with Advancement partners, tracking project timelines, feedback and revisions to meet deadlines and ensure alignment.</li>
<li>Maintain organized systems for drafts, approvals and final materials while refining donor communications best practices and workflows.</li>
<li>Staff periodic Advancement events in the evening or on weekends, as needed.</li> 

</ul><div>
 
The expected salary range for the Assistant Director, Donor Communications is $80,000/annual &ndash; $90,000/annual. The AMNH offers an extensive benefits package designed to meet the needs of our dedicated and diverse community. 
 
Pay will be determined based on several factors. The hiring range for the position at commencement is based on the type of work and the scope of responsibilities. The salary and placement offered is based on a number of individualized factors, including, but not limited to, skills, knowledge, training, education, credentials, areas of specialization and depth and scope of experience.</div></div>
</div> 
<div><div>Minimum Qualifications</div>
<ul><li>Bachelor&rsquo;s degree in English, communications, museum studies, a field aligned with this position&rsquo;s mission (e.g., anthropology, science) or another related field.</li>
<li>Five years progressively responsible experience in advancement communications, donor relations, development or another related field.</li>
<li>Exceptional writing, editing and proofreading skills, including the ability to shift writing style to fit purpose, audience, voice and tone.</li>
<li>Demonstrated experience in project management, project planning and time management.</li>
<li>Excellent analytical skills including the ability to critically examine information and ask probing questions.</li>
<li>Fluency in the Microsoft Office Suite.</li>
</ul>
</div> 
<div><div>Preferred Qualifications</div>
<ul><li>Experience working in communications, marketing or writing in an advancement/development office at a nonprofit or cultural institution.</li>
<li>Proficiency working with design software such as Photoshop, InDesign or Canva.</li>
</ul>
</div> 
<div><div>Physical Demands</div>
<ul><li>Must be able to remain in a stationary position (sitting or standing) for prolonged periods.</li>
<li>Must be able to move about the Museum campus.</li>
</ul>
</div> 
<div><div>Category</div> <div>Full-Time</div>
</div> 
<div><div>Total Number of Scheduled Hours Per Pay Period</div> <div>70</div>
</div> 
<div><div>Union Status</div> <div>Non-Union</div>
</div> 
<div><div>FLSA</div> <div>Exempt</div>
</div> 
<div><div>Expected Salary Minimum</div> <div>$80,000/annual</div>
</div> 
<div><div>Expected Salary Maximum</div> <div>$90,000/annual</div></div></div></div></div></div></div>

Assistant Director, Donor Communications

TetraScience

<div>About TetraScience
TetraScience is the Scientific Data and AI Company building Tetra OS, the operating system for scientific intelligence. We help the world&rsquo;s leading life sciences firms turn fragmented scientific data into AI-native assets and scientific workflows that accelerate discovery, development, and manufacturing. TetraScience&rsquo;s growing ecosystem of strategic partners includes NVIDIA, Databricks, Thermo Fisher Scientific, Snowflake, Google, and Microsoft.
In connection with your candidacy, you will be asked to carefully review The Tetra Way authored by our CEO, Patrick Grady; it is impossible to overstate the importance of this document, and you should take it literally as you decide whether our mission, culture, and expectations are right for you. 
The Role
The Customer Delivery Director is the operational heartbeat of the TetraScience account team after landing a new customer or expanding the relationship with an existing customer. Where the Scientific Solutions Partner (SSP) wins the vision and the Technical Delivery Director (TDD) sets the technical implementation strategy, the Customer Delivery Director ensures that vision becomes reality &mdash; on time, on scope, and ahead of schedule. Both the SSP &amp; Delivery roles share accountability for identifying and progressing expansion opportunities within their accounts.
The profile we are looking for is best described by a specific phenotype such as top tier consultants who went deep into biopharma. Someone who has lived inside these organizations, understands their political and procurement complexity, and knows how to clear the blockers &mdash; SSO, IT governance, vendor approval &mdash; that stall lesser implementations. At TetraScience, delivering on the contract ahead of schedule and showing value is the renewal and expansion strategy. Successful delivery always delivers scientific value as quickly as possible - TetraScience is not a service provider, we provide scientific outcomes.
This role owns the end-to-end delivery lifecycle for a portfolio of enterprise biopharma and life sciences customers, managing implementations &amp; adoption of the Tetra Scientific Data Foundry and Tetra OS across the full medallion data architecture (bronze silver gold). The Customer Delivery Director is a trusted operational partner to the customer, bridging internal TetraScience teams (engineering, professional services, product, science) with diverse customer stakeholders to drive measurable outcomes.
This is not a project coordination role. The Customer Delivery Director is scientifically literate, politically adept, and commercially strategic &mdash; and capable of proactively identifying and closing risk across all three dimensions. In addition to delivery the Customer Delivery Director will be relentlessly connecting the dots to identify the next expansion opportunities at all times.
TetraScience provides its Customer Delivery Directors with AI-powered tools &mdash; including Claude Cowork and Codex &mdash; that automate status reporting, triage, and contracting workflows, enabling each DM to manage a broader portfolio without sacrificing delivery quality. 
What You&rsquo;ll Do
Delivery Execution<ul><li>
Own end-to-end program delivery for a portfolio of enterprise customers, including implementation of instrument connectivity, Tetra OS data pipeline configuration (bronze/silver/gold), and scientific use case enablement &amp; adoption.</li><li>
Navigate the full complexity of enterprise pharma delivery environments: SSO provisioning, IT security reviews, validation hurdles, procurement workflows, and change control processes &mdash; clearing blockers proactively so that go-live happens ahead of schedule, not behind it</li><li>
Hold the delivery pace even when the customer isn't pressing. Look around corners for timeline drag and scope creep, and resolve them through direct action or by identifying &amp; moving the customer stakeholders who can unblock.</li><li>
Lead project kick-off, milestone tracking, resource planning, scope management, and project closure across multiple concurrent workstreams</li><li>
Manage and document change requests, ensuring scope changes are assessed, approved, and communicated with minimal disruption to timelines</li><li>
Maintain rigorous delivery governance: roles, responsibilities, decision rights, and escalation paths</li><li>
Coordinate internal teams, external vendors, customer stakeholders and management on both sides to ensure effective scientific outcomes.</li></ul>
Customer Account Management<ul><li>
Serve as the primary operational point of contact for customer delivery stakeholders (Lab IT, informatics, project management, and scientific leads)</li><li>
Navigate customer political dynamics with fluency &mdash; building trust across scientific, IT, and procurement stakeholders simultaneously</li><li>
Run structured customer update meetings, steering committees, and executive delivery reviews</li><li>
Proactively manage risks and customer expectations; surface issues early and drive to resolution before they become escalations</li><li>
Ensure successful customer handoff from implementation to steady-state, with clear documentation and success criteria met</li></ul>
Commercial Strategy<ul><li>
Hold the delivery pace even when the customer isn't pressing. Look around corners for timeline drag and scope creep, and resolve them through direct action or by identifying &amp; moving the customer stakeholders who can unblock.</li><li>
Partner with Scientific &amp; IT leaders to build and surface the customer's value realization story throughout the engagement: quantify scientific outcomes, translate them into ROI language senior budget owners will accept, and make that story visible to decision makers well before renewal windows open.</li><li>
Actively develop expansion pipelines (additional instruments, labs, use cases, sites, adjacent scientific workflows). Shape the commercial case jointly with the Scientific Solutions Partner and drive qualified opportunities into the account plan.</li><li>
Feed delivery intelligence into account strategy: stakeholder dynamics, unmet needs, political landscape, competitive signals. Advise with the SSP on timing and sequencing of expansion plays.</li></ul>
Internal Collaboration<ul><li>
Coordinate cross-functional TetraScience resources &mdash; scientific data engineers, technical architects, product &mdash; to meet delivery commitments</li><li>
Escalate technical issues to the Technical Delivery Director with clear context and business impact framing</li><li>
Contribute to continuous improvement of TetraScience&rsquo;s delivery methodology, templates, and tooling</li></ul> 

Requirements 
What You Bring<ul><li>
Advanced degree in a life science, chemistry, or engineering discipline preferred; equivalent practical experience considered</li><li>
5-7+ years in management consulting (top-tier firm strongly preferred), enterprise SaaS delivery, or life sciences commercial program management &mdash; with direct experience inside or serving large biopharma organizations</li><li>
2-4+ years life sciences laboratory research experience (advanced academia or industry) having deep familiarity with laboratory workflows and data: you understand what it means when a customer has 50 instruments generating unstructured data that no one can analyze</li><li>
Strong executive presence &mdash; equally compelling in a whiteboard architecture session and a C-suite business case conversation</li><li>
A track record of navigating complex enterprise environments &amp; demonstrated ability to influence without direct authority: you know how to move procurement, IT security, and change control without losing momentum</li><li>
Fluency with scientific data concepts: file formats, instrument connectivity, data harmonization, and the path from raw data to AI-ready datasets</li><li>
Political fluency in large pharma: you build trust across scientific, IT, and procurement stakeholders simultaneously, and you know when to push and when to wait</li><li>
Proficiency with project management tools (Jira, Smartsheet, MS Project, or similar); familiarity with agile and waterfall methodologies</li><li>
A builder, not just a user of AI. Has turned modern AI tools into operational workflows that measurably speed up their own work and the team's.</li><li>
PMP, CSM, or equivalent certification preferred</li><li>
Ability to travel to customer sites for key delivery milestones routinely flexing based on specific account needs (baseline expectation 1x weekly)</li></ul> 

Benefits 
<ul><li>
100% employer-paid benefits for all eligible employees and immediate family members</li><li>
Unlimited paid time off (PTO)</li><li>
401K</li><li>
Flexible working arrangements - Remote work</li><li>
Company paid Life Insurance, LTD/STD</li><li>
A culture of continuous improvement where you can grow your career and get coaching</li></ul>
We are not currently providing visa sponsorship for this position</div>

Customer Delivery Director- Bay Area

Sanofi

<div>Job title: Clinical Research Director - Rare Diseases
Location: Cambridge, MA / Morristown, NJ
About the Job
Join the engine of Sanofi&rsquo;s mission &mdash; where deep immunoscience meets bold, AI-powered research. In R&amp;D, you&rsquo;ll drive breakthroughs that could turn the impossible into possible for millions.
The Clinical Research Director (CRD), Rare Diseases Therapeutic Area, is responsible for creation and execution of the clinical development strategy for assigned projects/studies in this Therapeutic Area (TA). The CRD is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge and lead clinical study development in alignment with the asset scientific and business strategy. The role will support developing innovative therapies, particularly with an initial focus in the pulmonary space. The CRD is expected to contribute to the growth of the Rare Blood Disorders TA by both being a driver of clinical and scientific knowledge and advancing operational capabilities.
About Sanofi 
We&rsquo;re an R&amp;D-driven, AI-powered biopharma company committed to improving people&rsquo;s lives and delivering compelling growth. Our deep understanding of the immune system &ndash; and innovative pipeline &ndash; enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people&rsquo;s lives. 
Main Responsibilities:<ul><li>
Create clinical development strategy and plans for one or more assets</li><li>
Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies</li><li>
Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing</li><li>
Advance the clinical development plan through internal management review</li><li>
Lead a clinical sub team to design clinical studies and to create study protocols</li><li>
Execute the clinical development plan in close collaboration with clinical operations</li><li>
Advance scientific and clinical knowledge in rare diseases</li><li>
Incorporate new trial, scientific and digital methodologies</li><li>
Pro-actively progress study execution</li><li>
Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations</li><li>
Review documents supporting clinical development such as Investigator&rsquo;s brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval</li><li>
Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews)</li><li>
Serve as a medical expert and provide strategic input to early-stage programs
</li><li>Collaborate with external experts, key opinion leaders, and investigators to advance clinical research</li><li>
Represent Sanofi at scientific conferences and regulatory meetings</li></ul>
Scientific and Technical Expertise:<ul><li>
Has and maintains deep scientific, technical and clinical expertise in the therapeutic area</li><li>
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest</li><li>
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products</li><li>
Maintains visibility within the Therapy therapeutic area to maintain credibility with internal and external stakeholders</li></ul>
On Clinical Development, the CRD:<ul><li>
Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes</li><li>
Assessment of the Clinical benefit &ndash;risk profile during development and LCM on an ongoing basis, in strong collaboration with GPE and the CSO team</li><li>
Provides clinical input to the Target Product Profile</li><li>
Adjusts and updates the clinical strategy when necessary according to the project progression and information available</li><li>
Contributes to the life cycle management strategy for the project whenever appropriate</li></ul>
The CRD is representative for Clinical Development:<ul><li>
at the Project Team</li><li>
in meetings with Regulatory Agencies</li><li>
in Steering Committees (SC) and Data Monitoring Committees (DMC)</li><li>
at the Benefit Risk Assessment Committee</li><li>
at the Submission Task Force. Provides clinical input and reviews the product information (Summary of Product Characteristics or equivalent)</li></ul>
The CRD generates documents:<ul><li>
Generates the Clinical Development Plan</li><li>
Prepares the clinical part of meeting requests and briefing packages for meetings with Regulatory agencies</li><li>
Generates the extended synopsis for clinical trials and reviews the protocols and protocol amendments prepared by the Clinical Study Director (CSD)</li><li>
Writes or updates the clinical section of the Clinical Investigator Brochure and the clinical parts of the Clinical Trial Authorization dossier (IMPD, IND) in collaboration with the pharmacovigilance (GPE) department and the clinical pharmacologist</li><li>
Reviews and when appropriate approves the committees charters</li><li>
Prepares with the support of the medical writing department the summary of clinical efficacy and clinical overview of the Common Technical Document (CTD). Provide input and reviews all clinical sections of the CTD (clinical pharmacology, summary of clinical safety&hellip;) and other sections whenever appropriate</li><li>
Prepares answers to questions from Regulatory Agencies on the clinical efficacy of the project and collaborates with GPE in preparing answers on the clinical safety of the project, collaborates on other sections whenever appropriate</li><li>
In charge of the medical/clinical assessment of license-in opportunities</li></ul>
About You
Experience / Skills:<ul><li>
MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization</li><li>
Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia)</li><li>
Have experience in novel approaches to translational medicine</li><li>
Demonstrate problem solving skills</li><li>
Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area</li><li>
Strong leadership skills with the ability to influence and collaborate effectively in a matrix environment</li><li>
Excellent communication and presentation skills, with the ability to articulate complex scientific concepts to diverse audiences</li><li>
Proven track record of scientific publications and presentations at international conferences</li></ul>
Why Choose Us?<ul><li>
Bring the miracles of science to life alongside a supportive, future-focused team.</li><li>
Discover endless opportunities to grow your talent and drive your career, whether it&rsquo;s through a promotion or lateral move, at home or internationally.</li><li>
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.</li><li>
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks&rsquo; gender-neutral parental leave.</li></ul>
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.</div>

Clinical Research Director - Rare Diseases

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