This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio.

The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment.

PRIMARY RESPONSIBILITIES: 

• Study Design and Statistical Strategy: Lead the statistical design and analytical planning for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. Propose and justify efficient study designs tailored to complex oncology use cases.

• Cross-Functional Collaboration: Serve as study statistician for multiple studies. Collaborate with clinical, medical, and translational partners to influence study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.

• Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders. 

• Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor.  Collaborate on manuscripts for publications.

QUALIFICATIONS: 

• Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).

• 4+ years of experience in clinical trial biostatistics.

• Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.

• Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.

• Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).

• Proficient in R.

KNOWLEDGE, SKILLS, AND ABILITIES: 

• Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges.

• Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation.

• Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.

• Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.

Preferred qualifications: 

• Working-knowledge of NGS-based diagnostics and ctDNA/MRD.
• Experience with non-inferiority studies.

This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio.

The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment.

PRIMARY RESPONSIBILITIES: 

• Study Design and Statistical Strategy: Lead the statistical design and analytical planning for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. Propose and justify efficient study designs tailored to complex oncology use cases.

• Cross-Functional Collaboration: Serve as study statistician for multiple studies. Collaborate with clinical, medical, and translational partners to influence study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.

• Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders. 

• Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor.  Collaborate on manuscripts for publications.

QUALIFICATIONS: 

• Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).

• 4+ years of experience in clinical trial biostatistics.

• Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.

• Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.

• Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).

• Proficient in R.

KNOWLEDGE, SKILLS, AND ABILITIES: 

• Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges.

• Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation.

• Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.

• Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.

Preferred qualifications: 

• Working-knowledge of NGS-based diagnostics and ctDNA/MRD.
• Experience with non-inferiority studies.

At Target RWE, our mission is driven by a deep commitment to people, whether it’s the patients we serve, the partners we collaborate with, or the dedicated team members who power our work. As a purpose-driven organization, we leverage real-world data to advance clinical research and inform better healthcare decisions. We foster a collaborative environment where every voice is heard, every idea has an impact, and every contribution helps improve lives. If you're seeking a place where your work truly matters, join us to advance science.

Overview

We are seeking a Principal to join Target RWE’s Quantitative Sciences (QS) organization. In this role, you will help shape how we design, execute, and communicate real-world clinical studies using Target’s data.

This is a highly cross-functional and client-facing role. You will bring strong analytical and scientific expertise, paired with the ability to apply the right level of methodological rigor for the question at hand, balancing credibility, practicality, and clarity. You will work closely with internal teams and external partners to ensure analyses are scientifically sound, clearly communicated, and aligned with real-world use cases.

You will serve as a key representative of Target’s scientific capabilities, engaging directly with pharmaceutical and biotech partners, supporting client discussions, and helping translate complex analytical approaches into clear, actionable insights.

What You’ll Do

Applied Methodology and Study Design

You will ensure that Target’s analyses are scientifically rigorous, practical, and aligned with real-world use.

• Guide the design of observational studies using real-world data, including retrospective and prospective analyses
• Apply statistical and epidemiologic methods in a practical, fit-for-purpose way
• Develop and review study protocols and statistical analysis plans
• Ensure analyses are reproducible, interpretable, and aligned with regulatory and scientific expectations
• Partner with internal teams to translate research questions into practical analytic approaches

Client-Facing Scientific Leadership

You will serve as a key scientific voice in client and partner interactions.

• Participate in and lead client meetings to explain study design, methodology, and results
• Translate complex analytical concepts into clear, accessible language for diverse audiences
• Support business development efforts by helping communicate Target’s scientific approach and data value
• Represent Target in external settings, including conferences, scientific collaborations, and partner discussions
• Build trust with clients by providing thoughtful, pragmatic, and credible scientific guidance

Cross-Functional Collaboration

You will connect data, analytics, and business needs across the organization.

• Partner closely with Product, Engineering, Medical Science, Clinical Operations, and Commercial teams
• Help shape analytic strategies that align with both scientific goals and customer needs
• Provide guidance to the Quantitative Sciences team on study design and interpretation
• Mentor team members on balancing methodological rigor with practical execution
• Contribute to internal best practices for scalable, high-quality evidence generation

What You’ll Bring

• PhD or MS in biostatistics, epidemiology, health economics, data science, or a related field
• 10+ years of experience working with real-world data (EMR, claims, registry, or clinical trial data)
• Strong foundation in observational study design and applied statistical methods; experience with real-world pragmatic clinical trial designs is a plus
• Demonstrated ability to apply methods pragmatically, selecting the right approach for the problem
• Willingness to engage directly with data and analyses as needed, with working knowledge of R and/or SQL to support exploratory work, validation, and collaboration with analytic teams
• Experience working directly with clients or external partners in life sciences or healthcare
• Excellent communication and presentation skills, with the ability to explain complex concepts clearly
• Comfortable operating in client-facing settings, including meetings, presentations, and scientific discussions
• Strong collaboration skills across technical and non-technical teams

What we offer you

• Hybrid work — 3 days/week in our brand-new office!
• Comprehensive health, dental, and vision for you and your family
• 401(k) with company match
• Generous PTO and company holidays
• Paid parental leave 

About the role: We are hiring frontline sales professionals to be part of a diverse and elite biopharma sales team dedicated to helping patients in need. With a laser focus on the eye care customer, the Territory Leader will be responsible for territory disease state education along with the launch and ongoing growth of XDEMVY. They will deliver high standards for the ongoing launch and beyond and will champion a culture of outstanding performance, compliance and full ownership of all activity and results. The Territory Leader will be experts in account management, business ownership, sales execution, resource utilization, and they will build and foster relationships with key eye care customers. The Territory Leader will relentlessly pursue excellence to maximize sales in their territory while learning to adapt to changes and needs of the business. In doing so, they will have the unique opportunity to meaningfully contribute to the growth and performance of Tarsus. This critical sales role will be ideal for someone who thinks strategically, operates with tactical precision and strives for excellence.

Geography: Candidates must live in Durham/Chapel Hill, Greensboro

Let’s talk about some of the key responsibilities of the role:

Account Management & Eye Care Experts

• Experts in eye care clinical information: anatomy, disease state, products, XDEMVY and office treatment patterns
• Experts in selling skills and account development including building relationships with all key stakeholders
• Experts in pull through tactics with a full understanding of managed care hurdles
• Understand all functions within an ophthalmology/optometry practice and how their roles impact product prescribing and pull through
• Maximize managed care opportunities within the territory and have an understanding of how it impacts the District, Region and Nation and share important feedback
• Understand key opinion leaders within respective geographies and foster engagement with Tarsus leadership
• As eye care experts, champion compliant promotion in alignment with our corporate values

Business Acumen & Sales Execution

• Drive top tier execution by exceeding sales performance goals and key productivity metrics across the territory
• Use expert analytical skills to guide highly productive activity – prioritize key customer engagements, drive reach and frequency to extend depth and breadth of product trial and utilization
• Drive a successful launch and ongoing performance by monitoring all key performance metrics weekly, monthly, quarterly, and annually – ability to adjust approach as needed based on data
• Ensure actionable business plans are set - align all selling activities to drive impact
• Share ongoing insights with leadership and internal stakeholders to ensure feedback is captured
• Personal accountability for driving the highest standards of ethics and compliance

Business Owners & Culture Champions

• Drive our culture of commitment, empowerment and teamwork which includes extreme ownership, high accountability, continuous improvement and relentless pursuit of excellence
• Achieve success and be prepared to adapt in a complex selling environment partnering with many stakeholders: district leaders, marketing, market access, medical affairs, sales ops, inside sales, training, and other important stakeholders
• Provide frontline feedback and intel to sales leadership and the broader organization
• Ensure PDMA compliance and adhere to all company & industry compliance guidelines
• Share ongoing best practices among peers and leadership to elevate national performance
• Maximize all key resources that lead to territory success

Factors for Success:

• Bachelor’s degree in business, science, or related field or commensurate experience
• 2+ years pharmaceutical sales / relevant healthcare sales experience or a proven track record of business to business sales - required
  • Proven track record of pharmaceutical launch experience - strongly preferred
  • Eye Care experience- preferred
• Established track record with evidence of excellent problem solving and collaboration
• Highly adaptable to change, able to quickly pivot and respond given new market information in a fast-paced environment
• Strong communication and change management skills
• Proven ability to escalate difficult issues and make tough decisions
• Established track record in the following job competencies:
  • Selling skills
  • High performance
  • Impact & influence
  • Customer focus & account management
  • Maximizing resources
  • Analytical skills
  • Relationship building
  • Decision making & judgment
  • Teamwork & collaboration
  • Adaptability & GRIT

A Few Other Details Worth Mentioning:

• This is a field-based position reporting to the District Sales Leader
• Geography: Candidates must live in Durham/Chapel Hill, Greensboro
• Travel will be required within the selling geography and beyond to sales meetings, possibly across various customer conventions and occasional travel to HQ in Irvine CA
• 40% - 50% travel required in some larger geographies
• Territory Leader Salary Range;
  • Associate Territory Leader – 2+ years proven B2B selling - $110,000
  • Territory Leader – 1-2 years pharma selling - $123,000
  • Territory Leader – 2-5 years pharma selling - $139,000    
  • Sr. Territory Leader – 5-8 years pharma selling - $145,000            
  • Sr. Territory Leader – 8+ years pharma selling - $161,000

At Tarsus, we understand the importance of attracting and retaining top talent. In addition to a competitive base pay, we offer an incentive bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Remote

About Us

Company Overview:

Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source. This honor demonstrates the company’s desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation.  Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.

This role is based on site in Winston Salem, North Carolina.

The Vice President, Quality and Regulatory will report to the Chief R&D Officer and will assume leadership of the following duties:

Job Overview: 

• Oversight and management of all quality systems. 

• Sign-off of batch and material release documentation. 

Essential Duties and Responsibilities: 

• Lead and evolve the CDMO’s Quality Compliance strategy for applicable GMP manufacturing operations, ensuring readiness for both clinical and commercial production. 

• Ensure full alignment with GMP, GLP, and GCP standards, which govern manufacturing, preclinical testing, and clinical‑trial‑related material production, respectively. 

• Ensure regulatory compliance across manufacturing, documentation, data integrity, and quality systems per globally recognized regulatory standards. 

• Oversee QA, QC, and Quality Systems, including deviations, CAPAs, change controls, risk management, stability oversight, and analytical method validation support. 

• Build a robust Quality Management System (QMS) aligned with CDMO best practices: SOP governance, GMP adherence, and ongoing process monitoring. 

• Partner closely with Technical Operations, Regulatory Affairs, and Analytical Development to ensure that process development, and manufacturing adhere to quality standards. 

• Support phase‑appropriate Quality/Regulatory needs including documentation, regulatory submissions, and quality governance. 

Qualifications: 

• Proven expertise in audit management, inspection readiness, CAPA governance, deviation management, and quality risk management systems. 

• Strong command of global regulatory frameworks, including expectations in data integrity, documentation, and GxP compliance. 

Education and/or Experience: 

• Advanced degree (Master’s or PhD) in Pharmaceutics, Biochemistry, Biochemical Engineering, Microbiology, or related life science fields preferred.  

• 20+ years of progressive Quality leadership experience in GMP‑regulated biologics/pharmaceutical manufacturing, including microbial or bacterial system experience. 

• Significant experience in clinical and commercial readiness, including scale‑up, process validation, regulatory inspections, and marketing ‑authorization support. 

Physical Demands:  

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

 Average travel for this position is 20% with some variations based on the demands of the business needs.

• Must be willing to travel to New York City office as needed.

Work Environment: 

 The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• No specific work demands.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Why You’ll Love Working at Protara

• Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.
• Company-wide dedication to profoundly impacting patients’ lives.
• Amazing culture whereby our core values and behaviors are shared cross-functionally.
• Flexible working hours/schedule.
• Generous Paid Holidays and Unlimited PTO.

Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws.

Company Overview:

Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source. This honor demonstrates the company’s desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation.  Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.

This role is required to be on site in Winston Salem, NC.

Job Overview: 

• Development and validation of analytical test methods. 

• Oversight of raw material, in-process and finished product testing. 

 Essential Duties and Responsibilities: 

• Act as the analytical lead for CDMO engagements, providing oversight of analytical method development, validation, transfer, and routine testing activities. 

• Lead phase‑appropriate analytical development strategies across the lifecycle, from early development through late‑stage / commercial programs. 

• Provide scientific leadership for analytical characterization, release, stability, comparability, and control strategies for biologics (drug substance, drug product, intermediates). 

• Build and oversee an analytical organization responsible for method development, qualification, validation, specifications, reference standard qualification, and stability program setup. 

• Oversee CDMO execution of QC testing, stability testing, reference standard/reagent programs, and analytical gap remediation. 

• Partner with process development, manufacturing, quality, regulatory, and supply chain to ensure analytical readiness for clinical and commercial manufacturing. 

• Provide analytical governance across internal and external teams, acting as a technical SME for drug substance (DS), drug product (DP), intermediates, and in‑process control. 

• Author, review, and contribute analytical content for regulatory submissions (IND, IMPD, CTA, BLA, MAA), including responses to health authority inquiries. 

 Qualifications: 

• Extensive experience in biologics analytical development, including method development, qualification/validation, and lifecycle management. 

• Deep understanding of analytical characterization techniques (purity, identity, potency, stability, CQAs) for microbial systems.  

• Demonstrated expertise supporting ilate‑stage (Phase 3/commercial) analytical programs. 

 Education and/or Experience: 

• Advanced degree (MS/PhD) in Analytical Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, or related field, consistent with analytical leadership roles in biologics 

• 10–20+ years of analytical development and QC experience in biologics, with increasing leadership responsibility 

Physical Demands:  

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

 Average travel for this position is 20% with some variations based on the demands of the business needs.

• Must be willing to travel to New York City office as needed.

Work Environment: 

 The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• No specific work demands.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Why You’ll Love Working at Protara

• Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.
• Company-wide dedication to profoundly impacting patients’ lives.
• Amazing culture whereby our core values and behaviors are shared cross-functionally.
• Flexible working hours/schedule.
• Generous Paid Holidays and Unlimited PTO.

Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws.

Company Overview:

Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source. This honor demonstrates the company’s desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation.  Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.

The Senior Director, Executive Director, Vice President,  Facility Oversight will report into the Chief R&D Officer. 

This role is based on site in Winston Salem, North Carolina.

Job Overview: 

• Oversight and management of facility operations and upgrades. 

• Oversight and management of facility testing and qualifications. 

 Essential Duties and Responsibilities: 

• Provide ongoing performance monitoring of key facility and operational KPIs across manufacturing sites, including schedule adherence, batch performance, deviation trends, and inspection readiness. 

• Oversee operational execution related to scheduling, manufacturing, quality, finances, supply chain, and regulatory coordination, supporting both clinical and commercial production requirements. 

• Serve as primary relationship manager and point of escalation with CDMO partners, facilitating communication, issue resolution, and alignment across technical operations, quality, supply chain, and regulatory affairs. 

• Ensure that CDMOs adhere to GMP standards, supplier control expectations, and structured oversight programs to prevent supply interruptions, deviations, or regulatory findings.  

• Ensure compliance with expectations outlined in ICH Q10 Pharmaceutical Quality System, including quality agreements, risk‑based assessments, and ongoing monitoring of contractor suitability. 

 Qualifications: 

• Deep expertise in biologics/vaccine manufacturing processes, including technical rigor needed for complex biologics, vaccines, or microbial systems used in drug substance and drug product manufacture 

• Strong understanding of GMP requirements, supplier control, and CDMO oversight, including audit readiness, risk‑based oversight frameworks, and facility qualification expectations 

• Experience managing complex GMP manufacturing programs, including scheduling, budgeting, cross‑functional coordination, and oversight of clinical and commercial production. 

• Ability to lead structured technology transfers, resolve investigations, and maintain robust process performance across multiple CDMO sites 

 Education and/or Experience: 

• Bachelor’s or advanced degree in Biology, Life Sciences, Engineering, or related scientific discipline, consistent with external CDMO‑oversight manufacturing leadership roles. 

• 8–20+ years of relevant biopharmaceutical manufacturing or CDMO management experience, depending on seniority (Director → VP), with increasing responsibility across GMP production, external manufacturing, or technical operations. 

Physical Demands:  

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

 Average travel for this position is 20% with some variations based on the demands of the business needs.

• Must be willing to travel to New York City office as needed.

Work Environment: 

 The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• No specific work demands.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Why You’ll Love Working at Protara

• Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.
• Company-wide dedication to profoundly impacting patients’ lives.
• Amazing culture whereby our core values and behaviors are shared cross-functionally.
• Flexible working hours/schedule.
• Generous Paid Holidays and Unlimited PTO.

Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws.

Company Overview:

Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.

Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source. This honor demonstrates the company’s desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation.  Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.

This role is required to be on site in Winston Salem, NC.

Job Overview: 

• Lead development of innovative analytical methods and analytical support of manufacturing operations. 

• Collaborate with Quality, Manufacturing and Regulatory functions to achieve project objectives and timelines. 

 Essential Duties and Responsibilities: 

• Lead analytical method development, qualification, and validation for in‑process, release, and stability testing to support clinical and commercial manufacturing. 

• Develop phase‑appropriate analytical control strategies, including specification setting, comparability assessments, and product characterization. 

• Provide hands‑on technical support during manufacturing campaigns, enabling analysts to execute in‑process methods and troubleshoot analytical or process‑related issues. 

• Support real‑time investigations for OOS/OOT/OOE, deviations, and adverse stability trends; contribute root‑cause analysis and corrective actions. 

• Ensure analytical readiness for GMP execution by guiding analysts on sample handling, method execution, and adherence to SOP's. 

• Partner with Process Development, Manufacturing, Quality, and Regulatory teams to ensure smooth integration of new or revised analytical methods into batch manufacturing. 

• Contribute analytical content for CMC sections of regulatory submissions (IND/IMPD/BLA/MAA), including method descriptions, validation packages, and responses to agency questions. 

 Qualifications: 

• Extensive experience in biologics analytical development, including method development, comparability, characterization, and phase‑appropriate validation. 

• Strong understanding of cGMP analytical execution, QC testing, and method lifecycle governance in a CDMO environment. 

• Ability to summarize complex analytical/technical issues clearly and provide practical guidance to support manufacturing operations. 

 Education and/or Experience: 

• Bachelor’s, Master’s, or PhD in Biochemistry, Biology, Analytical Chemistry, Biotechnology, or related Life Sciences field. 

• 8–15+ years of experience in analytical method development, QC method lifecycle management, or process‑analytical support within biologics/bioprocessing. (Director roles typically require extensive expertise.)  

• Hands‑on experience with GMP batch support, including method troubleshooting, analyst guidance, and real‑time manufacturing support. 

• Experience contributing to regulatory filings and supporting clinical → commercial analytical readiness. 

Physical Demands:  

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

 Average travel for this position is 20% with some variations based on the demands of the business needs.

• Must be willing to travel to New York City office as needed.

Work Environment: 

 The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• No specific work demands.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Why You’ll Love Working at Protara

• Friendly, open, and fun team-oriented culture that values unique & diverse perspectives.
• Company-wide dedication to profoundly impacting patients’ lives.
• Amazing culture whereby our core values and behaviors are shared cross-functionally.
• Flexible working hours/schedule.
• Generous Paid Holidays and Unlimited PTO.

Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws.

Advanced Practice Clinician (Clinical Lead) - Hepatology

At Target RWE, our mission is driven by a deep commitment to people, the patients we serve, the partners we collaborate with, and the dedicated team members who power our work. As a purpose-driven organization, we leverage real-world data to advance clinical research and inform better healthcare decisions. We foster a collaborative environment where every voice is heard, every idea has an impact, and every contribution helps improve lives. If you're seeking a place where your work truly matters, join us to help advance science securely and responsibly.

Target RWE is seeking an energetic, experienced Advanced Practice Provider (NP, PA or MD/DO) to support our expanding Hepatology therapeutic area in the real-world evidence space. This individual will bring deep expertise in managing complex liver diseases, with a specific focus on cirrhosis, leveraging the unique perspective of an APP.

The APP Clinical Lead reports to the Chief Clinical Officer and is responsible for assisting with clinical aspects of Target RWE's hepatology clinical evidence generation, ensuring scientific rigor and strategic alignment with industry partners while delivering high-quality, impactful insights within a collaborative, scientific environment.

What You’ll Do

• Hepatology Clinical Leadership: In collaboration with the Chief Clinical Officer, facilitate the development and execution of hepatology real-world evidence (RWE) and prospective studies, ensuring relevance to liver disease, methodological soundness, and alignment with industry partner needs.
• Industry Partner Collaboration: Serve as a key clinical liaison for industry partners within the hepatology space, understanding their evidence generation needs, and working within a collaborative team environment to translate them into actionable RWE projects.
• Scientific and Clinical Oversight: Provide expert clinical guidance across all phases of Target RWE hepatology projects, from protocol development to data accuracy, data analysis, interpretation, and dissemination.
• Thought Leadership: Represent Target RWE as a thought leader in hepatology clinical evidence generation, participating in scientific conferences, publishing research, to advance the field.
• Strategic Growth: Contribute to the overall strategic direction of Target RWE, identifying opportunities for growth and innovation within hepatology research.

What We Are Looking For

• Clinician, e.g. Nurse Practitioner (NP), Physician Assistant (PA), or medical doctor (MD/DO), with active credentials and certification.
• 5+ years of clinical experience managing patients with liver disease, including a strong focus on patients with cirrhosis.
• Direct clinical experience working at a medical center affiliated with a liver transplant program.
• Deep knowledge and experience with current and emerging therapies across the hepatology landscape.
• Strong communication skills with the ability to translate complex science into clear strategic insights.
• Comfort working in a fast-paced, collaborative, and entrepreneurial environment.

Preferred Qualifications

• Demonstrated experience in clinical research, real-world evidence, epidemiology, or clinical trials.
• Prior experience in biopharma, CRO, health tech, or RWE organizations.
• Record of scientific contributions (e.g., publications, trial support, advisory roles).
• Experience working with large real-world datasets (EHR, claims, registries)
• Additional clinical experience managing patients with Gastrointestinal (GI) diseases.

If you’re excited to contribute to systems that support meaningful healthcare research, where your expertise directly contributes to trust, compliance, and patient impact, Target RWE is the place for you. We’re building something important together, and we’d love for you to be a part of it.

What We Offer You

• Hybrid work — 3 days/week in our brand-new RTP office!
• Comprehensive health, dental, and vision for you and your family
• 401(k) with company match
• Generous PTO and company holidays
• Paid parental leave

NoviSci, a division of Target RWE, is a data science organization with a dual mission:

1.  Developing best-in-class software to support the generation of RWE and
2.  Executing high-impact, tech-enabled scientific consulting and research.

Overview

We are currently seeking a Senior Epidemiologist to join a team of epidemiologists, statisticians, data engineers, and software developers. Together, you will lead the design and implementation of research studies using complex, real-world data. In this role, you will apply leading-edge methodology in epidemiology and statistics to solve important problems in health care.  

What You’ll Do

• Independently design and conduct research studies using advanced epidemiologic and statistical methods, such as causal inference and machine learning
• Lead a cross-functional technical team to ensure scientific integrity and methodological rigor across all phases of the study lifecycle including initial design, protocol development, implementation of statistical analysis, and dissemination of results
• Serve as a key scientific point of contact, engaging directly with clients and external collaborators. Comfort and proficiency in client-facing roles are essential skills 
• Disseminate study findings via study reports, presentations to internal and external stakeholders, peer-reviewed publications, and abstracts and presentations at professional conferences
• Provide technical support to the business development team to develop competitive scientific proposals 

What You’ll Bring

• Advanced degree (PhD or equivalent) in epidemiology, biostatistics, or a related quantitative discipline
• 4+ years of post-doctoral experience, preferably in a biotech or scientific consulting environment
• Experience with observational research methods for causal inference (e.g., inverse probability weighting, negative control outcomes/exposures, target trial emulation, quantitative bias analyses) coupled with a genuine intellectual curiosity to dig deep and explore novel approaches to answer hard questions
• Demonstrated experience leading research projects teams from conception to publication 
• Experience with administrative claims or electronic health record data, including familiarity with using diagnosis, procedure, and medication coding algorithms to operationalize eligibility criteria, exposure status, and clinical outcomes in real-world data.
• Strong aptitude for precise and impactful scientific writing evidenced by a record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation. 
• Strong organizational and planning skills including an ability to independently troubleshoot problems and think analytically in a fast-paced environment
• Willingness to take initiative while maintaining open lines of communication with colleagues and senior leadership. 
• Excellent time management skills and ability to multi-task and prioritize work

Nice-to-Have Background

• Expertise in statistical programming using R
• Experience mentoring junior research staff

If you’re excited to help support meaningful healthcare research, where your expertise directly contributes to rigor, trust, and improved patient outcomes, NoviSci is the place for you. We’re building something important, and we’d love for you to be a part of it.

What We Offer You

• Comprehensive health, dental, and vision coverage for you and your family
• 401(k) with company match
• Generous PTO and company holidays
• Paid parental leave
• Hybrid role: Located in Research Triangle Park, North Carolina

At Target RWE, our mission is driven by a deep commitment to people, whether it’s the patients we serve, the partners we collaborate with, or the dedicated team members who power our work. As a purpose-driven organization, we leverage real-world data to advance clinical research and inform better healthcare decisions. We foster a collaborative environment where every voice is heard, every idea has an impact, and every contribution helps improve lives. If you're seeking a place where your work truly matters, join us to advance science.

Overview

In this role, you will be a foundational member of Target RWE’s Quantitative Sciences (QS) organization, helping to establish Target as a leader in rigorous, reproducible, and regulatory-grade evidence generation. You will serve as a scientific owner of Target’s data, developing deep expertise in its structure, quality, and applications while helping to build scalable data validation, curation, and analytic processes that ensure reliability and usability.

Working closely with cross-functional partners in Product, Engineering, Clinical Operations, and Medical Science, you will design and execute analyses that demonstrate the value of Target’s data, support customers across life sciences, regulatory, and academic settings, and build scalable, standardized analytic approaches for real-world evidence generation.

What You’ll Do

1. Data Ownership and Quality 

• You will establish Target’s data as a trusted, validated scientific asset.
• Ensure Target’s data are accurate, complete, and fit for regulatory and scientific use by building systems and practices that establish trust in data integrity and readiness for analysis.
• Develop deep expertise in Target’s data, understanding its structure, provenance, strengths, and limitations.
• Design and implement validation frameworks, data quality checks, and “fitness-for-use” assessments.
• Create and maintain data dictionaries and documentation that promote transparency and reproducibility.

2. Analytical excellence 

• You will apply advanced analytic methods and scientific rigor to generate reliable, reproducible, and regulatory-grade real-world evidence from Target’s data assets.
  • Support the design and execution of retrospective and prospective studies using Target’s data assets.
  • Develop statistical analysis plans and analytic code for descriptive, comparative, and predictive analyses.
  • Design and implement scalable, reusable analytic frameworks and modular code structures that support consistent execution across therapeutic areas and data products.
  • Apply best practices in methodology, version control, code review, and documentation to ensure reproducibility.
  • Translate complex results into clear visualizations and insights for scientific, regulatory, and client audiences.
  • Contribute to publications, abstracts, and collaborations that advance Target’s scientific reputation and influence.

3. Cross functional partnership

• You will work cross-functionally to connect data, science, and strategy, ensuring Target’s evidence generation aligns with customer needs and business goals.
• Partner closely with Commercial, Medical Science, Product, Data Insights, Engineering, and Clinical Operations teams to align on data strategy and analytic priorities.
• Serve as the internal “voice of the customer,” anticipating how clients, regulators, and researchers will use Target’s data.
• Participate in client and partner meetings to demonstrate the validity and value of Target’s data products.
• Leverage your deep knowledge of Target’s data assets to guide internal teams and external partners, anticipating analytical and operational challenges and helping to shape data use strategies.
• Translate analytic findings and data characteristics into clear, client-facing materials that demonstrate Target’s data quality, representativeness, and scientific utility.

What You’ll Bring

• Advanced degree (MS or PhD) in biostatistics, epidemiology, health economics, bioinformatics, data science, or a related quantitative field. 
• 5-10+ years of experience working with real-world data (e.g., EMR, claims, registry, or clinical trial data).
• Strong programming expertise in R, and experience with reproducible analytic frameworks.
• Proven expertise in data quality assessment, validation, and curation workflows.
• Demonstrated ability to build and maintain reproducible coding practices and scalable analytic processes that enable efficiency, transparency, and consistency across studies.
• Strong communication, presentation and collaboration skills with cross-functional technical and scientific teams.
• Demonstrated ability to translate data insights into actionable scientific or business recommendations.

What we offer you

• Hybrid work — 3 days/week in our brand-new office!
• Comprehensive health, dental, and vision for you and your family
• 401(k) with company match
• Generous PTO and company holidays
• Paid parental leave 

Position Summary:
The Senior Contracts Attorney will play a key role in managing and negotiating a broad range of agreements supporting all aspects of business operations. This position requires strong expertise in contract law, preferably with experience at a public life sciences company. The successful candidate will demonstrate exceptional organizational skills, the ability to manage multiple priorities, and have a proactive approach to problem-solving and stakeholder engagement.

Responsibilities:

• Draft, review, negotiate, and manage a wide variety of contracts, including but not limited to CDAs, consulting agreements, master service agreements, vendor agreements, real estate contracts, clinical trial related contracts and research collaborations.
• Serve as a subject matter expert on contract matters and processes and provide guidance to internal stakeholders.
• Collaborate with cross-functional teams (Clinical Operations, Finance, Procurement, HR, Manufacturing, Research) to ensure compliance and efficiency in contract execution.
• Develop and maintain standardized templates and processes for contract management.
• Provide training and support to business units on contract requirements and approval workflows.
• Advise stakeholders on contractual rights, obligations, and risk mitigation strategies.
• Identify and resolve issues impacting timely completion of contracts.
• Utilize e-signature platforms and ensure proper document finalization and execution.

 Qualifications:

• Juris Doctor (J.D.) from an accredited law school.
• Minimum of 5 years of experience drafting, negotiating, and managing contracts, preferably in a public life sciences company.
  • Experience in a law firm and/or in-house legal department required.
• Comprehensive understanding of contract law and working knowledge of drug development or commercialization a plus.
• Exceptional negotiation, drafting, and analytical skills.
  • Strong organizational and time-management abilities; capable of handling multiple projects under tight deadlines.
  • Excellent interpersonal and communication skills with a customer-service mindset.
  • Ability to work independently and collaboratively in a fast-paced environment.
• Admission to the bar in at least one U.S. state.