Senior Director jobs at Scholar Rock

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: Scholar Rock is seeking an experienced and motivated Director/Sr. Director of Quality Systems and GxP Compliance. Reporting to the Head of Quality, this position will oversee all aspects of quality systems and compliance for commercial, clinical, and development activities. The position is responsible for managing an effective Quality Management System to ensure continued compliance with all global regulatory requirements.Position Responsibilities: Serve as the Quality Lead for Quality Systems and Compliance operations across the company and manage quality and compliance guidance to the quality function. Oversee and manage GxP Training, Document control, and QMS GxP operations-including change controls, deviations, CAPAs, complaints, audit records, and supplier management activities. Track and manage the lifecycle of quality system records to uphold the integrity and compliance of Scholar Rock's Quality system. Ensure timely intake and triage of product complaints, accurate complaint documentation, timely escalation, and proper reconciliation with related systems and departments. Assign and manage GxP training via training system, monitor compliance, and generate training completion reports, as needed. Participate in validation efforts for new or updated GxP IT systems through review of documentation, execution of test scripts, and supporting change controls as needed. Compile and provide metrics related to Quality management system and suppliers for periodic Quality management review meetings. Implement and oversee Scholar Rock's internal audit program. Facilitate continuous improvement initiatives to transform and maintain compliance, improving QMS business process efficiency. Support inspection readiness activities, as needed. Support regulatory submissions including but not limited to annual reports, IND/CTA updates, and/or marketing authorizations. Lead and manage the Quality Systems and Compliance team, including direct reports. Collaborate with the Head of Quality and site leadership to ensure alignment with corporate goals, customer expectations, and regulatory obligations (FDA, EU, and other global regulators). Candidate Requirements: BS/MS degree in a scientific discipline 10+ years of experience in the pharmaceutical/biotech industry, with 5-7 years in leadership roles within Quality or Quality related functions. Deep understanding and current knowledge of all relevant GxP and Quality System requirements (US, EU) for pharmaceutical and biotech, manufacturing and related activities. Experience leading and managing regulatory inspections and interfacing with Global Health Authorities. Demonstrated understanding of electronic Quality Management Systems, Document Management Systems, and Learning Management Systems. Hands-on experience with systems such as Veeva Vault is preferred. Highly proactive, decisive, and capable of independently managing key initiatives. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

We are seeking a dynamic Director, Program Leadership & Management, to provide leadership, strategic direction and program management to our Development and Commercial Program Teams. In partnership with the Program Lead, the Director, Program Leadership & Management will drive development and deliver results for programs in early to late phase clinical development and/or lifecycle management programs. The successful candidate should possess and demonstrate a firm understanding of drug development, be comfortable with ambiguity, and have strong communication skills, enabling effective communication within program teams and throughout the organization. This role is highly cross-functional and will involve collaboration with internal and potentially external partners. In partnership with the Program Lead, the Director, Program Leadership & Management is charged with leading daily program management activities, including the development and execution of the program's Integrated Development Strategy. He/she/they is expected to understand the overall program strategy and critical path activities, including risks and potential mitigation plans. Key Responsibilities: * Strategic partner to the Program Lead, enabling development and ensuring execution of the Integrated Development Strategy- 50% * In partnership with the Program Lead, drives the development and execution of strategic, integrated development plans through effective leadership of Program Teams * Provides clear direction on product development requirements to meet the expectations of external customers and business stakeholders * Monitors program progress and related KPIs, identifies gaps and risks and makes strategic recommendations * Supports the execution and continuous re-assessment of development strategy in support of the overarching corporate strategy * Ensures the effective and consistent operation of high-functioning program teams - 50% * Facilitates program team mtgs to ensure productive and efficient discussion * Ensures clear and timely communication of program strategy and progress to relevant stakeholders * Orchestrates the integration of sub-teams to support the effectors of Program Teams * Other duties and responsibilities as assigned Qualifications Required Qualifications * Bachelor's or Master's with 12+ years of R&D and/or drug development project management experience * Strong organizational and communication skills * Demonstrated knowledge of the drug development process * Knowledge of project management software/tools * Ability to manage team dynamics and handle multiple projects Preferred Capabilities * Experience supporting a clinical trial * Experience in developing drugs for oncology, neurology and/or orphan diseases Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $189,000 - $259,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

We are seeking a dynamic Director, Program Leadership & Management, to provide leadership, strategic direction and program management to our Development and Commercial Program Teams. In partnership with the Program Lead, the Director, Program Leadership & Management will drive development and deliver results for programs in early to late phase clinical development and/or lifecycle management programs. The successful candidate should possess and demonstrate a firm understanding of drug development, be comfortable with ambiguity, and have strong communication skills, enabling effective communication within program teams and throughout the organization. This role is highly cross-functional and will involve collaboration with internal and potentially external partners. In partnership with the Program Lead, the Director, Program Leadership & Management is charged with leading daily program management activities, including the development and execution of the program's Integrated Development Strategy. He/she/they is expected to understand the overall program strategy and critical path activities, including risks and potential mitigation plans. Key Responsibilities: Strategic partner to the Program Lead, enabling development and ensuring execution of the Integrated Development Strategy- 50% In partnership with the Program Lead, drives the development and execution of strategic, integrated development plans through effective leadership of Program Teams Provides clear direction on product development requirements to meet the expectations of external customers and business stakeholders Monitors program progress and related KPIs, identifies gaps and risks and makes strategic recommendations Supports the execution and continuous re-assessment of development strategy in support of the overarching corporate strategy Ensures the effective and consistent operation of high-functioning program teams - 50% Facilitates program team mtgs to ensure productive and efficient discussion Ensures clear and timely communication of program strategy and progress to relevant stakeholders Orchestrates the integration of sub-teams to support the effectors of Program Teams Other duties and responsibilities as assigned Qualifications Required Qualifications Bachelor's or Master's with 12+ years of R&D and/or drug development project management experience Strong organizational and communication skills Demonstrated knowledge of the drug development process Knowledge of project management software/tools Ability to manage team dynamics and handle multiple projects Preferred Capabilities Experience supporting a clinical trial Experience in developing drugs for oncology, neurology and/or orphan diseases Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $189,000 - $259,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

We are seeking a dynamic Associate Director, Program Leadership & Management, to provide leadership, strategic direction and program management to our Development and Commercial Program Teams. In partnership with the Program Lead, the Associate Director, Program Leadership & Management will drive development and deliver results for programs in early to late phase clinical development and/or lifecycle management programs. The successful candidate should possess and demonstrate a firm understanding of drug development, be comfortable with ambiguity, and have strong communication skills, enabling effective communication within program teams and throughout the organization. This role is highly cross-functional and will involve collaboration with internal and potentially external partners. In partnership with the Program Lead, the Associate Director, Program Leadership & Management is charged with leading daily program management activities, including the development and execution of the program's Integrated Development Strategy. He/she/they is expected to have an understanding of the overall program strategy and critical path activities, including risks and potential mitigation plans. Key Responsibilities * Strategic partner to the Program Lead (50%) * In partnership with the Program Lead, drive the development and execution of strategic, integrated development plans through effective leadership of Program Teams * Provides clear direction on product development requirements to meet the expectations of external customers and business stakeholders * Monitors program progress and related KPIs, identifies gaps and risks and makes strategic recommendations * Supports the execution and continuous re-assessment of development strategy in support of the overarching corporate strategy * Drive operational excellence across program teams (50%) * Facilitates program team meetings to ensure productive and efficient discussion * Ensures clear and timely communication of program strategy and progress to relevant stakeholders * Orchestrates the integration of sub-teams to support the effectors of Program Teams Qualifications Required Qualifications * Bachelors or Masters with 10+ years of experience of R&D and/or drug development project management experience * Strong organizational and communication skills * Demonstrated knowledge of the drug development process * Knowledge of project management software/tools * Ability to manage team dynamics and handle multiple projects Preferred Experience * Experience supporting a clinical trial * Experience in developing drugs for oncology, neurology and/or orphan diseases Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $163,000 - $225,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: * Competitive salary and annual bonus. * Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. * Generous parental leave and family planning benefits. * Outstanding culture and opportunities for personal and professional growth. Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team! EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

Job Description We are seeking a dynamic Associate Director, Program Leadership & Management, to provide leadership, strategic direction and program management to our Development and Commercial Program Teams. In partnership with the Program Lead, the Associate Director, Program Leadership & Management will drive development and deliver results for programs in early to late phase clinical development and/or lifecycle management programs. The successful candidate should possess and demonstrate a firm understanding of drug development, be comfortable with ambiguity, and have strong communication skills, enabling effective communication within program teams and throughout the organization. This role is highly cross-functional and will involve collaboration with internal and potentially external partners. In partnership with the Program Lead, the Associate Director, Program Leadership & Management is charged with leading daily program management activities, including the development and execution of the program's Integrated Development Strategy. He/she/they is expected to have an understanding of the overall program strategy and critical path activities, including risks and potential mitigation plans. Key Responsibilities Strategic partner to the Program Lead (50%) In partnership with the Program Lead, drive the development and execution of strategic, integrated development plans through effective leadership of Program Teams Provides clear direction on product development requirements to meet the expectations of external customers and business stakeholders Monitors program progress and related KPIs, identifies gaps and risks and makes strategic recommendations Supports the execution and continuous re-assessment of development strategy in support of the overarching corporate strategy Drive operational excellence across program teams (50%) Facilitates program team meetings to ensure productive and efficient discussion Ensures clear and timely communication of program strategy and progress to relevant stakeholders Orchestrates the integration of sub-teams to support the effectors of Program Teams Qualifications Required Qualifications Bachelors or Masters with 10+ years of experience of R&D and/or drug development project management experience Strong organizational and communication skills Demonstrated knowledge of the drug development process Knowledge of project management software/tools Ability to manage team dynamics and handle multiple projects Preferred Experience Experience supporting a clinical trial Experience in developing drugs for oncology, neurology and/or orphan diseases Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $163,000 - $225,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: Competitive salary and annual bonus. Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. Generous parental leave and family planning benefits. Outstanding culture and opportunities for personal and professional growth. Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team! EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

We are seeking a dynamic Associate Director, Program Leadership & Management , to provide leadership, strategic direction and program management to our Development and Commercial Program Teams. In partnership with the Program Lead, the Associate Director, Program Leadership & Management will drive development and deliver results for programs in early to late phase clinical development and/or lifecycle management programs. The successful candidate should possess and demonstrate a firm understanding of drug development, be comfortable with ambiguity, and have strong communication skills, enabling effective communication within program teams and throughout the organization. This role is highly cross-functional and will involve collaboration with internal and potentially external partners. In partnership with the Program Lead, the Associate Director, Program Leadership & Management is charged with leading daily program management activities, including the development and execution of the program's Integrated Development Strategy. He/she/they is expected to have an understanding of the overall program strategy and critical path activities, including risks and potential mitigation plans. Key Responsibilities Strategic partner to the Program Lead (50%) In partnership with the Program Lead, drive the development and execution of strategic, integrated development plans through effective leadership of Program Teams Provides clear direction on product development requirements to meet the expectations of external customers and business stakeholders Monitors program progress and related KPIs, identifies gaps and risks and makes strategic recommendations Supports the execution and continuous re-assessment of development strategy in support of the overarching corporate strategy Drive operational excellence across program teams (50%) Facilitates program team meetings to ensure productive and efficient discussion Ensures clear and timely communication of program strategy and progress to relevant stakeholders Orchestrates the integration of sub-teams to support the effectors of Program Teams Qualifications Required Qualifications Bachelors or Masters with 10+ years of experience of R&D and/or drug development project management experience Strong organizational and communication skills Demonstrated knowledge of the drug development process Knowledge of project management software/tools Ability to manage team dynamics and handle multiple projects Preferred Experience Experience supporting a clinical trial Experience in developing drugs for oncology, neurology and/or orphan diseases Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $163,000 - $225,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: Competitive salary and annual bonus. Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. Generous parental leave and family planning benefits. Outstanding culture and opportunities for personal and professional growth. Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team! EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

The Senior Director, Pharmacovigilance Sciences Lead plays a critical role by leading the PV Sciences team and providing strategic oversight for safety data analyses for investigational and marketed products across the portfolio. The Senior Director, Pharmacovigilance Sciences Lead is expected to be equally effective in working collaboratively and independently. She/he will be responsible for overseeing the team of PV Scientists that conduct activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA, etc.), and contributions to key documents (IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable). The Senior Director, Pharmacovigilance Sciences Lead will also be accountable for relevant process improvement initiatives, strategic innovations, and team leadership. Key Responsibilities: * Oversees PV Sciences deliverables across the portfolio - 50% * Ensures that PV Sciences activities are conducted in accordance with relevant processes and regulations, including: * Signal detection, evaluation, and management * Aggregate safety reports (DSURs, PADERs, PBRERs) * Risk management plans (including maintenance and implementation of risk minimization measures) * Literature surveillance * Safety governance meeting preparation and documentation * Safety-related regulatory query responses * Safety-related contributions to key documents (IB/RSIs, CCDS/labels, ICF, etc.) * Contributions to safety analyses associated with regulatory filings (e.g., New Drug Applications or Marketing Authorisation Applications) * Inspection preparation and execution * Strategic leadership, management, and mentorship - 50% * Sets strategy for the PV Sciences team, aligning with corporate goals and safety objectives, and ensures that relevant goals are met * Leads recruitment, mentoring, career development, and performance management of PV Sciences team * Collaborate with cross-functional teams such as Clinical Development, Regulatory Affairs, Quality, Medical Affairs and other relevant functions to maintain integrated safety oversight. * Leads process improvements and conducts impact assessments * Ensures appropriate training and individual development for direct and indirect reports * Other duties and responsibilities as assigned Qualifications Required Qualifications: * PhD or equivalent plus 10+ years of experience or Bachelors or Masters plus 15+ years of experience in a PV scientist role. * Demonstrated experience in analysis and interpretation of medical and scientific data, including experience in both post-marketing and clinical trials * Excellent oral and written communication skills, including the ability to effectively communicate with senior leadership * Detail-oriented with ability to think critically, prioritize tasks, and function independently * Expert knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations * Proven track record in preparing and reviewing regulatory safety documents, including NDAs/MAAs and RMPs * Prior experience serving as an SME in audits and/or inspections Preferred Capabilities: * Demonstrated experience in the oncology therapeutic area * Expert proficiency with pharmacovigilance databases and relevant coding dictionaries * Expert knowledge/proficiency with Microsoft Office Suite and Argus Safety systems. Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $247,000 - $340,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: * Competitive salary and annual bonus. * Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. * Generous parental leave and family planning benefits. * Outstanding culture and opportunities for personal and professional growth. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

The Senior Director, Pharmacovigilance Sciences Lead plays a critical role by leading the PV Sciences team and providing strategic oversight for safety data analyses for investigational and marketed products across the portfolio. The Senior Director, Pharmacovigilance Sciences Lead is expected to be equally effective in working collaboratively and independently. She/he will be responsible for overseeing the team of PV Scientists that conduct activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA, etc.), and contributions to key documents (IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable). The Senior Director, Pharmacovigilance Sciences Lead will also be accountable for relevant process improvement initiatives, strategic innovations, and team leadership. Key Responsibilities: Oversees PV Sciences deliverables across the portfolio - 50% Ensures that PV Sciences activities are conducted in accordance with relevant processes and regulations, including: Signal detection, evaluation, and management Aggregate safety reports (DSURs, PADERs, PBRERs) Risk management plans (including maintenance and implementation of risk minimization measures) Literature surveillance Safety governance meeting preparation and documentation Safety-related regulatory query responses Safety-related contributions to key documents (IB/RSIs, CCDS/labels, ICF, etc.) Contributions to safety analyses associated with regulatory filings (e.g., New Drug Applications or Marketing Authorisation Applications) Inspection preparation and execution Strategic leadership, management, and mentorship - 50% Sets strategy for the PV Sciences team, aligning with corporate goals and safety objectives, and ensures that relevant goals are met Leads recruitment, mentoring, career development, and performance management of PV Sciences team Collaborate with cross-functional teams such as Clinical Development, Regulatory Affairs, Quality, Medical Affairs and other relevant functions to maintain integrated safety oversight. Leads process improvements and conducts impact assessments Ensures appropriate training and individual development for direct and indirect reports Other duties and responsibilities as assigned Qualifications Required Qualifications: PhD or equivalent plus 10+ years of experience or Bachelors or Masters plus 15+ years of experience in a PV scientist role. Demonstrated experience in analysis and interpretation of medical and scientific data, including experience in both post-marketing and clinical trials Excellent oral and written communication skills, including the ability to effectively communicate with senior leadership Detail-oriented with ability to think critically, prioritize tasks, and function independently Expert knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations Proven track record in preparing and reviewing regulatory safety documents, including NDAs/MAAs and RMPs Prior experience serving as an SME in audits and/or inspections Preferred Capabilities: Demonstrated experience in the oncology therapeutic area Expert proficiency with pharmacovigilance databases and relevant coding dictionaries Expert knowledge/proficiency with Microsoft Office Suite and Argus Safety systems. Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $247,000 - $340,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: Competitive salary and annual bonus. Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. Generous parental leave and family planning benefits. Outstanding culture and opportunities for personal and professional growth. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

The Senior Director, Pharmacovigilance Sciences Lead plays a critical role by leading the PV Sciences team and providing strategic oversight for safety data analyses for investigational and marketed products across the portfolio. The Senior Director, Pharmacovigilance Sciences Lead is expected to be equally effective in working collaboratively and independently. She/he will be responsible for overseeing the team of PV Scientists that conduct activities such as signal management, aggregate reports, RMP development, ad hoc safety query responses, literature surveillance, and safety analyses for regulatory submissions (NDA, MAA, etc.), and contributions to key documents (IB/RSIs, ICFs, SMPs, DMC materials, coding reviews, and safety analyses for CSRs, as applicable). The Senior Director, Pharmacovigilance Sciences Lead will also be accountable for relevant process improvement initiatives, strategic innovations, and team leadership. Key Responsibilities: Oversees PV Sciences deliverables across the portfolio - 50% Ensures that PV Sciences activities are conducted in accordance with relevant processes and regulations, including: Signal detection, evaluation, and management Aggregate safety reports (DSURs, PADERs, PBRERs) Risk management plans (including maintenance and implementation of risk minimization measures) Literature surveillance Safety governance meeting preparation and documentation Safety-related regulatory query responses Safety-related contributions to key documents (IB/RSIs, CCDS/labels, ICF, etc.) Contributions to safety analyses associated with regulatory filings (e.g., New Drug Applications or Marketing Authorisation Applications) Inspection preparation and execution Strategic leadership, management, and mentorship - 50% Sets strategy for the PV Sciences team, aligning with corporate goals and safety objectives, and ensures that relevant goals are met Leads recruitment, mentoring, career development, and performance management of PV Sciences team Collaborate with cross-functional teams such as Clinical Development, Regulatory Affairs, Quality, Medical Affairs and other relevant functions to maintain integrated safety oversight. Leads process improvements and conducts impact assessments Ensures appropriate training and individual development for direct and indirect reports Other duties and responsibilities as assigned Qualifications Required Qualifications: PhD or equivalent plus 10+ years of experience or Bachelors or Masters plus 15+ years of experience in a PV scientist role. Demonstrated experience in analysis and interpretation of medical and scientific data, including experience in both post-marketing and clinical trials Excellent oral and written communication skills, including the ability to effectively communicate with senior leadership Detail-oriented with ability to think critically, prioritize tasks, and function independently Expert knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations Proven track record in preparing and reviewing regulatory safety documents, including NDAs/MAAs and RMPs Prior experience serving as an SME in audits and/or inspections Preferred Capabilities: Demonstrated experience in the oncology therapeutic area Expert proficiency with pharmacovigilance databases and relevant coding dictionaries Expert knowledge/proficiency with Microsoft Office Suite and Argus Safety systems. Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $247,000 - $340,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: Competitive salary and annual bonus. Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. Generous parental leave and family planning benefits. Outstanding culture and opportunities for personal and professional growth. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

We are seeking a Senior Director, Legal Counsel to serve as a senior leader providing strategic advice in drafting, negotiating, and interpreting general and sophisticated corporate agreements across all functions, including Research & Discovery, Commercial, Licensing and Distribution, Supply Chain, Tech Ops, Clinical, IT and Facilities. The primary responsibilities of the Senior Director, Legal Counsel will be overseeing the Contracts Team and outside counsel and supporting the General Counsel in a variety of high-impact strategic legal projects and initiatives. We are seeking a dynamic and collaborative life sciences attorney who wants to contribute to the growth of a thriving, fast-paced global organization. This role also includes collaboration with our European colleagues and Japanese parent company, requiring strong cross-cultural communication skills and the ability to manage strategic initiatives spanning multiple countries and affiliates. Key Responsibilities: Contracting Oversight and Negotiation (50%) Develop, mentor, and motivate highly-skilled Contracts Team, and support career paths of team members Serve as key legal advisor to business teams, including overseeing negotiation of routine and sophisticated contracts, in the context of cross functional and geographically and culturally diverse teams Serve as lead negotiator on a range of critical and complex agreements Drive Contracting Best Practices (20%) Build, maintain, and enhance efficient contracts operations and infrastructure and drive continuous improvement Cultivate collaborative partnerships with stakeholders and Contracts Team to effectively communicate challenges and opportunities and deliver solutions Legal Strategy and Leadership (30%) Provide legal support across the organization on a variety of matters, including legal aspects of development strategy, regulatory activities, and HR processes, and quickly and effectively identify complex legal and compliance issues and provide advice that integrates legal risk management with the company's business objectives Proactively manage cross-border communication on legal operations and strategic projects, and cultivate collaborative relationships with Japanese counterparts Maintain a positive team culture grounded in Deciphera's core values of PATHS Manage and complete any additional projects or legal matters as needed Other duties and responsibilities as assigned Qualifications Required Qualifications JD plus 10+ years of experience. Ability to manage, coach and mentor high-functioning team members Significant experience drafting and negotiation sophisticated life sciences contracts Strong understanding of the drug development and commercialization lifecycle License to practice Law in Massachusetts Excellent interpersonal and client relations skills Ability to work in a fast-paced environment leveraging internal and external resources to meet simultaneous deadlines/demands Willingness to pitch-in and help on legal projects across the organization Excellent research, writing, counselling and communication skills and a positive client service orientation Ability to work independently, as a team member, and across the organization Accountability, sound judgment, and the ability to take ownership of an issue and provide concise and timely advice Preferred Capabilities Experience being part of an international company a plus Significant experience with global clinical trials and sophisticated technical operations Prior experience participating on cross-functional cross-border program teams Prior experience advising on non-contract matters such as HR or FDA regulatory issues Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $224,200 - $308,330. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: Competitive salary and annual bonus. Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. Generous parental leave and family planning benefits. Outstanding culture and opportunities for personal and professional growth. Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team! EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

Job Description Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: We are searching for a Senior Director of Commercial Training to help support, grow and foster Scholar Rock's team of patient centric, collaborative and excellence driven professionals. You will lead the creation and effective implementation of curriculums for disease and product education, enhancing engagement competencies to ensure effective business execution that drives results while enabling employees to grow and thrive. You will partner across the Commercial team and work directly with leaders and individual contributors to set up the short and long-term vision for Commercial Training. The successful candidate will effectively partner with relevant departments, including field and Commercial leadership, marketing, market access, commercial operations, medical affairs, legal, and HR. This individual should inspire a dynamic culture and lead by example, respecting and living out the Scholar Rock values. Position Responsibilities: Build a comprehensive Global and US training strategy aligned with business objectives to enhance knowledge and skills on SMA and apitegromab across U.S. and global markets.'. Lead and oversee commercial training initiatives. Experience leading "development" initiatives, i.e., training, coaching, learning initiatives Define and implement optimal learning strategies-including live/virtual instructor-led sessions, e-learning, blended, and social learning-leveraging best practices in instructional design. Own all curriculum components requiring promotional review and legal/regulatory/compliance approval, ensuring accuracy and adherence to standards. Lead creation and standardization of Launch Excellence frameworks from early planning through post-launch sustainment. Design and train on learning solutions grounded in adult learning theory to maximize knowledge of retention and application. Oversee development and facilitation of dynamic workshops on disease states, products, market landscapes, and contextual selling skills for diverse audiences.Train and coach leaders for key conversations that drive team performance, enabling high confidence in the performance of team members Coach leaders to ensure that employees receive balanced and actionable feedback Partner with executive leaders to provide the strategic guidance aligning people programs to business outcomes and ensuring high employee engagement Lead, evaluation and monitor training programs to ensure success and follow up to ensure training objectives are met Ensure the appropriate utilization of resources by overseeing the identification and selection of vendors as well as existing relationships and projects relating to training Lead end-to-end training efforts that deliver the measurable results aligned with project goals Design and implement practices that enable continuous improvement of a high-performance culture Other duties as assigned Candidate Requirements: Bachelor's degree in business, science or related field. A master's degree (MBA) is strongly preferred. 10+ years of experience working in the pharmaceutical or biotech industry with 8+ years of experience in sales/commercial training. Ability to lead all commercial trainings Experience leading "development" initiatives, i.e., training, coaching, learning initiatives Firm understanding and applicability of adult learning theory framework Strong interpersonal skills with demonstrated ability to drive toward consensus Exceptional, persuasive, written, and verbal communication skills. Willingness to present the facts and put forth hypothesis in the face of differing opinions Excellent presentation skills with the ability to establish logical flow and story and skilled in choosing the best graphic representation for points to be made. Experienced presenting to senior management Ability to adjust to changing needs within the organization and flexibility to change priorities as needed Ability to self-direct projects and work with little supervision. Demonstrated values-based skills and strong work ethic Pharmaceutical launch experience with an emphasis of building infrastructure and processes that do not currently exist Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: We are seeking an experienced and strategic Senior Director of CMC Process Development to lead our biologics process development function across early-stage, late-stage, and commercial programs. This role will drive the design, scale-up, and technology transfer of drug substance processes-both internally and through a global network of CDMOs. Expertise with drug substance process development for high-concentration biologics is essential.The ideal candidate combines deep technical knowledge, strong organizational leadership, and proven experience managing external collaborations and in-house teams. This role is critical to ensuring robust, scalable, processes that support clinical and commercial success. Key Responsibilities: Strategic & Functional Leadership Lead the CMC process development strategy for biologics (mAbs, fusion proteins, or similar), including upstream and downstream development. Serve as the enterprise thought leader for biologics manufacturing platforms, innovation, and process robustness. Partner with stakeholders across R&D, Regulatory, Manufacturing, and Quality to ensure alignment from development to commercial readiness. Technical Program Oversight Design and oversee process development programs across all stages (early/IND-enabling through BLA/commercial lifecycle). Guide scale-up, technology transfer, and validation activities across external manufacturing sites. Enable robust process ownership and technical oversight for clinical and commercial manufacturing. External CDMO Management Manage and oversee relationships with CDMOs for drug substance development, ensuring scientific rigor, quality, and timelines. Serve as the technical lead for external development and manufacturing partnerships, including CDMO selection and oversight of SOWs, budgets, and technical deliverables. Organizational Development Build and lead a high-performing CMC process development team, including technical experts and project leaders. Foster a culture of scientific excellence, cross-functional collaboration, and accountability. Regulatory Support Author and/or review CMC sections of regulatory submissions (IND, IMPD, BLA/MAA), including process descriptions, validation strategies, and control strategies. Support regulatory agency interactions, inspections, and responses to information requests. Qualifications: Required: Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field. 12+ years of relevant experience in biopharmaceutical process development, with at least 5 years in a leadership role. Proven experience developing biologics processes from early-stage through commercial launch, including PPQ and lifecycle management. Demonstrated expertise in drug substance process development of high-concentration biologics to mitigate drug product development challenges. Strong background in tech transfer, scale-up, and working with external CDMOs. Experience with process ownership and technical oversight for clinical and commercial manufacturing. Experience supporting global regulatory submissions (e.g., FDA, EMA). Preferred: Experience in a lean, entrepreneurial biotech environment. Familiarity with integrated CMC program leadership or technical operations governance frameworks Competencies: Strategic and enterprise mindset Deep technical expertise with strong decision-making capability Effective communicator with cross-functional and external partners Proactive, solution-oriented leadership style High standards of scientific rigor and compliance Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: We are searching for a Senior Director of Commercial Training to help support, grow and foster Scholar Rock's team of patient centric, collaborative and excellence driven professionals. You will lead the creation and effective implementation of curriculums for disease and product education, enhancing engagement competencies to ensure effective business execution that drives results while enabling employees to grow and thrive. You will partner across the Commercial team and work directly with leaders and individual contributors to set up the short and long-term vision for Commercial Training. The successful candidate will effectively partner with relevant departments, including field and Commercial leadership, marketing, market access, commercial operations, medical affairs, legal, and HR. This individual should inspire a dynamic culture and lead by example, respecting and living out the Scholar Rock values. Position Responsibilities: Build a comprehensive Global and US training strategy aligned with business objectives to enhance knowledge and skills on SMA and apitegromab across U.S. and global markets.'. Lead and oversee commercial training initiatives. Experience leading "development" initiatives, i.e., training, coaching, learning initiatives Define and implement optimal learning strategies-including live/virtual instructor-led sessions, e-learning, blended, and social learning-leveraging best practices in instructional design. Own all curriculum components requiring promotional review and legal/regulatory/compliance approval, ensuring accuracy and adherence to standards. Lead creation and standardization of Launch Excellence frameworks from early planning through post-launch sustainment. Design and train on learning solutions grounded in adult learning theory to maximize knowledge of retention and application. Oversee development and facilitation of dynamic workshops on disease states, products, market landscapes, and contextual selling skills for diverse audiences.Train and coach leaders for key conversations that drive team performance, enabling high confidence in the performance of team members Coach leaders to ensure that employees receive balanced and actionable feedback Partner with executive leaders to provide the strategic guidance aligning people programs to business outcomes and ensuring high employee engagement Lead, evaluation and monitor training programs to ensure success and follow up to ensure training objectives are met Ensure the appropriate utilization of resources by overseeing the identification and selection of vendors as well as existing relationships and projects relating to training Lead end-to-end training efforts that deliver the measurable results aligned with project goals Design and implement practices that enable continuous improvement of a high-performance culture Other duties as assigned Candidate Requirements: Bachelor's degree in business, science or related field. A master's degree (MBA) is strongly preferred. 10+ years of experience working in the pharmaceutical or biotech industry with 8+ years of experience in sales/commercial training. Ability to lead all commercial trainings Experience leading "development" initiatives, i.e., training, coaching, learning initiatives Firm understanding and applicability of adult learning theory framework Strong interpersonal skills with demonstrated ability to drive toward consensus Exceptional, persuasive, written, and verbal communication skills. Willingness to present the facts and put forth hypothesis in the face of differing opinions Excellent presentation skills with the ability to establish logical flow and story and skilled in choosing the best graphic representation for points to be made. Experienced presenting to senior management Ability to adjust to changing needs within the organization and flexibility to change priorities as needed Ability to self-direct projects and work with little supervision. Demonstrated values-based skills and strong work ethic Pharmaceutical launch experience with an emphasis of building infrastructure and processes that do not currently exist Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Job Description Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: Scholar Rock is seeking a highly experienced and technically strong Senior Director of Drug Product Development to lead formulation and drug product development efforts across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. This role will be responsible for driving drug product strategy and execution across modalities and presentations-from intravenous (IV) to subcutaneous (SubQ), including high-concentration formulations, prefilled syringes (PFS), and autoinjectors (AI). The ideal candidate brings extensive experience in setting strategic direction and hands-on leadership of formulation development, process development, tech transfer, and commercial readiness for biologic combination products. This position requires a deep understanding of technical and regulatory aspects of combination product development, including drug product formulation and fill/finish process, primary container development, stability.Position Responsibilities: Lead end-to-end drug product development for Scholar Rock's biologic assets across all phases-from preclinical development through commercialization. Define and execute robust formulation strategies to support both IV and SubQ presentations, including development of high-concentration (≥200 mg/mL), stable formulations. Lead the development and optimization of vial and of the target combination product presentation (pre-filled syringe / autoinjector). Collaborate with internal and external resources to achieve a combination product presentation suitable for patient use. Provide scientific leadership in evaluating excipients, container closure compatibility, viscosity, and stability to support target product profiles and patient-centric delivery. Drive selection and integration of drug delivery devices (e.g., PFS/AI) in collaboration with commercial, clinical, and regulatory functions. Establish phase-appropriate formulation control strategies and support setting and justification of specifications in coordination with Analytical Development. Direct process development activities including fill-finish process design, container closure system evaluation, and scale-up for clinical and commercial manufacturing. Lead technical due diligence, selection, and oversight of CDMOs and technical support for drug product manufacturing. Ensure successful tech transfers, manufacturing readiness, and PPQ strategy development in collaboration with Manufacturing and Quality. Apply Quality by Design (QbD) principles to develop and optimize robust drug product formulations and processes. Partner closely with Analytical Development to define and maintain specifications and support real-time release strategies. Act as the technical lead for DP-related CMC sections of regulatory submissions (INDs, BLAs, IMPDs), including response to health authority questions and engage with regulatory agencies (FDA, EMA, PMDA) to support development, inspection readiness and support. Represent Drug Product function on cross-functional CMC and program teams. Foster a culture of scientific rigor, innovation, collaboration, and continuous improvement. Candidate Requirements: Ph.D. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, or related field with 12+ years (or M.S. with 15+ years) of experience in biologics drug product development with emphasis on high concentration biologic formulation for combination product development, particularly with pre-filled syringes and autoinjectors. Deep expertise in formulation development for monoclonal antibodies and other complex biologics, including high-concentration SubQ products. Proven track record in advancing injectable drug products from early development through commercialization including demonstrated success in managing late-stage process validation studies. Experience leading workstreams for PFS/AI combination products, including primary container evaluation, combination product platform technology evaluation, design control process, design verification studies and validation, human factors engineering, and regulatory expectations. Strong technical leadership, project management, and cross-functional collaboration skills. Familiarity with regulatory expectations for DP development and CMC submissions in US and EU. Preferred Experience: Experience with combination products, device development, and cold-chain distribution. Prior leadership of external CDMO partnerships. Experience with QbD-based development and global CMC strategy implementation. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: Scholar Rock is seeking a highly experienced and technically strong Senior Director of Drug Product Development to lead formulation and drug product development efforts across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. This role will be responsible for driving drug product strategy and execution across modalities and presentations-from intravenous (IV) to subcutaneous (SubQ), including high-concentration formulations, prefilled syringes (PFS), and autoinjectors (AI). The ideal candidate brings extensive experience in setting strategic direction and hands-on leadership of formulation development, process development, tech transfer, and commercial readiness for biologic combination products. This position requires a deep understanding of technical and regulatory aspects of combination product development, including drug product formulation and fill/finish process, primary container development, stability.Position Responsibilities: Lead end-to-end drug product development for Scholar Rock's biologic assets across all phases-from preclinical development through commercialization. Define and execute robust formulation strategies to support both IV and SubQ presentations, including development of high-concentration (≥200 mg/mL), stable formulations. Lead the development and optimization of vial and of the target combination product presentation (pre-filled syringe / autoinjector). Collaborate with internal and external resources to achieve a combination product presentation suitable for patient use. Provide scientific leadership in evaluating excipients, container closure compatibility, viscosity, and stability to support target product profiles and patient-centric delivery. Drive selection and integration of drug delivery devices (e.g., PFS/AI) in collaboration with commercial, clinical, and regulatory functions. Establish phase-appropriate formulation control strategies and support setting and justification of specifications in coordination with Analytical Development. Direct process development activities including fill-finish process design, container closure system evaluation, and scale-up for clinical and commercial manufacturing. Lead technical due diligence, selection, and oversight of CDMOs and technical support for drug product manufacturing. Ensure successful tech transfers, manufacturing readiness, and PPQ strategy development in collaboration with Manufacturing and Quality. Apply Quality by Design (QbD) principles to develop and optimize robust drug product formulations and processes. Partner closely with Analytical Development to define and maintain specifications and support real-time release strategies. Act as the technical lead for DP-related CMC sections of regulatory submissions (INDs, BLAs, IMPDs), including response to health authority questions and engage with regulatory agencies (FDA, EMA, PMDA) to support development, inspection readiness and support. Represent Drug Product function on cross-functional CMC and program teams. Foster a culture of scientific rigor, innovation, collaboration, and continuous improvement. Candidate Requirements: Ph.D. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, or related field with 12+ years (or M.S. with 15+ years) of experience in biologics drug product development with emphasis on high concentration biologic formulation for combination product development, particularly with pre-filled syringes and autoinjectors. Deep expertise in formulation development for monoclonal antibodies and other complex biologics, including high-concentration SubQ products. Proven track record in advancing injectable drug products from early development through commercialization including demonstrated success in managing late-stage process validation studies. Experience leading workstreams for PFS/AI combination products, including primary container evaluation, combination product platform technology evaluation, design control process, design verification studies and validation, human factors engineering, and regulatory expectations. Strong technical leadership, project management, and cross-functional collaboration skills. Familiarity with regulatory expectations for DP development and CMC submissions in US and EU. Preferred Experience: Experience with combination products, device development, and cold-chain distribution. Prior leadership of external CDMO partnerships. Experience with QbD-based development and global CMC strategy implementation. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Job Description Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: Scholar Rock is seeking a highly experienced and organized leader to provide global CMC leadership across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. As the Director, CMC Management, you will be accountable for CMC project and portfolio management activities for our products working closely with CMC technical leads and cross-functional CMC teams. This role will require attention to detail, proficiency in forward planning and organizational skills and effective stakeholder management to ensure seamless development of CMC plans for clinical and commercial programs.Position Responsibilities: Provide leadership to develop and maintain integrated CMC development plans across our candidate programs and pro-actively identify critical path activities for key program milestones to allow for a focused and successful CMC workflow for all programs Collaborate cross-functionally to effectively monitor progress and drive CMC activities and ensure alignment with overall program goals and timelines Track program risks, proactively identifying and resolving issues, and working cross-functionally to develop contingency plans to ensure program success Support development and refinement of processes, tools, and systems to deliver high quality project management for the CMC programs Develop and maintain dashboards and organize and maintain documentation for CMC plans for each program Support Regulatory CMC with submission timelines e.g. reviews, approvals within CMC functional areas Champion a winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration Develop global CMC strategy in collaboration with CMC leads and functional teams; Proactively identify issues and drive resolution; anticipating key future events and adjusting team priorities/plans accordingly to deliver high quality results on time. Candidate Requirements: Bachelor's Degree in Science or related field, or equivalent with 12 years of related work experience, or advanced degree and a minimum of 8 years of work experience 8+ years of experience with biologics CMC early-stage, late-stage, and lifecycle management projects Experience in achieving CMC objectives through an outsourced CDMO model Excellent communication and interpersonal skills with the ability to influence and gain consensus across multiple functions, manage a diverse set of stakeholders, and work closely with team leaders Strong analytical, problem solving and critical thinking skills; highly organized. Proven track record of successful project management of complex drug development programs in a fast-paced environment Project and portfolio management certificate or expertise; expertise with project management tools (e.g. Smartsheet, MS Project, dashboards) Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast-paced environment Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: Scholar Rock is seeking a highly experienced and organized leader to provide global CMC leadership across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. As the Director, CMC Management, you will be accountable for CMC project and portfolio management activities for our products working closely with CMC technical leads and cross-functional CMC teams. This role will require attention to detail, proficiency in forward planning and organizational skills and effective stakeholder management to ensure seamless development of CMC plans for clinical and commercial programs.Position Responsibilities: Provide leadership to develop and maintain integrated CMC development plans across our candidate programs and pro-actively identify critical path activities for key program milestones to allow for a focused and successful CMC workflow for all programs Collaborate cross-functionally to effectively monitor progress and drive CMC activities and ensure alignment with overall program goals and timelines Track program risks, proactively identifying and resolving issues, and working cross-functionally to develop contingency plans to ensure program success Support development and refinement of processes, tools, and systems to deliver high quality project management for the CMC programs Develop and maintain dashboards and organize and maintain documentation for CMC plans for each program Support Regulatory CMC with submission timelines e.g. reviews, approvals within CMC functional areas Champion a winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration Develop global CMC strategy in collaboration with CMC leads and functional teams; Proactively identify issues and drive resolution; anticipating key future events and adjusting team priorities/plans accordingly to deliver high quality results on time. Candidate Requirements: Bachelor's Degree in Science or related field, or equivalent with 12 years of related work experience, or advanced degree and a minimum of 8 years of work experience 8+ years of experience with biologics CMC early-stage, late-stage, and lifecycle management projects Experience in achieving CMC objectives through an outsourced CDMO model Excellent communication and interpersonal skills with the ability to influence and gain consensus across multiple functions, manage a diverse set of stakeholders, and work closely with team leaders Strong analytical, problem solving and critical thinking skills; highly organized. Proven track record of successful project management of complex drug development programs in a fast-paced environment Project and portfolio management certificate or expertise; expertise with project management tools (e.g. Smartsheet, MS Project, dashboards) Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast-paced environment Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Job Description Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: In this role, you will be responsible for a wide variety of projects across the Commercial organization to include, but not limited to, functioning as the business lead for sales sizing and alignment, field incentive compensation design and implementation, field analytics and reporting, implementation of commercial systems, collaboration with brand marketing/e-marketing initiatives and supporting KPIs for overall performance. Additionally, you will identify critical business issues and opportunities for growth, collaborate with cross-functional teams, and work to embed an external market point-of-view into the strategic direction of the company.Position Responsibilities: Strategic Leadership & Operational Excellence Define and implement a structured framework of goals and tactics to build a best-in-class Field and Sales Operations organization. Establish and maintain robust analytics and operational processes that effectively support the General Managers and Sales organization. Data Governance & Systems Integration Serve on a cross-functional data governance team to define business rules and processes that ensure data integrity and consistency. Partner with Sales and IT to design, deploy and maintain Veeva both in the US and ROW Provide Field Operation Support for ROW Ensure organizational compliance with CRM data standards and quality protocols. Sales Enablement & Field Optimization Train the commercial field sales team on systems, tools, and processes to maximize efficiency and adoption. Develop and refine field sizing and deployment strategies to optimize sales force effectiveness and meet business objectives. Manage territory alignment and roster systems to ensure optimal resource utilization. Manages the field sales force credentialling program Performance Management & Incentives Lead the development and execution of incentive compensation programs aligned with strategic goals, including plan design, governance, goal setting, reporting, and payout processing. Monitor departmental performance against KPIs and collaborate with commercial leadership to drive continuous improvement. Cross-Functional Collaboration & Commercial Readiness Oversee and execute a broad range of commercial initiatives to ensure organizational readiness for product launches. Collaborate across the Commercial team to align operational strategies with key business objectives and priorities. Candidate Requirements: Bachelor's degree in business, science or related field. A master's degree (MBA) strongly preferred. 8-10 years of experience working in the pharmaceutical or biotech industry with five plus years supporting field sales teams. Extensive experience supporting technical design of commercial systems. Implementation experience a must. Extensive experience with Veeva CRM, data management and incentive compensation Experience with Symphony, IQVIA. CROSSIX and related pharmaceutical sales data Experience working with field sales teams, field reporting and incentive compensation Strong analytical skills with the capability to appropriately define issues, questions and data; to comprehend quantitative methods and analytical techniques; to perform accurate analysis (correctly calculated numbers, accurate graphs); to cross-check data and assumptions; to document and establish data trails; and to think creatively about different ways to analyze data and information Excellent quantitative background that supports the analysis of data to better understand market dynamics and provide insights into product performance and marketing strategy. Strong interpersonal skills with demonstrated ability to drive toward consensus. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: In this role, you will be responsible for a wide variety of projects across the Commercial organization to include, but not limited to, functioning as the business lead for sales sizing and alignment, field incentive compensation design and implementation, field analytics and reporting, implementation of commercial systems, collaboration with brand marketing/e-marketing initiatives and supporting KPIs for overall performance. Additionally, you will identify critical business issues and opportunities for growth, collaborate with cross-functional teams, and work to embed an external market point-of-view into the strategic direction of the company.Position Responsibilities: Strategic Leadership & Operational Excellence Define and implement a structured framework of goals and tactics to build a best-in-class Field and Sales Operations organization. Establish and maintain robust analytics and operational processes that effectively support the General Managers and Sales organization. Data Governance & Systems Integration Serve on a cross-functional data governance team to define business rules and processes that ensure data integrity and consistency. Partner with Sales and IT to design, deploy and maintain Veeva both in the US and ROW Provide Field Operation Support for ROW Ensure organizational compliance with CRM data standards and quality protocols. Sales Enablement & Field Optimization Train the commercial field sales team on systems, tools, and processes to maximize efficiency and adoption. Develop and refine field sizing and deployment strategies to optimize sales force effectiveness and meet business objectives. Manage territory alignment and roster systems to ensure optimal resource utilization. Manages the field sales force credentialling program Performance Management & Incentives Lead the development and execution of incentive compensation programs aligned with strategic goals, including plan design, governance, goal setting, reporting, and payout processing. Monitor departmental performance against KPIs and collaborate with commercial leadership to drive continuous improvement. Cross-Functional Collaboration & Commercial Readiness Oversee and execute a broad range of commercial initiatives to ensure organizational readiness for product launches. Collaborate across the Commercial team to align operational strategies with key business objectives and priorities. Candidate Requirements: Bachelor's degree in business, science or related field. A master's degree (MBA) strongly preferred. 8-10 years of experience working in the pharmaceutical or biotech industry with five plus years supporting field sales teams. Extensive experience supporting technical design of commercial systems. Implementation experience a must. Extensive experience with Veeva CRM, data management and incentive compensation Experience with Symphony, IQVIA. CROSSIX and related pharmaceutical sales data Experience working with field sales teams, field reporting and incentive compensation Strong analytical skills with the capability to appropriately define issues, questions and data; to comprehend quantitative methods and analytical techniques; to perform accurate analysis (correctly calculated numbers, accurate graphs); to cross-check data and assumptions; to document and establish data trails; and to think creatively about different ways to analyze data and information Excellent quantitative background that supports the analysis of data to better understand market dynamics and provide insights into product performance and marketing strategy. Strong interpersonal skills with demonstrated ability to drive toward consensus. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .