Director of Pharmaceutical Development

Company Overview Fulcrum Therapeutics, Inc. (NASDAQ: FULC) is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative small molecules aimed at enhancing the lives of patients with genetically defined rare diseases. Our mission is to instill hope and offer new treatment options for individuals affected by rare hematologic disorders. We are actively advancing a robust pipeline of clinical and preclinical assets, with our flagship product, pociredir, being a first-in-class small molecule designed to elevate fetal hemoglobin levels in the treatment of sickle cell disease and other hemoglobinopathies. As we expand our portfolio of clinical-stage assets, we are seeking a dynamic and strategic leader to oversee our Pharmaceutical Development function. Job Description As the Director of Pharmaceutical Development, you will report directly to the Head of Technical Operations. You will spearhead all drug product development initiatives encompassing technical, managerial, and financial dimensions. Your responsibilities will include formulation development, clinical trial material production, process optimization, scale-up, and validation. The ideal candidate will adeptly lead, plan, and manage both the technical and business-related components associated with drug product development and manufacturing at contract development and manufacturing organizations (CDMOs) for various dosage form programs. Key Responsibilities Direct and oversee all strategic and operational facets of drug product development at Fulcrum. Design and implement pharmaceutical product development plans aligned with corporate objectives for all development programs. Collaborate with cross-functional teams, including Drug Substance, Analytical, Clinical Operations, Quality Assurance, and Regulatory CMC, to ensure that plans are comprehensive, phase-appropriate, and executed on schedule. Lead pharmaceutical development efforts for the pociredir program, covering clinical trial material for pivotal studies, pre-validation studies, validation plans, and commercial launch supply. Manage product development, technology transfer, and clinical manufacturing activities at contract manufacturing organizations (CMOs), ensuring adherence to Regulatory and Quality standards. Oversee pediatric formulation development initiatives as needed. Review and approve a wide range of documents (e.g., MBRs, Specifications, Protocols, Reports) at CMOs. Generate, review, and approve documentation related to Drug Product (formulation, process development, manufacturing) for Regulatory submissions (IND/IMPD and NDA/MAA).

Join Ramboll as a Director of Life Science and Pharmaceutical Innovations, where you will play a pivotal role in shaping the future of healthcare. You will lead strategic initiatives, collaborating with a talented team to drive innovation and excellence within the life sciences and pharmaceutical sectors. Your expertise will guide the development of cutting-edge solutions that enhance patient outcomes and streamline processes.

As the Director of Biomarker Development at Scholar Rock, you will lead our innovative team in the discovery and validation of biomarkers that drive the development of transformative therapies. Your expertise will be crucial in guiding our biomarker strategies, collaborating with cross-functional teams, and ensuring alignment with our overall scientific objectives. We are seeking a visionary leader who is passionate about advancing precision medicine and dedicated to improving patient outcomes.

Join Alkeus Pharmaceuticals, a pioneering biopharmaceutical company dedicated to transforming the lives of patients with rare diseases. We are seeking a dynamic and visionary Medical Director to lead our clinical development activities, providing strategic direction and oversight for our innovative programs.As the Medical Director, you will collaborate with cross-functional teams, engage with key opinion leaders, and contribute to the development of cutting-edge therapies. This is an exceptional opportunity for a dedicated professional looking to make a significant impact in the field of rare diseases.

Imagine a scenario where you could be a part of a pioneering organization that not only creates but also nurtures life sciences companies dedicated to pioneering transformative technologies in healthcare and sustainability.Montai Therapeutics is a forward-thinking, privately held biotechnology firm that leverages artificial intelligence to unlock the potential of diverse chemistry, aiming to develop innovative oral medicines that effectively address longstanding unmet needs in chronic diseases. Through our cutting-edge CONECTA™ platform, we have established the world's premier foundation models that decode the intricate relationship between nature's bioactive chemistry and human biology, thus revolutionizing the drug discovery process with unmatched versatility and predictability.We have meticulously curated a collection of over 1 billion Anthromolecules™ and Anthrologs™, derived from compounds that humans have historically consumed through food, supplements, and herbal remedies. This extensive database has provided us with efficient access to a vast array of chemical diversity, enabling us to selectively and precisely influence complex biological systems. Montai is rapidly progressing a pipeline of groundbreaking oral medications targeting validated biological pathways in inflammation and immunology, with a focus on developing biologic replacements for traditionally challenging transcription factors.Position Overview:We are actively seeking a seasoned Head of Clinical Development to report directly to our Chief Executive Officer. This individual will hold primary responsibility for the strategic development and implementation of clinical programs for small molecules within the therapeutic realms of immunology and inflammation at Montai Therapeutics. We invite applications from highly motivated, collaborative, and results-driven professionals who possess the adaptability, creativity, and resourcefulness necessary to thrive in our dynamic environment.The Head of Clinical Development will be instrumental in steering the seamless transition of programs from research to clinical phases, as well as shaping comprehensive clinical strategies that encompass everything from candidate discovery to human proof-of-concept trials. As a pivotal leader in our clinical development efforts, this role involves the formulation and integration of clinical development plans that align with our research, translational, nonclinical, regulatory, and strategic goals. Additionally, this individual will oversee the teams responsible for supporting program operations, resource allocation, and interactions with both internal governance and external partners. This role is ideal for an experienced professional who is passionate about transforming innovative scientific discoveries into groundbreaking therapies through meticulous and collaborative planning and execution.

Join Integrated Resources, Inc. as a Pharmaceutical Research Associate, where you will play a vital role in advancing medical research and drug development. You will collaborate with a team of scientists and researchers to assist in the design and execution of clinical trials, ensuring the integrity and accuracy of data collection.Your contributions will help pave the way for innovative therapies that make a difference in patients' lives. Ideal candidates are detail-oriented, possess strong analytical skills, and have a passion for the pharmaceutical industry.

Amylyx Pharmaceuticals is on a bold mission to revolutionize the treatment of diseases with significant unmet needs. Where others perceive obstacles, we recognize opportunities that we pursue with a sense of urgency, scientific rigor, and steadfast dedication to the communities we serve. Our focus is currently on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our mission thrives on the commitment of our team. Our core values—be audacious, be curious, be authentic, be engaged, and be accountable—foster a culture of care. At Amylyx, we have assembled a highly skilled team eager to take decisive action because the communities we support cannot afford to wait. If you share our enthusiasm and are committed to addressing some of the most challenging problems in medicine, we invite you to explore the opportunity below and submit your application.The OpportunityThe Director of Clinical Sciences will play a pivotal role within the Clinical Development team, providing essential scientific guidance for ongoing projects. This position reports to a Medical Director and involves cross-functional collaboration with R&D, program management, clinical operations, biostatistics, and data management. The candidate will support and propel key developmental efforts for clinical studies and the execution of the overall Clinical Development Plans (CDP).

Amylyx Pharmaceuticals Inc. is on a bold mission to innovate the treatment landscape for diseases with significant unmet needs. Instead of viewing challenges as roadblocks, we embrace them as opportunities to advance solutions with urgency, scientific rigor, and a steadfast commitment to the communities we serve. As a clinical-stage company, we are currently addressing conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our mission thrives on the passion of our people. We embody core values of audacity, curiosity, authenticity, engagement, and accountability, fostering a culture of care. With a seasoned team ready to make impactful changes, we invite you to join us in this endeavor if you share our enthusiasm for tackling some of the most challenging issues in medicine.The OpportunityAmylyx Pharmaceuticals Inc. is seeking a seasoned Senior Director of Chemistry, Manufacturing, and Controls (CMC) to lead our CMC organization in the development of our pipeline, including Phase III synthetic peptide Avexitide and Phase I antisense oligonucleotide AMX0114. The CMC team partners with external CDMOs to implement robust, scalable, and compliant processes for clinical and commercial supply. This role may involve direct leadership or managing leads of internal matrix CMC Asset teams, serving as the CMC representative on Asset program teams. This leader will collaborate across functions to drive technical excellence and ensure CMC alignment with program objectives.The ideal candidate will exhibit strong strategic leadership while actively engaging in hands-on execution as needed. This position reports to the Senior Vice President of Global CMC and External Manufacturing.

As the Director of Market Access Marketing at Nuvalent, you will lead innovative marketing strategies that enhance access to our groundbreaking therapies. You will collaborate with cross-functional teams to develop compelling campaigns that resonate with healthcare providers and payers, ensuring that our products reach the patients who need them most. This role requires a strategic thinker with a deep understanding of the market landscape and a passion for improving patient outcomes.

Director of Business Development - USVCLS: Accelerating the Path to PatientsSince 1997, VCLS has been at the forefront of supporting innovators in biotech, Medtech, and Healthtech on their journey from discovery to market. We have a simple yet ambitious mission: to accelerate the delivery of life-changing products to patients. With over 230 industry experts globally, we are dedicated to our long-term vision of delivering 500 new healthtech products by 2050.We are currently on the lookout for a Director of Business Development - US—an experienced, hands-on leader—to implement our US commercial strategy with clarity, intention, and urgency. This role is perfect for an individual who views business development as a consultative art rather than just a transactional process, characterized by curiosity, empathy, and a genuine passion for Life Sciences.Key Results & AccountabilitiesDriving Growth Through Consultative Partnerships Propel significant revenue growth by cultivating strong, trust-based relationships within the biotech, medtech, healthtech, and investment sectors. Take charge of the complete business development lifecycle including listening, identifying opportunities, crafting solutions, and securing strategic partnerships. Exhibit total ownership of the sales process ensuring every client feels comprehensively understood and supported without any handoffs or gaps.Excellence in Client Engagement & Sales OwnershipThis role is committed to delivering a world-class consultative experience, anchored in scientific curiosity and deep client insight: Actively listen and convert client challenges into clear, actionable opportunities. Ensure that clients connect with the right VCLS experts at the right time to maximize value. Coordinate internal teams to facilitate meaningful discussions rather than generic interactions. Lead the development of proposals with meticulous attention, ensuring that each reflects a deep understanding and tailored solutions. Maintain outstanding responsiveness, clarity, and follow-through throughout the client engagement journey.Market Presence & Brand Elevation Represent VCLS credibly and passionately across the US market. Establish a prominent presence at industry events, within accelerators, investor networks, and innovation hubs. Enhance VCLS’s reputation as a reliable partner in regulatory strategy, clinical development, CMC, evidence generation, and commercialization.Stakeholder Leadership & Internal Alignment Collaborate closely with Business Unit leaders, scientific experts, and senior management to ensure seamless execution of business development initiatives. Encourage cross-functional teamwork to optimize client outcomes.

Job Summary: The Associate Director of Development at Harvard's Division of Continuing Education (DCE) will be instrumental in crafting, executing, and enhancing impactful annual giving and stewardship programs.As a vital part of DCE's Advancement team, the Associate Director of Development will report directly to the Director of Advancement, while also collaborating closely with the Faculty of Arts and Sciences (FAS) Development team. This reporting structure facilitates seamless coordination with FAS development teams, strategic alignment, and access to shared resources.The primary aim of DCE is to ensure consistent annual support while increasing awareness of the diverse engagement opportunities available across FAS.Key Responsibilities: Development StrategyEstablish and supervise strategies aimed at acquiring, retaining, and upgrading non-rated and non-managed donors contributing between $100 and $10,000, thereby creating a robust and sustainable donor pipeline for FAS Development.Formulate and direct DCE annual fund strategies, aligning fundraising priorities with institutional objectives and working closely with FAS to maximize donor engagement and opportunities.Ensure all fundraising communications adhere to content standards and align with best practices and University branding, utilizing FAS Development resources for strategic insights.Lead cross-functional, project-based initiatives that support DCE's fundraising goals, including outreach to emerging donor and volunteer communities.Develop, implement, and refine policies and procedures that promote consistent, scalable, and effective fundraising operations.Participate in various FAS, DCE, and University-wide meetings with teams involved in marketing, stewardship, annual giving, and research.Annual GivingOversee the strategic direction of annual giving programs in close collaboration with DCE's Director of Advancement and the FAS Development team, ensuring alignment with institutional priorities and revenue targets.Manage a portfolio of annual fund priorities, establishing goals, identifying value propositions, allocating resources, and assessing performance to drive sustainable growth.Utilize the alumni database to enhance annual giving strategies, focusing on donor segmentation and accurate management of biographical records. Initiate programs that encourage alumni to update their information, ensuring data integrity and enhanced engagement.Recruit, guide, and manage volunteer leaders within the Harvard Extension Alumni Association.

Join Harvard University as the Assistant Director of Development for the Harvard College Fund. In this pivotal role, you will be instrumental in shaping fundraising strategies and engaging with alumni and donors to enhance support for the college. You will work closely with senior leadership to develop and implement innovative approaches to fundraising that resonate with a broad audience.

Join Lila Sciences as the Director of Instrument Development Acceleration, where you will lead innovative projects aimed at advancing our cutting-edge instrument technologies. This role is pivotal in propelling our development efforts and driving strategic initiatives that will shape the future of our capabilities.

Harvard University is seeking a dynamic and strategic leader for the position of Associate Director of Development Administration. In this pivotal role, you will be responsible for overseeing various administrative functions within the Alumni Relations and Resource Development departments. You will work closely with senior management to implement effective strategies that enhance our fundraising initiatives and strengthen alumni engagement. Your expertise will be crucial in streamlining operations and ensuring that our development efforts are efficient and impactful.

Join Sobi as the Associate Director of European Supply Chain Management, where you will play a pivotal role in optimizing and managing our supply chain operations across Europe. You will lead a team of professionals, driving efficiency and ensuring that our products reach patients in a timely and effective manner. This is an exciting opportunity to contribute to the healthcare sector and make a meaningful impact.

Company Overview Metaphore Biotechnologies, Inc. is a pioneering biotechnology firm dedicated to developing the next generation of biological therapeutics. Our mission is to revolutionize patient care by harnessing the potential of biological therapeutics through an innovative mimic-discovery platform. Position Overview We are actively looking for a Senior Director of CMC Development & External Manufacturing to spearhead the comprehensive CMC strategy and execution for our biologics programs. This role entails significant accountability for formulating drug substance and drug product processes in collaboration with external manufacturing partners (CDMOs). The successful candidate will oversee the integrated CMC plan encompassing strategy, timelines, budgets, and risk management, while partnering with key internal stakeholders to ensure a smooth transition into late-stage CMC operations, thereby supporting regulatory submissions and clinical supply requirements.

Pioneering Medicines, part of Flagship Pioneering in Cambridge, MA, focuses on developing a wide range of new treatments by building on Flagship’s scientific platforms. The team collaborates with Flagship companies to expand into new therapeutic areas, aiming to bring innovative medicines to more patients faster. With a strong drug development team and access to Flagship’s broader network, Pioneering Medicines generates new therapeutic ideas both internally and through strategic partnerships. Role overview The Director of Business Development Transactions leads strategic transactions for Pioneering Medicines and selected Flagship companies. This position requires strong influence across all organizational levels, excellent organizational and communication skills, and the ability to present complex information clearly. Scientific understanding, strategic thinking, and a collaborative approach are essential, as is comfort working in an entrepreneurial setting. What you will do Lead the structuring, negotiation, and execution of in-licensing, out-licensing, and asset sale transactions for Pioneering Medicines. Negotiate a range of strategic transactions for companies within the Flagship ecosystem. Direct due diligence and financial analysis to support new deals. Present key findings and recommendations to company leadership and investment decision-makers. Additional responsibilities Collaborate with the Partnering team and cross-functional leaders to shape and execute Flagship’s business development strategy. Build credibility across the organization with a deep understanding of biotech and pharmaceutical deal-making. Prepare opportunity assessments, including scientific and portfolio rationale, partnership frameworks, financial evaluations, competitive analysis, and deal term comparisons.

Amylyx Pharmaceuticals is on a bold mission to revolutionize the treatment of diseases that have significant unmet needs. We view challenges as opportunities to pursue with urgency, scientific rigor, and an unwavering commitment to the communities we serve. As a clinical-stage company, we are dedicated to tackling complex conditions including post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Powered by our dedicated team, our core values—be audacious, be curious, be authentic, be engaged, and be accountable—foster a caring culture. We are seeking passionate individuals who are eager to confront some of medicine’s most pressing challenges. If you are ready to take action, we invite you to explore the opportunity below and apply.The OpportunityThe Senior Director of Market Insights is a pivotal leadership role that will drive the comprehensive insights strategy to facilitate U.S. commercialization and global expansion. As the strategic owner of the insights function, you will ensure the integration of market intelligence, analytics, and evidence generation into corporate decision-making throughout the product lifecycle.Reporting to the Vice President of Commercial Operations, you will be a key advisor to both commercial and executive leadership, shaping strategies with insights that guide launch readiness, lifecycle management, and portfolio prioritization. This role requires adeptness at both strategic and operational levels, building scalable frameworks to support a multi-asset, multi-market organization.

Scholar Rock is a pioneering biopharmaceutical firm dedicated to discovering, developing, and delivering transformative therapies for individuals afflicted by severe diseases with significant unmet medical needs. Renowned for its leadership in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins, the company has established a strong clinical focus on advancing groundbreaking treatments that leverage protein growth factors. Over the last decade, Scholar Rock has developed a robust pipeline aiming to redefine the standard of care for neuromuscular diseases, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted therapies can create profound impacts. As the sole organization to demonstrate clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA), Scholar Rock is committed to pioneering innovative therapeutic strategies. This commitment is bolstered by the extensive application of its proprietary platform, which has successfully generated novel monoclonal antibodies designed to modulate protein growth factors with remarkable precision. By harnessing advanced scientific methodologies in historically underserved disease areas, Scholar Rock is dedicated to expanding treatment possibilities for patients. Discover more about our unique approach at ScholarRock.com and connect with us on @ScholarRock and LinkedIn.Position Overview:We are on the lookout for a strategic and experienced Director of Upstream MSAT and Process Development to lead our biologics upstream MSAT and process development initiatives across early, late, and commercial program stages. This pivotal role will oversee externally partnered GMP production of Scholar Rock’s clinical and commercial assets, leveraging extensive manufacturing science and technology expertise. The successful candidate will spearhead the design, scale-up, and technology transfer of drug substance processes, both internally and through our global network of CDMOs. The ideal candidate will possess profound upstream technical knowledge, exceptional organizational leadership, and a proven track record in managing external collaborations alongside in-house teams. This role is essential for establishing resilient and scalable processes that underpin our clinical and commercial success.

About BlueRock TherapeuticsBlueRock Therapeutics LP is a pioneering clinical-stage company focused on innovative cell therapies aimed at addressing neurological and ophthalmic disorders. Our leading investigational therapies, bemdaneprocel (BRT-DA01) for Parkinson’s disease and OpCT-001 for primary photoreceptor diseases, are at the forefront of clinical development. Established in 2016 as a collaboration between Versant Ventures and Leaps by Bayer, BlueRock embodies a culture defined by resilience, urgency in transforming healthcare, integrity in our mission, and a sense of community that emphasizes our collective purpose.Our VisionWe are harnessing advanced scientific techniques to guide the differentiation of universal pluripotent stem cells into authentic, functional cells, paving the way for allogeneic cellular therapies that can tackle a wide range of diseases. Our commitment to cellular and gene therapy is shaping the future of medicine and providing hope through new therapeutic options for countless patients.We are looking for talented individuals who thrive in a collaborative environment, embrace a dynamic workplace culture, and are dedicated to advancing innovative cellular therapies that will significantly impact patients' lives.The Director of Medical Writing will offer strategic and operational leadership across all Medical Writing initiatives to support BlueRock’s project portfolio from early development stages through to product registration.This role will be responsible for establishing and managing a cohesive Medical Writing function that produces high-quality regulatory documents in alignment with BlueRock’s global strategy, development timelines, and corporate objectives. The Director will lead an internal medical writing team, oversee vendor collaborations, and act as a key strategic partner to various departments including Regulatory Affairs, Pharmacovigilance, Clinical Development, Clinical Operations, Biometrics, Translational Science, and Technical Operations. Additionally, this role will play a crucial part in evolving capabilities such as AI-enabled medical writing, content reuse strategies, and collaborative models with Bayer teams.